Effect of reflex mediated core stabilization and system-based task-oriented approach on motor function and motor ability in children with developmental delay: protocol for a comparative study

Introduction

When a child fails to reach developmental milestones compared to peers their own age, they are considered to have a developmental delay. A recent study indicated that children in rural settings had a higher rate of developmental impairment (19.8% versus 17.4%).¹ Additionally, children living in rural regions had higher rates of cerebral palsy (0.5%) and Attention Deficit Hyperactivity Disorder (11.4% compared to 9.2%) than children living in urban areas.¹

Based on the domains of impairment, there are three different types of developmental delay: i) isolated (involving one domain), ii) multiple (affecting two or more domains or developmental lines), and iii) global (greatest developmental delays affecting all domains).² Additional classifications for developmental delay include mild (functional age < 33% of chronological age), moderate (functional age 34% to 65% of chronological age), and severe (functional age > 66% of chronological age).³

Although the precise pathophysiology is not well understood, few explanations have been suggested. Epidemiological research demonstrated the role of genes having a key impact on the delay of growth originating in some families. Environmental factors like poverty and severe deprivation, perinatal difficulties also play a part in delaying development, but specific causal connections are still uncertain. Although there are no clear precise cause-and-effect correlations for most illnesses, pregnancy-related psychosocial stressors, maternal immune activation (MIA) and alteration of the hypothalamic-pituitary-adrenal (HPA) were found to have a substantial impact on fetal brain development.⁴

Developmental delay has several impairments including motor impairment, speech impairment and learning impairment. In motor impairment, there is a significant delay in fine and gross motor skills, including stiff muscles, loose trunk and limbs, limited movement in the legs and an inability to bear weight on feet and legs.⁵

There are some standardized developmental screening tools that are identified by the American Academy of Pediatricians (AAP) for evaluation of developmental delay. They include Ages and Stages Questionnaire (screens children’s development), Bayley Infant Neurodevelopmental Screener (neurological impairment), Battelle Developmental Inventory Screening Test (adaptive, 9 personal-social, basic and expressive language, and cognitive skills), Child Development Inventories, Developmental Activities Screening Inventory, Developmental Observation Checklist System, Early Screening Inventory, Early Screening Profile, Learning Accomplishment Profile Diagnostic Screen, McCarthy Screening Test (child ability to cope), and Parents’ Evaluation of Developmental Status.⁶

Primary care professionals collaborate on the management of developmental delay including specialists from pediatrics, neurology, child and adolescent psychiatry, psychology, genetics, occupational therapy, physical therapy, speech and language pathology, nutrition and nurses, hence the therapeutic methods are considered multi-modal.⁴ There are numerous physical therapy approaches such as Proprioceptive Neuromuscular Facilitation (PNF), Neuro-Development Treatment (NDT), Bobath approach, Somatosensory stimulation for activation and inhibition, Mobility Opportunities Via Education (MOVE), Dynamic Neuromuscular Stabilization (DNS) and Task-oriented approach (TOA), which help to improve motor function.⁷

Reflex-mediated core stabilization, also known as dynamic neuromuscular stabilization (DNS), exercises are created using the principles of developmental kinesiology, which examines and utilizes the development of infants’ motor behavior from birth until they can walk.⁸

Newborns throughout their developing process engage in basic movements in a variety of situations like keeping posture against gravity and enhance mobility. When there is a lack of motor development throughout childhood it leads to neuromuscular abnormalities, and because of neuromuscular abnormalities there are biomechanical deficiencies. DNS targets the facilitation of core stability to correct neuromuscular problems. The infant’s neurological and muscular systems require precise cooperation throughout the process in order to defy gravity, maintain posture, and enhance mobility. Reflex-mediated core stabilization diagnoses and treats newborns by utilizing their movement development by recalling motor patterns based on genetic stages.⁹

When it comes to reconditioning functional abilities (such proper sitting, standing and sitting down, transfer skills and stepping), the task-oriented method offers useful guidelines and combines various motor learning theory components. This method focuses on facilitating the growth of active motor control through practice and effective feedback for task-specific learning. Numerous ‘goal-directed’ movements are available depending on the particular task or intended purpose strategies. For instance, managing mobility on uneven or slippery surfaces, the change in topography or whether the surface is dynamic, unstable or immovable may require motor, cognitive and visual skills.¹⁰ An effective task-oriented training is to enhance muscle strength or functionality in individuals with neurological disorders and provide repetitive practices. Task-oriented training gives children engaging tasks in objective functional aspects, and repetitive training in an atmosphere that can stimulate activity and involvement, which may eventually improve motor performance.¹¹

This study will try to find out the effectiveness of reflex-mediated core stabilization and system-based task-oriented approach to improve motor function (Gross Motor Function Measure version 88 (GMFM-88), Gross Motor Function Classification System (GMFCS)) and motor ability (Manual Ability Classification System (MACS)) among children who have delayed development.

