search
Back to results

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

Primary Purpose

Cerebral Palsy, Spastic

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vibration Platform
Placebo Platform
Sponsored by
University of Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Georgia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vibration Platform

Placebo Platform

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in fat concentration
Change in fat concentration assessed using imaging techniques

Secondary Outcome Measures

Change in muscle size
Change in muscle size assessed using imaging techniques
Change in physical activity
Change in physical activity assessed using activity monitors
Change in dynamic balance
Change in dynamic balance assessed using step recovery method
Change in static balance
Change in static balance assessed using force plates

Full Information

First Posted
March 13, 2018
Last Updated
April 20, 2023
Sponsor
University of Georgia
Collaborators
Emory University
search

1. Study Identification

Unique Protocol Identification Number
NCT03484078
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia
Collaborators
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Children with CP will be randomly assigned to a vibration or a placebo group.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vibration Platform
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Platform
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vibration Platform
Intervention Description
The vibration platform will emit a mild vibration when the participant stands on it 10 minutes per day for 6 months.
Intervention Type
Device
Intervention Name(s)
Placebo Platform
Intervention Description
The placebo platform will not vibrate when the participant stands on it 10 minutes per day for 6 months.
Primary Outcome Measure Information:
Title
Change in fat concentration
Description
Change in fat concentration assessed using imaging techniques
Time Frame
Baseline, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Change in muscle size
Description
Change in muscle size assessed using imaging techniques
Time Frame
Baseline, 6 months and 12 months
Title
Change in physical activity
Description
Change in physical activity assessed using activity monitors
Time Frame
Baseline, 1 month, 6 months, 7 months, and 12 months
Title
Change in dynamic balance
Description
Change in dynamic balance assessed using step recovery method
Time Frame
Baseline, 1 month, 6 months, 7 months, and 12 months
Title
Change in static balance
Description
Change in static balance assessed using force plates
Time Frame
Baseline, 1 month, 6 months, 7 months, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher M Modlesky, PhD
Organizational Affiliation
University of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Georgia
City
Athens
State/Province
Georgia
ZIP/Postal Code
30602
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs