Effects of Dynamic Flex Cast With Neurodevelopmental Treatment on Gross Motor Functions in Cerebral Palsy

Study Overview
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Brief Summary
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The study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy.

Detailed Description
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The study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy. Combination of Dynamic flex cast with neurodevelopmental treatment will be a novel potential treatment to improve gross motor functions in cerebral palsy. We shall try to fill the gaps of previous studies. It will help in facilitating children to perform their activities, restoring normal ranges and treatment of spasticity in cerebral palsy.

Official Title
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Effects of Dynamic Flex Cast With Neurodevelopmental Treatment on Gross Motor Functions in Children With Cerebral Palsy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: Dynamic flex cast with neurodevelopmental treatment
* Other: Rigid Ankle foot Orthosis with neurodevelopmental treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with cerebral palsy Age 3-8 years Spastic diplegic/ hemiplegic CP Ankle dorsiflexion 5-10 degrees GMFCS level 1-3 Modified Ashworth's scale level 1+ - 3 Exclusion Criteria: Congenital foot deformities Cognitive impairments Secondary orthopedic, auditory and severe visual impairments Unwilling patients or parents Recent surgical interventions

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic flex cast with neurodevelopmental Group<br>Dynamic flex cast with neurodevelopmental treatment | Other: Dynamic flex cast with neurodevelopmental treatment<br>* Neurodevelopmental therapy in combination with dynamic flex cast to treat experimental group. Three times a week, 1 hour session per day. Dynamic flex casting is casting which manipulate bone alignment and maintains range of motion or sustained stretch. Casting will be changed weekly for 3 months. Neuro developmental approach is individualized treatment which is attuned to each child's specific problems, aims and goals. Key elements in NDT are: facilitation (using sensory inputs to improve motor performance), management of compensatory motor behavior, and an overall management strategy (a 24-hour interdisciplinary management approach) NDT involves task specific postures and movements.<br>|
| Active Comparator: Rigid Ankle foot Orthosis with neurodevelopmental Group<br>Rigid Ankle foot Orthosis with neurodevelopmental treatment | Other: Rigid Ankle foot Orthosis with neurodevelopmental treatment<br>* Rigid ankle foot orthosis will be applied to ankle joint at the start of intervention. Neurodevelopmental treatment will be applied to both groups with protocol; Three times a week, 1 hour session per day. Assessment on 1st day,6th week and 12th week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross Motor Function Measure-88 | The original GMFM has 88 items each scored on a 4-point ordinal scale of 0 to 3, where 0 indicates that the child does not initiate the task; 1 indicates that the child initiates the task (completes < 10% activity); 2 indicates that the child partially completes the task (completes from 10 to 99% of activity); 3 indicates that the child completes the task (100%); and NT indicates that the child was not tested. The 88 items are grouped into five dimensions: 1) lying and rolling, 2) sitting, 3) crawling and kneeling, 4) standing, and 5) walking, running and jumping. Reliability with intraclass correlation coeffcient greater than .98 with 0.965--.994 95% confidence interval. | 12 weeks | 
| Clinical Gait Assessment Scale | It is used to assess gait deviation. Temporal distance factors including velocity, cadence, stride length, stride width will be assessed. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankle joint, Cerebral Palsy, Spasticity, Dynamic cast