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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-23

Study Completion Date

2026-01-30

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.

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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.

Conditions

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Cerebral Palsy, Spastic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Children with CP will be randomly assigned to a vibration or a placebo group.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vibration Platform

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.

Group Type EXPERIMENTAL

Vibration Platform

Intervention Type DEVICE

The vibration platform will emit a mild vibration when the participant stands on it 10 minutes per day for 6 months.

Placebo Platform

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.

Group Type PLACEBO_COMPARATOR

Placebo Platform

Intervention Type DEVICE

The placebo platform will not vibrate when the participant stands on it 10 minutes per day for 6 months.

Interventions

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Vibration Platform

The vibration platform will emit a mild vibration when the participant stands on it 10 minutes per day for 6 months.

Intervention Type DEVICE

Placebo Platform

The placebo platform will not vibrate when the participant stands on it 10 minutes per day for 6 months.

Intervention Type DEVICE

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

Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No