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| Name | Class |
|---|---|
| Emory University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vibration Platform | Experimental | 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. |
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| Placebo Platform | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibration Platform | Device | The vibration platform will emit a mild vibration when the participant stands on it 10 minutes per day for 6 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in fat concentration | Change in fat concentration assessed using imaging techniques | Baseline, 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in muscle size | Change in muscle size assessed using imaging techniques | Baseline, 6 months and 12 months |
| Change in physical activity | Change in physical activity assessed using activity monitors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher M Modlesky, PhD | University of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Georgia | Athens | Georgia | 30602 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41721406 | Derived | Khan OA, Rai D, Crabtree B, Whitten SVW, Hines D, Colquitt G, Modlesky CM, Xu J. Three-dimensional assessment of finger individuation reveals finger- and joint-specific selective motor control deficits in children with cerebral palsy. J Neuroeng Rehabil. 2026 Feb 20;23(1):73. doi: 10.1186/s12984-025-01832-4. | |
| 39702205 | Derived |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Children with CP will be randomly assigned to a vibration or a placebo group.
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| Placebo Platform | Device | The placebo platform will not vibrate when the participant stands on it 10 minutes per day for 6 months. |
|
| Baseline, 1 month, 6 months, 7 months, and 12 months |
| Change in dynamic balance | Change in dynamic balance assessed using step recovery method | Baseline, 1 month, 6 months, 7 months, and 12 months |
| Change in static balance | Change in static balance assessed using force plates | Baseline, 1 month, 6 months, 7 months, and 12 months |
| Khan OA, Singh T, Barany DA, Modlesky CM. Accuracy deficits during robotic time-constrained reaching are related to altered prefrontal cortex activity in children with cerebral palsy. J Neuroeng Rehabil. 2024 Dec 19;21(1):216. doi: 10.1186/s12984-024-01502-x. |