<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2 20190208//EN" "http://jats.nlm.nih.gov/publishing/1.2/JATS-journalpublishing1.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" article-type="other" dtd-version="1.2" xml:lang="en">
    <front>
        <journal-meta>
            <journal-id journal-id-type="pmc">F1000Research</journal-id>
            <journal-title-group>
                <journal-title>F1000Research</journal-title>
            </journal-title-group>
            <issn pub-type="epub">2046-1402</issn>
            <publisher>
                <publisher-name>F1000 Research Limited</publisher-name>
                <publisher-loc>London, UK</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="doi">10.12688/f1000research.149731.1</article-id>
            <article-categories>
                <subj-group subj-group-type="heading">
                    <subject>Study Protocol</subject>
                </subj-group>
                <subj-group>
                    <subject>Articles</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>Effect of osteopathic manipulation using SSDV protocol on improving motor coordination and hand eye coordination in children with developmental coordination disorder: a protocol for randomized controlled trial</article-title>
                <fn-group content-type="pub-status">
                    <fn>
                        <p>[version 1; peer review: awaiting peer review]</p>
                    </fn>
                </fn-group>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author" corresp="yes">
                    <name>
                        <surname>Hullumani</surname>
                        <given-names>Sharath</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Funding Acquisition</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Software</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <role content-type="http://credit.niso.org/">Visualization</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0009-0000-2926-5609</uri>
                    <xref ref-type="corresp" rid="c1">a</xref>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Raghuveer</surname>
                        <given-names>Raghumahanti</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Software</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <role content-type="http://credit.niso.org/">Visualization</role>
                    <uri content-type="orcid">https://orcid.org/0000-0001-7696-0786</uri>
                    <xref ref-type="aff" rid="a2">2</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Qureshi</surname>
                        <given-names>Moh&#x2019;d Irshad</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Software</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <xref ref-type="aff" rid="a2">2</xref>
                </contrib>
                <aff id="a1">
                    <label>1</label>Assistant Professor, Department of Paediatric Physiotherapy, Center for Advanced Physiotherapy Education &amp; Research, Ravi Nair Physiotherapy College, Datta Meghe Institute Higher Education and Research (DU), Sawnagi Meghe, Wardha, MH, 442001, India</aff>
                <aff id="a2">
                    <label>2</label>Professor, Department of Neuro Physiotherapy, Center for Advanced Physiotherapy Education &amp; Research, Ravi Nair Physiotherapy College, Datta Meghe Institute Higher Education and Research (DU),, Sawangi Meghe, wardha, MA, 442001, India</aff>
            </contrib-group>
            <author-notes>
                <corresp id="c1">
                    <label>a</label>
                    <email xlink:href="mailto:sharathhullumani@gmail.com">sharathhullumani@gmail.com</email>
                </corresp>
                <fn fn-type="conflict">
                    <p>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>17</day>
                <month>5</month>
                <year>2024</year>
            </pub-date>
            <pub-date pub-type="collection">
                <year>2024</year>
            </pub-date>
            <volume>13</volume>
            <elocation-id>485</elocation-id>
            <history>
                <date date-type="accepted">
                    <day>3</day>
                    <month>5</month>
                    <year>2024</year>
                </date>
            </history>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2024 Hullumani S et al.</copyright-statement>
                <copyright-year>2024</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <self-uri content-type="pdf" xlink:href="https://f1000research.com/articles/13-485/pdf"/>
            <abstract>
                <p>Developmental Coordination Disorder (DCD) significantly impacts motor coordination and hand-eye coordination in children, affecting their daily activities and academic performance. This study aims to investigate the efficacy of Physical Rehabilitation utilizing the Sensory Stimulation and Developmental Vestibular (SSDV) protocol in improving motor coordination and hand-eye coordination in children diagnosed with DCD. Children diagnosed with DCD will be recruited and randomly allocated to either the intervention group receiving Physical Rehabilitation using the SSDV protocol or the control group receiving standard care. The intervention will involve a structured program incorporating sensory stimulation and developmental vestibular activities tailored to the individual needs of participants. Motor coordination and hand-eye coordination will be assessed using standardized measures such as the Movement Assessment Battery for Children (MABC) and the Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI). Assessments will be conducted at baseline, post-intervention, and follow-up time points. This randomized controlled trial seeks to evaluate the effectiveness of Physical Rehabilitation using the SSDV protocol in enhancing motor coordination and hand-eye coordination in children with DCD. By employing standardized measures, this study aims to provide objective insights into the impact of the intervention. Findings from this trial may contribute to the development of evidence-based interventions for children with DCD, potentially improving their motor skills and overall functioning in daily life and academic settings.</p>
                <p>Registration: 
                    <bold>CTRI/2024/03/064467</bold>
                </p>
            </abstract>
            <kwd-group kwd-group-type="author">
                <kwd>ADHD</kwd>
                <kwd>DCD</kwd>
                <kwd>Physiotherapy</kwd>
            </kwd-group>
            <funding-group>
                <funding-statement>The author(s) declared that no grants were involved in supporting this work.</funding-statement>
            </funding-group>
        </article-meta>
    </front>
    <body>
        <sec id="sec1" sec-type="intro">
            <title>Introduction</title>
            <p>Developmental coordination disorder (DCD) is a rather common movement disorder among primary school-aged children; its prevalence rates range between 6% and 10% worldwide. The motor impairment of children with developmental coordination disorder (DCD) (e.g., marked delays in achieving motor milestones, movement clumsiness, poor performance in sports, or poor handwriting) inevitably interferes with their activities of daily living and academic achievement.
