Clinical trial NCT03484078: Effect of Vibration on Muscle Properties, Physical Activity and Balance in Children with Cerebral Palsy
Official title: Effect of Vibration on Muscle Properties, Physical Activity and Balance in Children with Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Palsy, Spastic
Lead sponsor: University of Georgia
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2018-03-30
Enrollment: 44
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children with CP will be randomly assigned to a vibration or a placebo group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in fat concentration
timeFrame: Baseline, 6 months and 12 months
Secondary outcomes:
measure: Change in muscle size
timeFrame: Baseline, 6 months and 12 months
measure: Change in physical activity
timeFrame: Baseline, 1 month, 6 months, 7 months, and 12 months
measure: Change in dynamic balance
timeFrame: Baseline, 1 month, 6 months, 7 months, and 12 months
measure: Change in static balance
timeFrame: Baseline, 1 month, 6 months, 7 months, and 12 months
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia
state: Georgia
Study officials:
affiliation: University of Georgia
name: Christopher M Modlesky, PhD
role: PRINCIPAL_INVESTIGATOR
References: