Effect of Vibration on Muscle Properties, Physical Activity and Balance in Children With Cerebral Palsy

Study Overview
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Brief Summary
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The aim of the 6-month randomized controlled trial, with 6-month no treatment follow-up, is to examine the effects of low-magnitude vibration on muscle, physical activity, and balance in children with spastic cerebral palsy.

Detailed Description
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Cerebral palsy (CP) is a movement disorder that affects over 800,000 people in the U.S. Due to the limited mobility associated with the disorder, individuals with CP have an increased risk of chronic diseases, such as cardiovascular disease, diabetes mellitus and osteoporosis, compared to the general population. Therefore, identifying treatment strategies is of utmost importance. The aim of this study is to examine the acute and chronic effects of low-magnitude vibration on muscle, physical activity, and balance in children with CP. Fat concentration and muscle will be assessed using imaging techniques. Physical activity will be assessed using activity monitors. Balance will be assessed using clinical and biomechanical tests. Children with CP will be tested at five time points: baseline, 1 and 6 months after standing on a vibration platform daily 10 minutes per day, 1 and 6 months post treatment (7 months and 12 months from baseline, respectively). The findings from the proposed study will help us determine if vibration shows promise as a treatment for the impaired mobility, lower physical activity and higher risk of chronic disease in individuals with CP.

Official Title
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Effect of Vibration on Muscle Properties, Physical Activity and Balance in Children With Cerebral Palsy

Conditions
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Cerebral Palsy, Spastic

Intervention / Treatment
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* Device: Vibration Platform
* Device: Placebo Platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spastic cerebral palsy Independent ambulator without an assistive device (Gross Motor Function Classification System level I or II) Exclusion Criteria: Prior fractures in both femurs or tibias Currently taking bisphosphonates Unable to stand independently Orthopedic surgery on a lower extremity within the last 6 months Children with pure athetoid CP Baclofen pump in the abdomen Botox treatment within the last year

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 11 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
Interventional Model Description: Children with CP will be randomly assigned to a vibration or a placebo group.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibration Platform<br>The vibration group will stand on a platform that emits a mild vibration 10 minutes per day for 6 months. There will also be a 6 month no-treatment period. | Device: Vibration Platform<br>* The vibration platform will emit a mild vibration when the participant stands on it 10 minutes per day for 6 months.<br>|
| Placebo Comparator: Placebo Platform<br>The placebo group will stand on a placebo platform 10 minutes per day for 6 months. There will also be a 6 month no-treatment period. | Device: Placebo Platform<br>* The placebo platform will not vibrate when the participant stands on it 10 minutes per day for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fat concentration | Change in fat concentration assessed using imaging techniques | Baseline, 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle size | Change in muscle size assessed using imaging techniques | Baseline, 6 months and 12 months | 
| Change in physical activity | Change in physical activity assessed using activity monitors | Baseline, 1 month, 6 months, 7 months, and 12 months | 
| Change in dynamic balance | Change in dynamic balance assessed using step recovery method | Baseline, 1 month, 6 months, 7 months, and 12 months | 
| Change in static balance | Change in static balance assessed using force plates | Baseline, 1 month, 6 months, 7 months, and 12 months |