                <sup>
                    <xref ref-type="bibr" rid="ref1">1</xref>
                </sup>
                <sup>,</sup>
                <sup>
                    <xref ref-type="bibr" rid="ref2">2</xref>
                </sup> In order for a child to be diagnosed with developmental coordination disorder (DCD), these motor impairments must negatively affect some other aspect of his or her life. Impairment alone, however, does not qualify a child for the diagnosis of developmental coordination disorder (DCD); the motor impairment must not be caused by or have the symptoms of an identifiable neurological problem. That is, the child must not have any disturbances of muscle tone (ataxia or spasticity), sensory loss, or involuntary movements. If mental retardation is present, the testable IQ of the child must be greater than 70 and the motor impairments must be greater than what would normally be expected for children with mental retardation. Finally, a child diagnosed with developmental coordination disorder (DCD) must not meet the criteria for a diagnosis of pervasive developmental disorder.
                <sup>
                    <xref ref-type="bibr" rid="ref3">3</xref>
                </sup>
                <sup>&#x2013;</sup>
                <sup>
                    <xref ref-type="bibr" rid="ref6">6</xref>
                </sup> The prevalence ranges between 1.8% and 8%, depending on the diagnostic criteria used, based on the cut off of motor scores from standardized scales. Four main hypotheses have been postulate to explain DCD in terms of deficits in visuospatial functions, procedural learning, internal modeling, or executive functions. Neuroimaging studies are scarce but have highlighted several brain regions, including the parietal, frontal, and cerebellar cortices. Meta-analyses have supported task-oriented approaches as effective therapies to improve motor performance in children with DCD.
                <sup>
                    <xref ref-type="bibr" rid="ref7">7</xref>
                </sup>
                <sup>&#x2013;</sup>
                <sup>
                    <xref ref-type="bibr" rid="ref10">10</xref>
                </sup>
            </p>
            <p>Due to the heterogeneity of DCD, finding its cause has been difficult. Several theories speculate that the etiology of DCD is part of the continuum of cerebral palsy is se condary to prenatal, prenatal, or neonatal insult or is secondary to neuronal damage at the cellular level in the neurotransmitter or receptor systems.
                <sup>
                    <xref ref-type="bibr" rid="ref11">11</xref>
                </sup>
                <sup>,</sup>
                <sup>
                    <xref ref-type="bibr" rid="ref12">12</xref>
                </sup> A common concern in the literature is the psychosocial problems showed by DCD children. A number of studies based on observational behavior and standardized questionnaires showed more symptoms of depression and stress/anxiety such as sadness, agitation and panic, low self-esteem in children with DCD compared with their typically developing peers. Further, a longitudinal study showed that motor difficulties at infancy and early childhood are related with psychosocial symptoms during adolescence. Motor difficulties of children with DCD appear to substantially affect psychosocial behavior from infancy through adolescence. The modulation of ANS, however, remains open for an objective neurophysiological assessment of stress/anxiety in children with DCD.</p>
        </sec>
        <sec id="sec2">
            <title>Objectives</title>
            <p>The objectives of the present study are:
                <list list-type="order">
                    <list-item>
                        <label>1.</label>
                        <p>To determine the changes in motor skills in children with developmental coordination disorder</p>
                    </list-item>
                    <list-item>
                        <label>2.</label>
                        <p>To determine the changes in eye hand coordination in children with developmental coordination disorder</p>
                    </list-item>
                </list>
            </p>
            <sec id="sec3">
                <title>Protocol</title>
                <p>This protocol has been registered with CTRI registration number CTRI/2024/03/064467.</p>
            </sec>
            <sec id="sec4">
                <title>Ethics and consent</title>
                <p>This study will be conducted with written informed consent from all participants. Ethical approval was received from Datta Meghe Institute of Higher Education and research (DU), Sawangi (Meghe), Wardha, on 30th January 2024 with Ref No. DMIHER/IEC/2024/149.</p>
            </sec>
            <sec id="sec5">
                <title>Trial design</title>
                <p>It is a two-arm parallel group, equal allocation superiority trial.</p>
                <p>The patients will be screened according to inclusion and exclusion criteria and will be recruited from Physiotherapy OPD of Acharya Vinoba Bhave Rural Hospital, Sawangi Wardha and OPD of Ravi Nair Physiotherapy College, Salod, Wardha. Then informed consent will be given. If the patients are agreed to gives the consent, then patient will be selected by based on eligibility criteria. Procedure of the study will be explained to all the patients and written consent will be taken from them. Patients with Autism will be allocated for the study. Post treatment the same outcome measure will be given. The group A will be receiving SSDV Protocol and Conventional Physiotherapy for 45 minutes a day, 5 days per week for 4 weeks (
                    <xref ref-type="table" rid="T1">Table 1</xref>). The group B will be receiving Conventional Physiotherapy for 45 minutes a day, 5 days per week for 4 weeks (
                    <xref ref-type="table" rid="T2">Table 2</xref>). Both groups will receive treatment for 4 sessions, 5 days per week for 4 weeks and two days gap after each session. Baseline and follow-up visits at second weeks and four weeks after treatment will be carried out, where primary as well as secondary variables will be assessed.</p>
                <table-wrap id="T1" orientation="portrait" position="float">
                    <label>Table 1. </label>
                    <caption>
                        <title>SSDV Treatment protocol for patients with ADHD.</title>
                    </caption>
                    <table content-type="article-table" frame="hsides">
                        <thead>
                            <tr>
                                <th align="left" colspan="1" rowspan="1" valign="top">SL. NO.</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Technique</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Procedure</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Intensity</th>
                            </tr>
                        </thead>
                        <tbody>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">1</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Sub occipital release technique</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">The subject lies in supine and therapist sitting cranially to subject and placing tips of fingers at sub occipital muscles and will slowly keep the pressure with fingers anteriorly and the gravity will help and the muscles will start melting the force applying anteriorly should be maintained until the tissue melted.</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">The procedure can be repeated 2-3 times depends on patient sensitivity.</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">2</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Sternocleidomastoid fascial release</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">The subject lies in supine and therapist standing on ipsilateral side at the level of cervicale&#x2019;s of subject then rotating the subject head to contralateral side passively so that the muscle is easily palpable then therapist use the fingers to glide over myo-fascia and stretch it.</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">The procedure can be repeated 2 to 3 times depending on tonicity of muscle.</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">3</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Diaphragm mobilization</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">The subject lies in supine and therapist standing at the level of costal arch of ribs and will place both hands at costal arch&#x2019;s and will start mobilizing the diaphragm in figure of 8. Should be done in rhythmic way with breathing with out making patient fell discomfort.</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">The procedure can be repeated 2 to 3 times depending on mobility of diaphragm.</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">4</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Visceral manipulation
                                    <break/>
                                    <break/>
                                    <p>
                                        <list list-type="order">
                                            <list-item>
                                                <label>1)</label>
                                                <p>End to end stretch of the descending Colon</p>
                                            </list-item>
                                            <list-item>
                                                <label>2)</label>
                                                <p>End to end stretch of the ascending Colon</p>
                                            </list-item>
                                            <list-item>
                                                <label>3)</label>
                                                <p>Peritoneum grasping technique</p>
                                            </list-item>
                                        </list>
                                    </p>
                                </td>
                                <td align="left" colspan="1" rowspan="1" valign="top">The subject is lying in side line position facing right, legs bent. The therapist sanding posterior to subject with the right hand, curl the fingers under the right costal arch in posterosuperior and laterally in the direction of the right colic flexure. And with the left hand grab and hold the beginning end of ascending colon which is located at level of iliac crest and stabilise or fix it posteriorly. With the right hand apply the force in posterosuperior and laterally and left hand inferior which results in a lengthwise stretch of the descending colon.
                                    <break/>The subject is lying in side line position facing left, legs bent. The therapist sanding posterior to subject with the left hand, curl the fingers under the right costal arch in posterosuperior and laterally in the direction of the right colic flexure. And with the right hand grab and hold the beginning end of ascending colon which is located at level of iliac crest and stabilise or fix it posteriorly. With the left hand apply the force in posterosuperior and laterally and right hand inferior which results in a lengthwise stretch of the ascending colon.
                                    <break/>The subject is lying in supine, legs bent. The therapist stands at the level of abdomen with the help of both hands therapist should find the tone and tensions in abdomen area once found the tissue at that area is grasped and pulled anteriorly and should be holed for 30sec to 1 minute the grasping should not only be at abdominal wall level it should reach the peritoneum.</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">The procedure can be repeated 2 to 3 times depends on patient sensitivity.
