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

University of Georgia (UGA)

Status: Active, not recruiting

Conditions: Cerebral Palsy, Spastic

Treatments: Device: Placebo Platform; Device: Vibration Platform

Study type: Interventional

Funder types: Other

Identifiers

NCT03484078

STUDY00004873

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

Vibration Platform

Experimental group

Description:

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.

Treatment:

Device: Vibration Platform

Placebo Platform

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo Platform