Keywords
dynamic neuromuscular stabilization, neurodevelopmental techniques, proprioceptive neuromuscular facilitation, subacute stroke, trunk control, balance, gait parameters, core stability
This article is included in the Datta Meghe Institute of Higher Education and Research collection.
Today, stroke is the principal cause of demise in both developed and developing countries. There are different techniques used to treat patients with sub-acute stroke. Trunk muscles play a key role, i.e. in keeping the spine and trunk in place. This stabilization requires moving the head and extremities freely and selectively. The aim of this study is to compare the effectiveness of dynamic neuromuscular stabilization (DNS), neurodevelopmental techniques (NDT) and proprioceptive neuromuscular facilitation (PNF) on trunk and gait parameters in the subacute phase of stroke. This study is intended to ascertain the efficacy of all three approaches individually and to compare the effectiveness of DNS, NDT and PNF on trunk and gait parameters. Furthermore, the findings of this study could be used to assist post-stroke survivors in their early recovery and improve their level of independence.
In this interventional study, participants will be divided into three groups, and in each group, 20 patients will be assigned randomly to each group using the sequentially numbered opaque sealed envelope method. Group A patients will be given DNS, Group B will be given NDT, and Group C will be given PNF. The patients will be given treatment for five days for four consecutive weeks. Outcome measures that will be used are trunk impairment scale (TIS), dynamic gait index (DGI) and gait parameters. Data will be collected before and after the 4-week treatment period.
After the study, a conclusion will be drawn regarding which treatment technique is most suitable among all the three strategies for treating stroke patients if the hypothesis of the study is found valid.
Clinical Trials Registry – India (CTRI) reference no. CTRI/2022/06/043037; date of registration 22/05/2022.
dynamic neuromuscular stabilization, neurodevelopmental techniques, proprioceptive neuromuscular facilitation, subacute stroke, trunk control, balance, gait parameters, core stability
Today, stroke is the foremost cause of death in both developed and emerging countries.1 The World Health Organization currently defines stroke as being characterized by rapidly emerging neurological signs of localized (and global) deterioration of neurological function persisting over 24 hours or resulting in death, having no apparent cause beyond an internal circulatory source (defined in 1970 and still used).2 As per a recent analysis primarily based on cross-sectional studies, it is estimated that in India stroke incidence ranges between 105 and 152/100,000 people per year.3 Following an acute ischemic stroke (AIS), the blood brain barrier (BBB) passes through many hemodynamic phases. An increase in permeability (BBBP) could lead to unfavorable consequences like haemorrhagic transformation (HT) on the one hand or increased neoangiogenesis, enabling the entry of potential therapeutic agents on the other hand. Different hemodynamic phases and processes accompany stroke, leading to distinct pathological responses. These phases include hyperacute (less than six hours), acute (6–72 hours), subacute (more than 72 hours), and chronic phase (more than four weeks), with frequently divergent clinical outcomes that must be addressed.4 In cerebrovascular accident (CVA), there is decreased cerebral blood flow (CBF), which can impair neurological function, and lead to sparse oxygen distribution and glucose, starting the stroke pathophysiology cascade.5 After the stroke, if the clinical features last for two weeks, then it is called the acute stage or initial phase of stroke; if it lasts more than two weeks and the condition remains the same for up to six months, then it is called the sub-acute phase; if it lasts six months to years then it is called the chronic phase of stroke.6 An important predicting factor in the admitted patient is maintaining balance while sitting and performing the activity of daily living (ADLs) such as eating, toilet utilization, movement, self-hygiene, bathing, getting dressed, and bladder and bowel control.7 Changes in trunk position awareness and muscular weakening in stroke patients mostly impact balance problems.8 Trunk muscles play an important