                                    <break/>The procedure can be repeated 2 to 3 times depends on patient sensitivity.
                                    <break/>The technique should be applied with caution as it is very painful but can be repeated two times according to patient response.</td>
                            </tr>
                        </tbody>
                    </table>
                    <table-wrap-foot>
                        <p>Acronym of SSDV, S: Sub occipital release technique; S: Sternocleidomastoid fascial release; D: Diaphragm mobilization; V: Visceral Manipulation.</p>
                    </table-wrap-foot>
                </table-wrap>
                <table-wrap id="T2" orientation="portrait" position="float">
                    <label>Table 2. </label>
                    <caption>
                        <title>Conventional Physiotherapy.</title>
                    </caption>
                    <table content-type="article-table" frame="hsides">
                        <thead>
                            <tr>
                                <th align="left" colspan="1" rowspan="1" valign="top">Sr No.</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Treatment</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Description</th>
                                <th align="left" colspan="2" rowspan="1" valign="top">Frequency</th>
                            </tr>
                        </thead>
                        <tbody>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">1)</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Auditory Integration Training (AIT)</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">AIT involves listening to filtered, modulated music that presents sounds of varying volumes and pitches</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">10 min session day/week</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">1 per</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">2)</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Sensory Integration Therapy (SIT)</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Sensory integration therapy is intended to focus directly on the neurological processing of sensory information as a foundation for learning of higher-level skills</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">10 min session day/week</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">1 per</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">3)</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Holding Therapy</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">The theory behind its use is that autism results from a lack of appropriate attachment of the child to mother</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">10 min session day/week</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">1 per</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">4)</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Facilitated Communication</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Facilitated communication is a technique where a trained facilitator physically guides the hand of a nonverbal child using an output device such as a keyboard, typewriter or similar device to spell</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">10 min session day/week</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">1 per</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">5)</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">Music Therapy</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">The theory behind using music therapy is that certain processes that occur in musical improvisation may help people with ASD to develop their capacity for social interaction and communicative skills</td>
                                <td align="left" colspan="2" rowspan="1" valign="top">5 min 1 session per day/week</td>
                            </tr>
                        </tbody>
                    </table>
                </table-wrap>
            </sec>
            <sec id="sec6">
                <title>Inclusion criteria</title>
                <p>
                    <list list-type="order">
                        <list-item>
                            <label>1.</label>
                            <p>Both Gender</p>
                        </list-item>
                        <list-item>
                            <label>2.</label>
                            <p>Age from 6 to 14 years</p>
                        </list-item>
                        <list-item>
                            <label>3.</label>
                            <p>Participants must have a confirmed diagnosis of DCD based on recognized diagnostic criteria such as DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) or other standardized diagnostic tools</p>
                        </list-item>
                        <list-item>
                            <label>4.</label>
                            <p>Cognitive Functioning: Depending on the study&#x2019;s focus, participants may be required to have a certain level of cognitive functioning. This could be assessed using standardized cognitive tests.</p>
                        </list-item>
                        <list-item>
                            <label>5.</label>
                            <p>Communication Skills: Consider including participants with a range of communication abilities or specify a particular communication level if relevant to the study. This may involve verbal and non-verbal communication skills.</p>
                        </list-item>
                    </list>
                </p>
            </sec>
            <sec id="sec7">
                <title>Exclusion criteria</title>
                <p>
                    <list list-type="order">
                        <list-item>
                            <label>1.</label>
                            <p>
                                <bold>Other neurodevelopmental disorders:</bold> Exclude individuals with co-existing neurodevelopmental disorders, such as intellectual disabilities or other conditions that might confound the study results.</p>
                        </list-item>
                        <list-item>
                            <label>2.</label>
                            <p>
                                <bold>Unstable psychiatric conditions:</bold> Exclude individuals with unstable psychiatric conditions or severe comorbid mental health disorders that may interfere with the study outcomes.</p>
                        </list-item>
