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

Not Applicable

Active, not recruiting

• Conditions: Cerebral Palsy, Spastic
• Interventions: Device: Vibration Platform; Device: Placebo Platform

• Registration Number: NCT03484078
• Lead Sponsor: University of Georgia

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-30
• Study Start: 2019-01-23
• Primary Completion: 2024-03-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vibration Platform	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.
Placebo Platform	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.

Primary Outcome Measures

Name	Time	Method
Change in fat concentration	Baseline, 6 months and 12 months	Change in fat concentration assessed using imaging techniques

Secondary Outcome Measures

Name	Time	Method
Change in physical activity	Baseline, 1 month, 6 months, 7 months, and 12 months	Change in physical activity assessed using activity monitors
Change in muscle size	Baseline, 6 months and 12 months	Change in muscle size assessed using imaging techniques
Change in static balance	Baseline, 1 month, 6 months, 7 months, and 12 months	Change in static balance assessed using force plates
Change in dynamic balance	Baseline, 1 month, 6 months, 7 months, and 12 months	Change in dynamic balance assessed using step recovery method

Trial Locations

Locations (1)

University of Georgia; 🇺🇸 Athens, Georgia, United States