role, i.e., keeping the spine and trunk in place. This stabilization requires moving the head and extremities freely and selectively.7 Walking dysfunction is a significant problem for many subjects affected by stroke. This makes it difficult to carry out daily tasks.9 If not addressed early in the rehabilitation process, gait asymmetry can be prolonged and worsen gait impairment.10 Bobath, Brunnstrom, Coulter, Clayton, Fay, Kabat, Knott and Rood, Voss, and Kolar are some of the physiotherapeutic approaches available. As a result, stroke rehabilitation should be cost-effective and, on the contrary, stroke rehabilitation appears to be preferable to spontaneous recovery.11
Dynamic neuromuscular stabilization (DNS) is a new rehabilitation concept developed by Professor Pavel Kolar after being inspired by Vojta’s reflex locomotion.12
Principles of DNS: The exact simultaneous contraction of the multiple muscles of the spine creates the integrated spinal stabilization system (ISSS), which includes the cervical extensors and flexors, diaphragm, transverses abdominis muscle, pelvic floor and multifidus. This concept is based on developmental kinesiology, which emphasizes the presence of star movement patterns at birth.12,13
NDT-Bobath intervention is widely used to treat stroke. These are not the particular set of exercises, but the 24h × 7 days a week principle-oriented neuro rehabilitation, in which proper patterns and stimulation are made in a care-based manner, and the optimal usage of the patient’s brain neuroplasticity, avoidance of compensatory mechanisms, and the patient’s maximal independence in everyday activities.1,14
According to Kabat, proprioceptive neuromuscular facilitation (PNF) is a technique which works based on the concept that increased voluntary responses are achieved when movement patterns are combined with other facilitative processes. In investigations of both subacute and chronic stroke, PNF intervention has been documented.7,15
There is a need to study and compare the utility of the external feedback-based approach, neurodevelopmental treatment (NDT) and proprioceptive neuromuscular facilitation (PNF) on trunk and gait function in stroke. This study tries to find the effect of an internal feedback-based approach (dynamic neuromuscular stabilization), which emphasizes the patient’s awareness of muscle activation by the intrinsic mechanism involving proprioception. The external feedback-based approaches, NDT and PNF utilize extrinsic feedback of the therapist to activate their muscles for improving the trunk and gait function in stroke. DNS assumes that core stability and basic extremity locomotion function are under central nervous system (CNS) control. It implies specific co-activation of the intrinsic muscles of the spine, which brings all joints in a functionally centrated position and provides a mechanical advantage for the best possible joint mobility throughout the range.
This study is an interventional study with three arm parallel groups, randomized clinical trial; the study has been registered with the CTRI Clinical Trials Registry – India (CTRI) reference no. CTRI/2022/06/043037. Twenty patients will be assigned to each group (n = 60).
This study protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist (Figure 1).16 Patients will be selected from the inpatient department (IPD) of the Acharya Vinoba Bhave Rural Hospital, Sawangi, (Meghe), Wardha, Maharashtra and from the Ravi Nair Physiotherapy College (OPD) outpatient department for the study purpose. A printed form in the participant’s native language i.e. Marathi, Hindi and English for approval from participants with a signature will be taken by the principal investigator. Then, subjects will be assessed based on inclusion and exclusion criteria.17
Inclusion criteria
• Both males and females between the ages of 40 and 65 years.
• Subjects with sub-acute phase of stroke.
• Those who have hemiparesis or hemiplegia as a result of a single stroke.
• Those that can comprehend and follows instructions.
• Patients who gave consent to be a part of the research.
Exclusion criteria
• Those who have had a transient ischemic attack before.
• Those who have a history of recurrent strokes.
• Those who have a joint or muscular dysfunction that is not caused by a stroke.
• Those who have a physician-determined unstable cardiovascular condition.
• Patients who are enrolled in a different clinical trial.