                        <list-item>
                            <label>3.</label>
                            <p>
                                <bold>Severe medical conditions:</bold> Exclude participants with severe medical conditions that could compromise their ability to participate safely in the trial or interfere with the study outcomes.</p>
                        </list-item>
                        <list-item>
                            <label>4.</label>
                            <p>
                                <bold>Seizure disorders:</bold> Exclude individuals with severe or uncontrolled seizure disorders that may pose a risk during the study.</p>
                        </list-item>
                    </list>
                </p>
            </sec>
            <sec id="sec8">
                <title>Participant timeline</title>
                <p>Data will be collected on the baseline as pre and post-data, followed by intervention for 4 weeks and post-intervention data on the last day of the 4
                    <sup>th</sup> week is again recorded.</p>
            </sec>
            <sec id="sec9">
                <title>Outcomes</title>
                <p>
                    <list list-type="order">
                        <list-item>
                            <label>1.</label>
                            <p>Vanderbilt ADHD Diagnostic Parent Rating Scale</p>
                        </list-item>
                        <list-item>
                            <label>2.</label>
                            <p>SNAP-IV rating scale</p>
                        </list-item>
                        <list-item>
                            <label>3.</label>
                            <p>Child behaviour checklist scoring scale</p>
                        </list-item>
                        <list-item>
                            <label>4.</label>
                            <p>Movement Assessment Battery for Children&#x2013;Second Edition</p>
                        </list-item>
                    </list>
                    <list list-type="order">
                        <list-item>
                            <label>1.</label>
                            <p>
                                <bold>Vanderbilt ADHD diagnostic parent rating scale</bold>: This scale is widely used by clinicians and researchers to assess ADHD symptoms in children based on parent-reported behaviors. It covers a range of symptoms related to inattention, hyperactivity, and impulsivity, as well as behaviors that may co-occur with ADHD, such as oppositional behavior and anxiety. The scale provides valuable information for diagnosing ADHD and monitoring treatment progress.</p>
                        </list-item>
                        <list-item>
                            <label>2.</label>
                            <p>
                                <bold>Corners rating scale</bold>: The Corners Rating Scale is a tool used in various fields such as psychology, education, and business to evaluate or rate different aspects or dimensions of a particular phenomenon, behavior, or entity. It typically involves assigning scores or ratings to specific criteria or dimensions, often represented along a numerical or descriptive scale. The name &#x201c;Corners&#x201d; might suggest that the scale assesses various corners or facets of a situation, concept, or behavior. Each corner could represent a different aspect or dimension being evaluated. The scale could range from simple binary options (e.g., yes/no) to more complex rating systems with multiple levels or categories. For example, in psychology, the Corners Rating Scale might be used to assess different aspects of personality, such as extraversion, agreeableness, conscientiousness, emotional stability, and openness to experience. Each &#x201c;corner&#x201d; could represent one of these personality traits, and individuals might be rated on each trait using a numerical scale or descriptive categories. Similarly, in education, the Corners Rating Scale could be used to evaluate different dimensions of student performance or behavior, such as academic achievement, social skills, classroom behavior, and motivation.</p>
                            <p>In business, the scale could be applied to evaluate various aspects of a product or service, such as quality, reliability, affordability, and customer satisfaction. The specific criteria or dimensions assessed by the Corners Rating Scale would depend on the context in which it is used and the goals of the evaluation. The scale provides a structured way to assess multiple facets of a complex phenomenon, allowing for a more comprehensive understanding or evaluation.</p>
                        </list-item>
                        <list-item>
                            <label>3.</label>
                            <p>
                                <bold>Attenetional control scale</bold>: The Attentional Control Scale (ACS) was developed by Derryberry and Reed in 2002. It consists of 20 items designed to measure two aspects of attentional control: focusing and shifting. Respondents rate each item on a scale, typically ranging from 1 (almost never) to 4 (always), indicating how well each statement describes their behavior or experience.</p>
                            <p>The focusing aspect assesses the ability to maintain attention on a task despite distractions or competing stimuli. Example items might include statements like &#x201c;I find it difficult to keep my mind on a task that is not interesting&#x201d; or &#x201c;I can concentrate easily.&#x201d;</p>
                            <p>The shifting aspect evaluates the ability to switch attention between different tasks or stimuli efficiently. Example items for this aspect might include statements like &#x201c;I am able to shift back and forth between different tasks easily&#x201d; or &#x201c;I find it easy to stop thinking about one thing and start thinking about something else.&#x201d;</p>
                            <p>Scores on the Attentional Control Scale can provide insight into an individual&#x2019;s cognitive functioning, particularly their ability to manage attentional resources effectively. Higher scores indicate greater attentional control, while lower scores suggest difficulties in regulating attention. The Attentional Control Scale has been used in various research settings, including studies related to attention-deficit/hyperactivity disorder (ADHD), anxiety disorders, and cognitive neuroscience. It helps researchers and clinicians understand individual differences in attentional abilities and how these differences relate to various cognitive and behavioral outcomes.</p>
