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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cerebral Palsy, Spastic
• Intervention / Treatment: Device: Vibration Platform; Device: Placebo Platform

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.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30602
      • University of Georgia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vibration Platform; 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.	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 Comparator: Placebo Platform; 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.	Device: Placebo Platform; The placebo platform will not vibrate when the participant stands on it 10 minutes per day for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fat concentration	Change in fat concentration assessed using imaging techniques	Baseline, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Georgia
• Collaborators: Emory University
• Investigators: Principal Investigator: Christopher M Modlesky, PhD, University of Georgia

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 30, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: STUDY00004873

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes