Whole Body Vibration in Children With Cerebral Palsy

Study Overview
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Brief Summary
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Some positive effects of whole body vibration applications in reducing spasticity, improving walking ability, and increasing walking speed have been reported in children with CP, but the evidence is not strong enough. Therefore, this study was planned to evaluate the effect of whole body vibration treatment on spasticity, gait, balance, and motor performance in children with spastic CP. This study hypothesis that whole body vibration provides an additive improvement on spasticity, balance, gait and motor performance.

Detailed Description
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Participants will be evaluate at baseline, after the conventional physiotherapy program, and after whole body vibration training program. During this period, the participants who were recruited whole body vibration training program, whole body vibration will be applied in addition to conventional physiotherapy sessions comprised 45 min, 2 days a week, during 8 week.

Official Title
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The Effect of Whole Body Vibration on Walking Parameters in Children With Cerebral Palsy

Conditions
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Cerebral Palsy, Spastic

Intervention / Treatment
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* Other: conventional physiotherapy program
* Other: whole body vibration training program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children diagnosed with spastic diplegic CP in GMFCS levels I and II, CFCS level I and MACS levels I and II Aged 6-17 years Ability to cooperate with the evaluations Walking independently with or without an orthosis (without any support) Exclusion Criteria: Having a recent injury affecting the lower extremities Having undergone any surgery or Botulinuim Toxin application within the last six months Having severe cardiopulmonary or systemic problems Having uncontrolled seizures, visual or hearing problems preventing the evaluations

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>The participants in the control group will be attended to conventional physiotherapy program. | Other: conventional physiotherapy program<br>* The conventional physiotherapy program consists of stretching exercises for lower extremities, strength exercises for core, upper, and lower extremity muscles, sit to stand exercises, and balance exercises.<br>|
| Experimental: study group<br>The participants in the study group will be attended to whole body vibration training program. | Other: whole body vibration training program<br>* The whole body vibration training program sessions consisted of three 3-min bouts of vibration of 20 Hz and a peak-to-peak amplitude of 2mm with a 3-min rest in between, in addition to conventional physiotherapy exercises for children with cerebral palsy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform. | Gait analysis will be performed without any shoes and assistive devices. Walking evaluation on the gait platform will be limited to 1 minute. Obtained data about step length will be collected as centimeters from the entire 1-minute walk will use for analysis. | Change from baseline step length at 2 months. | 
| Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform. | Gait analysis will be performed without any shoes and assistive devices. Walking evaluation on the gait platform will be limited to 1 minute. Obtained data about stride length will be collected as centimeters from the entire 1-minute walk will use for analysis. | Change from baseline stride length at 2 months. | 
| Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform. | Gait analysis will be performed without any shoes and assistive devices. Walking evaluation on the gait platform will be limited to 1 minute. Obtained data about step width will be collected as centimeters from the entire 1-minute walk will use for analysis. | Change from baseline step width at 2 months. | 
| Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform. | Gait analysis will be performed without any shoes and assistive devices. Walking evaluation on the gait platform will be limited to 1 minute. Obtained dataabout step time will be collected as seconds from the entire 1-minute walk will use for analysis. | Change from baseline step time at 2 months. | 
| Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform. | Gait analysis will be performed without any shoes and assistive devices. Walking evaluation on the gait platform will be limited to 1 minute. Obtained data about cadence will be collected as counts of steps from the entire 1-minute walk will use for analysis. | Change from baseline cadance at 2 months. | 
| Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform. | Gait analysis will be performed without any shoes and assistive devices. Walking evaluation on the gait platform will be limited to 1 minute. Obtained data about velocity will be collected as meters/seconds from the entire 1-minute walk will use for analysis. | Change from baseline velocity at 2 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Pediatric Balance Scale will be used to measure functional balance of the participants. | Scale consist of 14-item. The highest score that can be obtained from the scale is 56. Highest scores shows better balance skills. | Change from baseline score at 2 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy, whole body vibration, gait, balance