Protocol

After getting approval from the Datta Meghe Institute of Higher Education and Research’s ethics council, the study will be carried out at the neuro rehabilitation department of Acharya Vinoba Bhave Rural Hospital and the neuro physical therapy outpatient department at Ravi Nair Physiotherapy College, Sawangi (Meghe) Wardha. Participants who have been identified as having developmental delays and who meet the inclusion criteria will be chosen at random by sequentially numbered, sealed, opaque envelopes and will be divided into either Group A or Group B. The participants will sign a formal consent form after being fully informed about the study methodology. The study will last for a full year. The total number of participants will be 54, each group will consist of 27 individuals in total (refer to sample size calculation). The outcome measures will include GMFM-88,¹² GMFCS¹³ and MACS,¹⁴ which will be used to assess motor function and motor ability. Patients in Group A will be assigned into reflex-mediated core stabilization with conventional therapy and patients in Group B will be assigned into system-based task-oriented approach and conventional therapy. The outcome variable will be assessed at baseline, week two, week four, and after the sixth week (Figure 1). An example of the blank consent form and study proforma can be found as Extended data.²³ This protocol adheres to the SPIRIT checklist.²⁴

Figure 1. Flow chart.

Intervention

Experimental group

Reflex-mediated core stabilization

The physical training sessions given to participants will be functionally oriented and supervised.¹⁵ The exercises utilize reflex-mediated facilitation of core muscles to stabilize trunk and girdles, thereby improving mobility of upper limb and lower limb. The intervention will be given for 40 minutes followed by 20 minutes of conventional therapy six days a week for six weeks⁹ (Table 1).

Table 1. Reflex mediated core stabilization.

This table includes a 9-year boy who is performing all positions and an instructor who is a postgraduate student in physiotherapy. We confirm that we have obtained permission to use images from the caregiver of the participant and the individual included in this presentation.

Position name	Example of position	Instructions	Dosage	Progression
Supine lying		The therapist assists the patient in maintaining a neutral (caudal) position of the chest by gently pushing it caudally (without pressing it against the table); the other hand, placed on the lower abdominal wall, cues the patient to activate the abdominal wall with inhalation and a postural task.	Set 1: 10 repetitions 1 second inhale: 2 second exhale 60-90 second rest period	For the first week, 3 developmental patterns will be used for education of correct breathing
Prone position		By placing one hand on the nuchal line and the other on the mid-thoracic spine, the clinician assists in elongating the spine and aligning the neck in a neutral posture. The clinician instructs the patient to begin cervical extension from this point.		For the first week, 3 developmental patterns will be used for education of correct breathing
Side lying position		- The therapist assists the patient in maintaining a neutral position of the bottom supporting shoulder blade throughout the activity. - The therapist opposes the patient’s top arm reaching movement (forearm supination) and bottom arm supporting action (forearm pronation).	Set 2: 15 repetitions 2 seconds inhale: 4 second exhale 60-90 second rest period	For the first week, 3 developmental patterns will be used for education of correct breathing
Quadri pod position		The therapist assists with knee centration by pressing through the knee towards the supporting foot and restraining the patient's reaching arm.		for next 5 weeks, new three to four patterns were introduced
Tripod position		- Therapist will push the right hand and the left foot down to the and keep the spine as straight as possible at the same time and will do the same on the opposite side. - Squat: The therapist will support and stabilize the patient's posture while directing breathing patterns. After that, the support may be removed and the patient.	Set 3: 20 repetitions 3 second inhale: 6 second exhale 120-150 second rest period	for the next 5 weeks, new three to four patterns were introduced

Control group

System-based task-oriented approach

Task oriented approach concentrates on specific functional movement activities such as tying shoes, throwing an object, and writing. The intervention will be given for 40 minutes followed by 20 minutes of conventional therapy six days a week for six weeks. The actions will be practiced in both sitting and standing and should target an individual’s particular deficits¹⁶ (Table 2).

Table 2. Task oriented approach.

Intervention progression	Week
Rolling, weight bearing from side to side while sitting, movement progression (pushing a ball), lying on one side with swaying back and forth, playing quoits, play around the throwing ball, rolling while lying on physio ball, bouncing while sitting on the physio ball with the help of therapist	0-1 week
Kneel standing position, raise right/left foot front and then stand, pick up the object from the floor in a standing position	1-2 week
Keep balance lying down, sitting and standing on sway ball, weight bearing while holding a bar, walking on balance beam, spinning in one place	2-4 week
Kick the ball rolled by the therapist, walk while crossing the obstacles, joint movement (extensional movement), pulling toward themselves (tug of war, chin up)	4-6 week

Conventional therapy

Conventional therapy will be included in both groups, which will include facilitatory techniques for gross motor control including quadruped, crawling, kneeling, sitting, walking as well as exercises comprising passive stretches for the adductors, hamstrings, quadriceps, and calf muscles in both limbs (three repetitions with a 10-second hold), active and passive range-of-motion exercises for the lower limbs in sitting and supine (three sets with 10 repetitions)¹⁷ (Table 3).

Table 3. Conventional therapy.

Motor impairment	Goal	Physiotherapy intervention
Unable to stand on hands/feet, unable to sit without support	To facilitate trunk control	Quadruped rocking and reaching, assisted crawling, trunk control with the help of therapeutic ball, sliding with support, assisted reach outs
Unable to walk	To facilitate walking	Assisted kneeling, walking with the help of therapeutic ball or wheel walk, weight shifting with assistance
Unable to perform activities like kicking or throwing	To facilitate movements like kicking and throwing	Paddling, manual resistance exercises, sit to stand, multi-dimension reach outs.
Unable to take turn, unable to walk up and downstairs, unable to run	To improve motor functions like stair climbing and running	Treadmill walk with the support of harness, stepping forward reach out, step up and step down, stair climbing assistance
Unable to stand on one foot	To improve balance	Assisted weight shifting, tandem walking, zig-zag walking, trampoline
Unable to balance and coordinate, jump rope etc.	To facilitate balance and coordination	Balance training
No control over body movements and physically more dependent	To improve balance and strength	Strength training (use of therapeutic band, use of weight cuffs)

A participant can leave the study at any time if there are evidence of adverse effects, including muscle soreness, joint pain or any injury.

Intervention protocols will be taught to the mother to improve adherence, including three times daily exercises like stretching of gastrocnemius, hamstring and quadricep muscle and strengthening exercises.

Medication that are relevant for concomitant care will be permitted during the trial, such as botulinum toxin injection, which improves walking ability in children.

Discussion

The objective of the research will be to determine the impact of reflex-mediated core stabilization and system-based task-oriented approach on motor function and motor ability in children with developmental delay. In developmental delay there is a delay in gross motor skills, including stiff muscles, loose trunk and limbs, limited movement in the legs, and an inability to bear weight on feet and/or legs.

Task-oriented techniques emphasize focus on the task or series of tasks to be mastered and rely on the concepts of motor development and learning. In essence, they profit from the notion that the development of skills and knowledge are most powerful when the learner comprehends the purpose of the training and considers the work to be helpful or pertinent to their life.¹⁰ Task-oriented training programs based on Neuromotor Task Training (NTT) principles, delivered in small groups, have a favorable effect on motor function in children who had neurodevelopmental problems, and this benefit was stronger than in the group receiving standard treatment.¹⁷ It may be beneficial to use high variability practice in a task-focused training course as it is an effective way to enhance motor performance skill.¹¹ In a randomized controlled pilot study, analysis of the data revealed that both the core stability exercise and task-oriented training groups significantly improved motor proficiency. This suggests treatment of children with developmental coordination deficit, core stability exercise is just as beneficial as task-oriented motor training.¹⁹

Numerous studies reviewed the effects of dynamic neuromuscular stabilization (DNS) in adults with core instability. However, there is a shortage of clinical data examining the benefits of core stabilization exercises for children with developmental delays. Core stabilization is achieved by using specialized stimulation zones to reconnect the disrupted core stabilization chain and restore the sensory pathways regulating the dynamic neuromuscular core stabilization. This makes it beneficial for individuals with developmental delays who struggle with cognition and attention. Nevertheless, the DNS technique’s therapeutic properties on motor function and motor ability remain unknown in participants with developmental delay.²⁰ Studies of DNS on trunk function in hemiplegia suggest that, when compared to intentional NDT activation in participants with hemiplegia, reflex-mediated diaphragmatic and core muscle activation (DNS) can be more efficient at enhancing trunk performance.²¹ Another study on the effects of dynamic core-postural chain stabilization on diaphragm activity, abdominal muscle thickness, and postural control in patients with subacute stroke, revealed the superiority of DNS over NDT in enhancing gait control and postural movement efficiency.²² Dynamic neuromuscular stabilization greatly enhanced GMFM scores for the domains of standing, moving, and jumping in patients with cerebral palsy as well as their breath control, posture, equilibrium, and gait performance.²⁰

Through this study, the impact of DNS and system-based task-oriented approach on motor function and motor ability will be studied, and comparison will reveal which is the better intervention.