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

NCT03484078 | Active Not Recruiting FDA Device

• 1 other identifier: STUDY00004873
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Spastic

Outcome Measures

Primary Outcomes (1)

• Change in fat concentration

  Change in fat concentration assessed using imaging techniques

  Baseline, 6 months and 12 months

Secondary Outcomes (4)

• Change in muscle size

  Baseline, 6 months and 12 months

• Change in physical activity

  Baseline, 1 month, 6 months, 7 months, and 12 months

• Change in dynamic balance

  Baseline, 1 month, 6 months, 7 months, and 12 months

• Change in static balance

  Baseline, 1 month, 6 months, 7 months, and 12 months

Study Arms (2)

Vibration Platform

EXPERIMENTAL

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

Placebo Platform

PLACEBO COMPARATOR

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

Interventions

Vibration Platform DEVICE

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

Vibration Platform

Placebo Platform DEVICE

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

Placebo Platform

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Spastic cerebral palsy
• Independent ambulator without an assistive device (Gross Motor Function Classification System level I or II)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Georgia: lead
• Emory University: collaborator

Study Sites (1)

University of Georgia

Athens, Georgia, 30602, United States

Location

Related Publications (1)

• Khan OA, Singh T, Barany DA, Modlesky CM. Accuracy deficits during robotic time-constrained reaching are related to altered prefrontal cortex activity in children with cerebral palsy. J Neuroeng Rehabil. 2024 Dec 19;21(1):216. doi: 10.1186/s12984-024-01502-x.

  PMID: 39702205 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Christopher M Modlesky, PhD

  University of Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Children with CP will be randomly assigned to a vibration or a placebo group.

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 30, 2018
• Study Start: January 23, 2019
• Primary Completion: March 1, 2024
• Study Completion: January 30, 2026
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)