Group A: DNS
Subjects in this group will receive combined therapy of DNS and conventional physiotherapy, which will include trunk, pelvis and lower limb training. Conventional exercises include the active range of motion (ROM) exercises, stretching of the tightened muscles, mat exercises for stability, functional training for ADL.18 DNS includes a few developmental pattern exercises that involve the therapist positioning their thumbs on the chest area and encouraging regular breathing patterns while supporting the descent of the diaphragm to engage its stabilizing function. The DNS treatment is as follows: the protocol consists of 12 developmental pattern exercises that involve reflex-mediated diaphragm facilitation and the therapist using their thumb to hold its decent. This activates the core stabilizers by positioning the vertebral column, ribcage, pelvis, and scapula in position. For the first week, three developmental positions will be implemented to teach an appropriate breathing pattern and stabilization, and for the next three weeks, new three to four patterns from the DNS posters will be instructed. By the end of the fourth week, the participants will have to be able to successfully practice all the patterns illustrated on the DNS poster19: diaphragmatic breathing, three-month supine position with hips, knees and ankles at 90-degree flexion. Prone 3-month position with upper arms at a 90-degree angle to the trunk, support on elbows. Side lying, 5th-month position patient lying on the side, lower shoulder (support) and elbow will be flexed wrist in the neutral position. The lower limb is supported in a semi-flexed position at the knee, aligning the heel and hip with the ischial tuberosity. In seventh month of oblique sitting, the patient will be positioned on their side with their forearm, hand, hip, thigh, and ankle in alignment and the quadruped position.20 The patient will be placed on all fours, knees directly under the hips and hands and wrists directly under the shoulders. Patients in this group will undergo 45 minutes of trunk and pelvis and lower limb exercises followed by 10 minutes of relaxation period in-between the treatment and 15 minutes of conventional exercises excluding relaxation time for five days per week for four weeks.
Group B: NDT
Subjects in this group will receive combined therapy of NDT and conventional physiotherapy which aim at trunk, pelvis and lower limb training. Conventional Exercises include the Active ROM exercises, stretching of the tightened muscles, MAT exercises for stability, functional training for ADL.18 A therapy program will be applied to the patients depending of the functional level in these will be: Latissimus dorsi muscle stretching, latissimus dorsi functional utilization and strengthening, performing to enhance the functional strength of abdominal and oblique muscles, arranging routines to assist in trunk extension, rotations, and counter-rotations (both to the right and left of the hips with an extended trunk, training the stabilizing muscles of the lumbar spine, and practicing functional reaching movements for the shoulders, both in front and to the sides.21 Participants in this group will perform 45 minutes of NDT with 15 minutes of conventional physiotherapy (Total one hour per day), five days a week for four weeks. Total one hour excluding the relaxation time of 10 minutes.
Group C: PNF
Individuals in this will undergo combined therapy of PNF and conventional physiotherapy, including trunk, pelvis, and lower limb training. For upper and lower extremity: D1 and D2 flexion and extension patterns using PNF principles. It will be progressed to active assisted motions, active resisted actions, and eventually active activities. And for trunk Rhythmic stabilization and alternating isometrics.22 Pelvic PNF Patterns of movement will be performed which are anterior elevation, posterior depression, posterior elevation and anterior depression by rhythmic initiation and repeated contraction of the hemiplegic side.23 The treatment will incorporate PNF elements, including positioning, manual contact, resistance and verbal commands. Study techniques such as rhythmic initiation, slow reversal, agonist reversals will be used.24 Patients in the group will undergo 45 minutes of pelvis, trunk and lower limb exercises on the involved side, followed by 10 minutes of relaxation and then 15 minutes of conventional exercise per day, a total of one hour excluding relaxation time. This will be for five days per week for four weeks.
Criteria for discontinuing the interventions
If patient feels any discomfort during the treatment or because of the treatment, then health providers will be called immediately, the treatment will be discontinued, and the patient will be requested to withdraw his or her consent from the procedure if they no longer wish to proceed.
Relevant concomitant care
The patient will be allowed to take physician prescribed drugs if there are any co-morbidities.
Outcome measures will be taken on the first day and at the end of the four-week treatment. The assessor who is aware of the outcome measures and has similar experience to the physiotherapy resident conducting the study will take pre- and post-outcome measures using TIS, DGI and Gait parameters.
