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

Cerebral Palsy, Spastic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03484078
• Other study ID #: STUDY00004873
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 23, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic

Intervention

Device:
• Vibration Platform
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 platform will not vibrate when the participant stands on it 10 minutes per day for 6 months.

Locations

Country	Name	City	State
United States	University of Georgia	Athens	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
University of Georgia	Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fat concentration	Change in fat concentration assessed using imaging techniques	Baseline, 6 months and 12 months
Secondary	Change in muscle size	Change in muscle size assessed using imaging techniques	Baseline, 6 months and 12 months
Secondary	Change in physical activity	Change in physical activity assessed using activity monitors	Baseline, 1 month, 6 months, 7 months, and 12 months
Secondary	Change in dynamic balance	Change in dynamic balance assessed using step recovery method	Baseline, 1 month, 6 months, 7 months, and 12 months
Secondary	Change in static balance	Change in static balance assessed using force plates	Baseline, 1 month, 6 months, 7 months, and 12 months