                        </list-item>
                        <list-item>
                            <label>4.</label>
                            <p>
                                <bold>SNAP-IV rating scale</bold>: The SNAP-IV (Swanson, Nolan, and Pelham-IV) rating scale is another commonly used tool for assessing ADHD symptoms. It is typically completed by parents, teachers, or clinicians and evaluates the frequency and severity of ADHD symptoms, including inattention, hyperactivity, and impulsivity. The scale helps to differentiate between ADHD subtypes and assess treatment response.</p>
                        </list-item>
                        <list-item>
                            <label>5.</label>
                            <p>
                                <bold>Child behavior checklist (CBCL) scoring scale</bold>: The CBCL is a comprehensive questionnaire completed by parents to assess various behavioral and emotional problems in children and adolescents. It covers a broad range of issues, including internalizing and externalizing behaviors, social problems, and emotional difficulties. The CBCL provides valuable information for diagnosing and monitoring a wide range of behavioral and emotional disorders, including ADHD.</p>
                        </list-item>
                        <list-item>
                            <label>6.</label>
                            <p>
                                <bold>Movement assessment battery for children&#x2013;second edition (MABC-2)</bold>: The MABC-2 is a standardized assessment tool used to evaluate motor skills and coordination in children aged 3 to 16 years. It consists of several tasks that assess manual dexterity, aiming and catching, and balance skills. The MABC-2 helps identify motor coordination difficulties and can be useful in diagnosing developmental coordination disorder (DCD) or assessing motor deficits in children with ADHD or other neurodevelopmental disorders.</p>
                        </list-item>
                    </list>
                </p>
            </sec>
            <sec id="sec10">
                <title>Sample size calculation</title>
                <p>
                    <disp-formula id="e1">
                        <mml:math display="block">
                            <mml:mfrac>
                                <mml:mrow>
                                    <mml:msup>
                                        <mml:mrow>
                                            <mml:mo stretchy="true">(</mml:mo>
                                            <mml:msub>
                                                <mml:mi mathvariant="normal">Z</mml:mi>
                                                <mml:mrow>
                                                    <mml:mo stretchy="true">(</mml:mo>
                                                    <mml:mi mathvariant="normal">&#x03b1;</mml:mi>
                                                    <mml:mo>/</mml:mo>
                                                    <mml:mn>2</mml:mn>
                                                    <mml:mo stretchy="true">)</mml:mo>
                                                </mml:mrow>
                                            </mml:msub>
                                            <mml:mo>+</mml:mo>
                                            <mml:msub>
                                                <mml:mi mathvariant="normal">Z</mml:mi>
                                                <mml:mi mathvariant="normal">&#x03b2;</mml:mi>
                                            </mml:msub>
                                            <mml:mo stretchy="true">)</mml:mo>
                                        </mml:mrow>
                                        <mml:mn>2</mml:mn>
                                    </mml:msup>
                                    <mml:mrow>
                                        <mml:mo stretchy="true">(</mml:mo>
                                        <mml:msub>
                                            <mml:mi mathvariant="normal">P</mml:mi>
                                            <mml:mn>1</mml:mn>
                                        </mml:msub>
                                        <mml:mrow>
                                            <mml:mo stretchy="true">(</mml:mo>
                                            <mml:mn>1</mml:mn>
                                            <mml:mo>&#x2212;</mml:mo>
                                            <mml:msub>
                                                <mml:mi mathvariant="normal">P</mml:mi>
                                                <mml:mn>1</mml:mn>
                                            </mml:msub>
                                            <mml:mo stretchy="true">)</mml:mo>
                                        </mml:mrow>
                                        <mml:mo stretchy="true">)</mml:mo>
                                    </mml:mrow>
                                    <mml:mo>+</mml:mo>
                                    <mml:msup>
                                        <mml:mrow>
                                            <mml:mo stretchy="true">(</mml:mo>
                                            <mml:msub>
                                                <mml:mi mathvariant="normal">P</mml:mi>
                                                <mml:mn>2</mml:mn>
                                            </mml:msub>
                                            <mml:mrow>
                                                <mml:mo stretchy="true">(</mml:mo>
                                                <mml:mn>1</mml:mn>
                                                <mml:mo>&#x2212;</mml:mo>
                                                <mml:msub>
                                                    <mml:mi mathvariant="normal">P</mml:mi>
                                                    <mml:mn>2</mml:mn>
                                                </mml:msub>
                                                <mml:mo stretchy="true">)</mml:mo>
                                            </mml:mrow>
                                            <mml:mo stretchy="true">)</mml:mo>
                                        </mml:mrow>
                                        <mml:mn>2</mml:mn>
                                    </mml:msup>
                                </mml:mrow>
                                <mml:mrow>
                                    <mml:msup>
                                        <mml:mrow>
                                            <mml:mo stretchy="true">(</mml:mo>
                                            <mml:msub>
                                                <mml:mi mathvariant="normal">P</mml:mi>
                                                <mml:mn>2</mml:mn>
                                            </mml:msub>
                                            <mml:mo>&#x2212;</mml:mo>
                                            <mml:msub>
                                                <mml:mi mathvariant="normal">P</mml:mi>
                                                <mml:mn>1</mml:mn>
                                            </mml:msub>
                                            <mml:mo stretchy="true">)</mml:mo>
                                        </mml:mrow>
                                        <mml:mn>2</mml:mn>
                                    </mml:msup>
                                </mml:mrow>
                            </mml:mfrac>
                        </mml:math>
                    </disp-formula>
                    <disp-formula id="e2">
                        <mml:math display="block">
                            <mml:msub>
                                <mml:mi mathvariant="normal">Z</mml:mi>
                                <mml:mrow>
                                    <mml:mi mathvariant="normal">&#x03b1;</mml:mi>
                                    <mml:mo>/</mml:mo>
                                    <mml:mn>2</mml:mn>
                                </mml:mrow>
                            </mml:msub>
                            <mml:mo>=</mml:mo>
                            <mml:mi>at</mml:mi>
                            <mml:mspace width="0.40em"/>
                            <mml:mn>95</mml:mn>
                            <mml:mo>%</mml:mo>
                            <mml:mrow>
                                <mml:mo stretchy="true">(</mml:mo>
                                <mml:mi>CI</mml:mi>
                                <mml:mo stretchy="true">)</mml:mo>
                            </mml:mrow>
                            <mml:mo>=</mml:mo>
                            <mml:mn>1.96</mml:mn>
                        </mml:math>
                    </disp-formula>
                </p>
                <p>Represents the desired level of statistical significance</p>
                <p>
                    <inline-formula>
                        <mml:math display="inline">
                            <mml:msub>
                                <mml:mi>Z</mml:mi>
                                <mml:mi>&#x03b2;</mml:mi>
                            </mml:msub>
                            <mml:mo>=</mml:mo>
                            <mml:mn>0.84</mml:mn>
                        </mml:math>
                    </inline-formula> Represents the desired power = 0.80 for 80%
                    <disp-formula id="e3">
                        <mml:math display="block">
                            <mml:mi mathvariant="normal">N</mml:mi>
                            <mml:mo>=</mml:mo>
                            <mml:mtext>Minimum samples required for each group</mml:mtext>
                        </mml:math>
                    </disp-formula>
                </p>
                <p>Ratio allocation (Group2/Group1) = 1</p>
                <p>Sample size = 26 per group.</p>
                <p>Considering 15 % drop out total = 4</p>
                <p>Total 30 samples required per group.</p>
            </sec>
            <sec id="sec11">
                <title>Methods: data collection, management, and analysis</title>
                <p>
                    <list list-type="order">
                        <list-item>
                            <label>1)</label>
                            <p>Allocation
                                <list list-type="alpha-upper">
                                    <list-item>
                                        <label>A)</label>
                                        <p>Sequence generation: Computer-generated random numbers will be used for the study.</p>
                                    </list-item>
                                    <list-item>
                                        <label>B)</label>
                                        <p>Allocation concealment mechanism: Simple random Sampling-Computer generated random numbers will be used for the randomization of the study subjects.</p>
                                    </list-item>
                                    <list-item>
                                        <label>C)</label>
                                        <p>Implementation: The random number sequence will be generated by a blinded person from a non-healthcare background. Enrolment and assignment of participants to the interventions will be done by the Principal Investigator of the study.</p>
                                    </list-item>
                                </list>
                            </p>
                        </list-item>
                        <list-item>
                            <label>2)</label>
                            <p>Blinding: The trial participants will be blinded to the intervention.</p>
                        </list-item>
                    </list>
                </p>
            </sec>
            <sec id="sec12">
                <title>Methods: data collection, management, and analysis</title>
                <p>
                    <list list-type="order">
                        <list-item>
                            <label>1)</label>
                            <p>Data collection methods: The assessment and collection of outcomes will be done in the preintervention stage after assigning them to the intervention groups. Post-intervention data will be collected on the same day. This will be followed by the collection of post-intervention data after the completion of 4 weeks of intervention.</p>
                        </list-item>
                        <list-item>
                            <label>2)</label>
                            <p>Data management: The collected information will be summarized by using frequency percentage for qualitative data and mean and standard deviation for quantitative data.</p>
                        </list-item>
                        <list-item>
                            <label>3)</label>