• Trunk impairment scale helps measure motor impairment after a stroke. The TIS helps to determine dynamic sitting and static sitting balance and coordination of the trunk. It has three subscales for the evaluation of static, dynamic and coordination of the trunk. Intra-observer and inter-observer reliability is excellent, with a test/retest reliability coefficient (ICC) of 0.96 and inter-observer reliability coefficient of 0.99 for the TIS total score.
• Dynamic gait index assesses the patient’s balance and fall risk. This instrument serves as a means to assess gait and balance, and the likelihood of experiencing a fall. On this scale, the capacity to keep one’s balance while walking in the presence of outside pressures is tested. The reliability is 0.97, and the validity is 0.83.
• Gait parameters The primary variables to consider while evaluating walking are stride length, cadence, and gait velocity. The distance between two consecutive foot placements, or a stride, is equal to two step lengths. The number of steps taken over a certain period of time are measured by cadence. The 10-meter walk test evaluates walking speed over a short distance in meters per second.
This study design will involve three independent groups to investigate the efficacy of DNS, NDT, and PNF in trunk and lower limb, for trunk control, balance and gait parameters. Sixty subjects will be assigned to the study (20 participants in Group A, Group B and Group C).3 Six additional participants will be recruited in the event of dropout or a problem with data compilation, preserving the sample size. As a conservative estimate, we expect 66 subjects to complete the study (dropout rate = 25%).25
Where,
Z α/2 is the level of significance at 5% i.e., 95 %.
Confidence interval is = 1.96
P = Prevalence of Stroke is = 2.6% = 0.0026
A computer-generated number will be used for randomization, and patients will be assigned to three groups using the sequentially numbered opaque sealed envelope (SNOSE) method. Group A will receive DNS along with conventional exercises, Group B will be given NDT along with traditional exercises, and Group C will be given PNF along with conventional exercises targeting the trunk, pelvis and lower limbs. The principal investigator and the research coordinator will supervise the randomization of the participants. The study will be supervised by the postgraduate advisor, department head, principal, and research team advisor.
For the treatment, the assessor will be blinded. Unblinding can occur in an emergency where a participant’s medical care and safety are a concern. It will be done by the principal investigator, who has access to the data along with the permission of the ethical committee and the proper documentation for the reason for unblinding.
The evaluation data will be obtained pre-treatment with variable baseline characteristics. Research data will be placed in a secure database. Non-electronic documents, including signed informed consent forms and hard copies of evaluation forms, will be securely kept within the study setting under the supervision of principal investigator.
SPSS version 27.0 will be used for conducting statistical analysis. The mean and SD will be subjected to normality test using Kolmogrov Smirnoff test. The outcomes of inferential statistics will be presented in a tabular format and subjected to testing at a 5% significance level (p<0.05). The variables – trunk impairment scale, dynamic gait index and gait parameters will be analyzed using a student’s paired t-test and Wilcoxon signed rank test to compare pre and post intervention results within the group. For the comparison of variables between the groups, a one-way ANOVA test, Kruskal Wallis test, and multiple comparison test will be used.
A team committed to monitoring and combining the data will be established. The entire process will be supervised by clinicians and the departmental committee, which includes the guide, the head of the department, the principal, and members of the research guideline team. An auditing trial will be executed each month. Any deviance from the standard procedure will be recorded and will be addressed accordingly. The completed dataset will be made available to relevant authorities and uploaded to the institutional research website.
Research ethics approval
The study has been approved by the Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (Deemed to be a University) DMIMS (DU)/IEC/2022/898 on 11th April 2022 for patients diagnosed with sub-acute stroke. The study is registered with the Clinical Trials Registry – India (CTRI) reference no. CTRI/2022/06/043037; date of registration 22/05/2022.
Consent
The therapist will orient patients about the study and goals, and approaches before any patients are accepted. Written informed consent forms will be signed by the patients of subacute stroke before commencement of the study.
Confidentiality
The study procedure will be explained to the patients and the principal investigator will obtain written informed consent. With the full guarantee of the patient’s confidentiality, agreement will be obtained from the patient if disclosure of certain information is necessary for the study.
It is unlikely that the participants will experience any negative effects from the assigned interventions. In the event that harm occurs, patients will be offered free in- or outpatient therapy as determined by an expert assessment at the completion of the four-week intervention.
The principal investigator will have the right to access the data. The principal investigator will store data in the DMIHER data repository after the study is finished, and the results are published.
We intend to investigate the effects of the three approaches i.e. DNS, NDT, PNF on trunk control and gait parameters in individuals suffering from sub-acute stroke. The aim of this research is to ascertain the efficacy of these approaches and to compare these approaches in improving trunk control, balance and gait in stroke using TIS, DGI, and gait parameters as outcome measures. Trunk and pelvic control are vital for stability and locomotion in humans. Hemiplegic stroke impairs trunk function multi-directionally.
A study was carried out by Raghuveer et al., in 2021 to ascertain the impact of NDT and DNS approaches on hemiplegics with impaired trunk strength, through diaphragm activation. A reflex-mediated diaphragmatic activation of core muscle, DNS, is done in patients with hemiplegia and was found to be more effective in functional improvement in the trunk than NDT.19 Similarly, Sharma et al., in 2020, co-activated the ISSS in all segments as a complete technique in treating any case and proved it is very effective in different neurological or musculoskeletal cases.12 Son and You et al., in 2017, demonstrated EMG research revealed that hemiparetic stroke victims had increased activation of the inner core TrA/IO muscles in DNS. DNS may have stimulated hemiparetic individuals’ underactive deep core TrA/IO muscles.26 In 2017 research was conducted to see the effect of strengthening the core combined with pelvic PNF in chronic stroke patients with trunk, balance, gait, and functional ability impairment. The patients were given strengthening of core combined with pelvic PNF and flexibility exercises of trunk muscles along with PNF. In chronic stroke patients, core stability exercises and pelvic PNF were more successful in reducing trunk dysfunction, balance, and gait.24 Kim et al. (2018) aimed to determine and achieve balance and walking competency of post-stroke patients when applying PNF for pelvic and lower extremity PNF using treadmills; they found a difference in the balance capability of post-stroke patients.27
There is a shortage in the literature comparing these three treatment approaches over trunk and gait parameters. There is a strong need to conduct a study to compare these approaches. Furthermore, the findings of this research could be used to assist post-stroke survivors in their early recovery and improve their level of independence.
Zenodo: Extended data for ‘Effectiveness of dynamic neuromuscular stabilization, neurodevelopmental techniques and proprioceptive neuromuscular facilitation on trunk and gait parameters in patients with subacute stroke: A three-arm parallel randomised clinical trial’, https://www.doi.org/10.5281/zenodo.10143795. 17
Zenodo: SPIRIT checklist for ‘Effectiveness of dynamic neuromuscular stabilization, neurodevelopmental techniques and proprioceptive neuromuscular facilitation on trunk and gait parameters in patients with subacute stroke: A three-arm parallel randomised clinical trial’, https://www.doi.org/10.5281/zenodo.10089270. 16
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).
I am grateful to Mr. Laxmikant Umate who helped with the sample size calculation for the study.
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Is the rationale for, and objectives of, the study clearly described?
Yes
Is the study design appropriate for the research question?
Yes
Are sufficient details of the methods provided to allow replication by others?
Yes
Are the datasets clearly presented in a useable and accessible format?
Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Neurological Rehabilitation; Health Professions Education
Is the rationale for, and objectives of, the study clearly described?
Yes
Is the study design appropriate for the research question?
Yes
Are sufficient details of the methods provided to allow replication by others?
Yes
Are the datasets clearly presented in a useable and accessible format?
Yes
References
1. Tressoldi PE, Storm L: Stage 2 Registered Report: Anomalous perception in a Ganzfeld condition - A meta-analysis of more than 40 years investigation.F1000Res. 2021; 10: 234 PubMed Abstract | Publisher Full TextCompeting Interests: No competing interests were disclosed.
Reviewer Expertise: Physiotherapy
Alongside their report, reviewers assign a status to the article:
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