Endermotherapy for Children With Developmental Disabilities

Study Overview
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Brief Summary
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Children with developmental disabilities often sustain decreased range of motion in their extremities. The decrease in flexibility may be due to neuromuscular disorders such as spasticity or dystonia. Other causes may be imbalance in muscle strength surrounding a joint, leading to inappropriate habitual posture. Over time, muscle contracture may result for those muscle groups that are placed in a shortened position for an extended period of time. The most common site of muscle contractures among these children are gastrocnemius/soleus (lower limbs), and latissimus dorsi muscles (upper limbs). Muscle contractures can lead to further decline in functional abilities. Therefore, it is important to identify effective intervention strategies to enhance or maintain muscle flexibility in children with developmental dysfunctions. Commercially available endermotherapy device has been used to soften scar tissue following burn injuries. The mechanical stimulation applied may also have beneficial effects on relaxing the muscle tissue. The overall aim of the proposed study is to determine whether endermotherapy treatment has immediate effect in improving joint range of motion among children with developmental disabilities. The research hypothesis is that children in the endermotherapy group will have significantly more gain in ankle passive range of motion than those in the control group.

Official Title
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Effect of Endermotherapy on Passive Ankle Range of Motion in Children With Developmental Disabilities

Conditions
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Cerebral Palsy, Developmental Delay

Intervention / Treatment
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* Procedure: Endermotherapy
* Procedure: Passive manual stretching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children aged between 2 and 6. children with diagnosis of cerebral palsy or developmental disabilities. Has limited ankle dorsiflexion range of motion (less than 20 degrees) Exclusion Criteria: Other serious illnesses that preclude participation

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endermotherapy<br>The subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist. | Procedure: Endermotherapy<br>* The subjects will receive a single session of endermotherapy applied to the gastrocnemius/soleus muscle on the more affected side for 5 minutes. The treatment will be conducted by a qualified physiotherapist.<br>|
| Active Comparator: Passive stretching<br>The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes. | Procedure: Passive manual stretching<br>* The subjects will receive a single session of passive manual stretching of the gastrocnemius/soleus muscle on the more affected side. The treatment will be given by a qualified physiotherapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle Passive Range of Motion | The ankle passive range of motion will be measured by a Myrin goniometer. | day 1 before treatment | 
| Ankle Passive Range of Motion | Ankle passive range of motion at day 4 before the crossover treatment | day 4 before treatment | 
| Ankle Passive Range of Motion | Ankle dorsiflexion passive range of motion | Day 1 after treatment | 
| Ankle Passive Range of Motion | Ankle passive range of motion on day 4 after the crossover treatment | Day 4 after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flexibility, muscle, stretching, cerebral palsy, developmental