University of Georgia
Athens, Georgia, 30602, United States
NCT Number: NCT03484078
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.
This study is active but is not currently recruiting participants.
5 year–11 year
All sexes
Interventional
Not applicable
Athens, Georgia, 30602, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The vibration platform will emit a mild vibration when the participant stands on it 10 minutes per day for 6 months.
The placebo platform will not vibrate when the participant stands on it 10 minutes per day for 6 months.
Time frame: Baseline, 6 months and 12 months
Change in fat concentration assessed using imaging techniques
Time frame: Baseline, 6 months and 12 months
Change in muscle size assessed using imaging techniques
Time frame: Baseline, 1 month, 6 months, 7 months, and 12 months
Change in physical activity assessed using activity monitors
Time frame: Baseline, 1 month, 6 months, 7 months, and 12 months
Change in dynamic balance assessed using step recovery method
Time frame: Baseline, 1 month, 6 months, 7 months, and 12 months
Change in static balance assessed using force plates
University of Georgia
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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