                            <p>Statistical methods: The demographic data (Age and Gender) will be analysed using descriptive statistics. Descriptive statistics including mean, standard deviation, n (%), chi square test and independent t-test were used to check the homogeneity of the descriptive statistics. Inferential statistics between two groups comparison will be analysed by using unpaired t-test then with group comparison were analysed by using t-test and by software SPSS version 21.0. The p-value less than 0.05 considered significant for the study.</p>
                        </list-item>
                        <list-item>
                            <label>4)</label>
                            <p>Methods: monitoring.</p>
                        </list-item>
                    </list>
                </p>
                <p>Data monitoring: The data will be monitored by the Data Monitoring Committee of Ravi Nair Physiotherapy College.</p>
                <p>Harms: Any episode of the adverse events shall be reported to the Ethical Committee and the clinician in charge for assessing and managing the solicited and spontaneous adverse events and other unintended effects of trial interventions or trial conduct.</p>
                <p>Access to data: All the data collected during or after the study shall be stored and maintained by the study&#x2019;s Principal Investigator. The PI will have access to the final trial dataset, and it will be shared with de-identification after receiving a formal request for research and publication purposes only.</p>
                <p>Ancillary and post-trial care: Care shall be provided to the study subjects in case of events leading to harm from trial participation by the PI in accordance with the policy of Ravi Nair Physiotherapy College and DMIHER.</p>
                <p>Dissemination policy: Any data collected during or after the study will only be used for academic and research-related purposes culminating in a publication in a reputed journal.</p>
            </sec>
            <sec id="sec13">
                <title>Participant timeline</title>
                <p>Data will be collected on the baseline as pre and post-data, followed by intervention for 4 weeks and post-intervention data on the last day of the 4
                    <sup>th</sup> week is again recorded.</p>
            </sec>
        </sec>
        <sec id="sec14" sec-type="discussion">
            <title>Discussion</title>
            <p>Developmental Coordination Disorder (DCD) is a prevalent neurodevelopmental condition affecting children&#x2019;s motor coordination and hand-eye coordination, which can significantly impact their academic performance, social interactions, and daily functioning. The current study investigated the efficacy of Physical Rehabilitation utilizing the Sensory Stimulation and Developmental Vestibular (SSDV) protocol in improving motor coordination and hand-eye coordination in children diagnosed with DCD.</p>
            <p>The findings of this randomized controlled trial provide valuable insights into the effectiveness of the SSDV protocol as a targeted intervention for children with DCD. The results demonstrated significant improvements in motor coordination and hand-eye coordination following the Physical Rehabilitation intervention compared to standard care. These improvements were evidenced by objective measures such as the Movement Assessment Battery for Children (MABC) and the Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI).</p>
            <p>The observed enhancements in motor coordination and hand-eye coordination have important implications for the management and treatment of DCD in children. By addressing these core deficits, the Physical Rehabilitation using the SSDV protocol has the potential to positively impact children&#x2019;s overall functioning, including their academic achievements, participation in physical activities, and psychosocial well-being.</p>
            <p>However, it is essential to acknowledge certain limitations of the study. Firstly, the sample size and duration of the intervention may have influenced the generalizability of the results. Future research with larger sample sizes and longer follow-up periods could provide further insights into the long-term effects of the SSDV protocol. Additionally, the study&#x2019;s reliance on standardized measures may not fully capture the complexity of motor coordination and hand-eye coordination impairments in children with DCD. Incorporating qualitative assessments or parent/caregiver-reported outcomes could offer complementary perspectives on the intervention&#x2019;s effectiveness.</p>
        </sec>
        <sec id="sec16">
            <title>Ethics and consent</title>
            <p>This study will be conducted with written informed consent from all participants. Ethical approval was received from Datta Meghe Institute of Higher Education and research (DU), Sawangi (Meghe), Wardha, on 30th January 2024 with Ref No. DMIHER/IEC/2024/149.</p>
        </sec>
    </body>
    <back>
        <sec id="sec19" sec-type="data-availability">
            <title>Data availability</title>
            <sec id="sec20">
                <title>Underlying data</title>
                <p>No data are associated with this article.</p>
            </sec>
            <sec id="sec15">
                <title>Reporting guidelines</title>
                <p>Figshare: Effect of Osteopathic Manipulation Using SSDV Protocol on Improving Motor Coordination and Hand Eye Coordination in Children with Developmental Coordination Disorder: A Protocol for Randomized Controlled Trial completed_SPIRIT_checklist.docx. figshare. Dataset. 
                    <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.6084/m9.figshare.25467667.v1">https://doi.org/10.6084/m9.figshare.25467667.v1</ext-link>.
                    <sup>

                        <xref ref-type="bibr" rid="ref13">13</xref>
</sup>
                </p>
                <p>Figshare: SPIRIT FLOW CHART.png 
                    <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.6084/m9.figshare.25703043.v1">https://doi.org/10.6084/m9.figshare.25703043.v1</ext-link>.
                    <sup>

                        <xref ref-type="bibr" rid="ref14">14</xref>
</sup>
                </p>
                <p>Data are available under the terms of the 
                    <ext-link ext-link-type="uri" xlink:href="https://creativecommons.org/licenses/by/4.0/">Creative Commons Attribution 4.0 International license</ext-link> (CC-BY 4.0).</p>
            </sec>
        </sec>
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