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OpenTrials
Active, Not Recruiting

NCT Number: NCT03484078

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Georgia

Athens, Georgia, 30602, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibration Platform

Device

The vibration platform will emit a mild vibration when the participant stands on it 10 minutes per day for 6 months.

Placebo Platform

Device

The placebo platform will not vibrate when the participant stands on it 10 minutes per day for 6 months.

Primary outcomes

  1. Change in fat concentration

    Time frame: Baseline, 6 months and 12 months

    Change in fat concentration assessed using imaging techniques

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Collaborators

  • Emory University

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2026
First posted
Mar 30, 2018
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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