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

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ClinicalTrials.gov Identifier: NCT03484078
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Christopher Modlesky, University of Georgia

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy, Spastic Device: Vibration Platform Device: Placebo Platform Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Children with CP will be randomly assigned to a vibration or a placebo group.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vibration on Muscle Properties, Physical Activity and Balance in Children With Cerebral Palsy
Estimated Study Start Date : November 2, 2018
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in fat concentration [ Time Frame: Baseline, 6 months and 12 months ]
    Change in fat concentration assessed using imaging techniques


Secondary Outcome Measures :
  1. Change in muscle size [ Time Frame: Baseline, 6 months and 12 months ]
    Change in muscle size assessed using imaging techniques

  2. Change in physical activity [ Time Frame: Baseline, 1 month, 6 months, 7 months, and 12 months ]
    Change in physical activity assessed using activity monitors

  3. Change in dynamic balance [ Time Frame: Baseline, 1 month, 6 months, 7 months, and 12 months ]
    Change in dynamic balance assessed using step recovery method

  4. Change in static balance [ Time Frame: Baseline, 1 month, 6 months, 7 months, and 12 months ]
    Change in static balance assessed using force plates



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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484078


Contacts
Contact: Katherine A Collins, MS 706-395-5085 uga.cp.research@gmail.com

Locations
United States, Georgia
University of Georgia Recruiting
Athens, Georgia, United States, 30602
Contact: Katherine A Collins, MS    706-395-5085    uga.cp.research@gmail.com   
Sponsors and Collaborators
University of Georgia
Emory University
Investigators
Principal Investigator: Christopher M Modlesky, PhD University of Georgia

Responsible Party: Christopher Modlesky, Professor, University of Georgia
ClinicalTrials.gov Identifier: NCT03484078     History of Changes
Other Study ID Numbers: STUDY00004873
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases