NCT03484078

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: University of Georgia · Academic / Other
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Palsy, Spastic

Interventions

Type	Name	Description
DEVICE	Vibration Platform	The vibration platform will emit a mild vibration when the participant stands on it 10 minutes per day for 6 months.
DEVICE	Placebo Platform	The placebo platform will not vibrate when the participant stands on it 10 minutes per day for 6 months.

Timeline

• Start date: 2019-01-23
• Primary completion: 2024-03-01
• Completion: 2026-01-30
• First posted: 2018-03-30
• Last updated: 2025-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study