Cerebral Palsy, Spastic
Conditions
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.
Interventions
DEVICEVibration Platform
The vibration platform will emit a mild vibration when the participant stands on it 10 minutes per day for 6 months.
DEVICEPlacebo Platform
The placebo platform will not vibrate when the participant stands on it 10 minutes per day for 6 months.
Sponsors
Emory University
University of Georgia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Children with CP will be randomly assigned to a vibration or a placebo group.
Eligibility
Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fat concentration | Baseline, 6 months and 12 months | Change in fat concentration assessed using imaging techniques |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle size | Baseline, 6 months and 12 months | Change in muscle size assessed using imaging techniques |
| Change in physical activity | Baseline, 1 month, 6 months, 7 months, and 12 months | Change in physical activity assessed using activity monitors |
| Change in dynamic balance | Baseline, 1 month, 6 months, 7 months, and 12 months | Change in dynamic balance assessed using step recovery method |
| Change in static balance | Baseline, 1 month, 6 months, 7 months, and 12 months | Change in static balance assessed using force plates |
Countries
United States
Outcome results
None listed