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Cerebral Palsy, SpasticNCT03484078

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

A study testing Vibration Platform in people with Cerebral Palsy, Spastic, run by University of Georgia at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 11 years
Conditions the study is for
Cerebral Palsy, Spastic
What is being tested?
Vibration Platform
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteUnited States
Study dates
23 Jan 2019to 30 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Georgia

    Athens, Georgia, 30602

Other trials in United States

About this study

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.

Read the 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.

Being tested
Vibration Platform, Placebo Platform
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vibration PlatformDevice

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

  • Placebo PlatformDevice

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

Study groups in NCT03484078
Study groupRoleWhat they receive
Vibration PlatformExperimentalThe 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.
Receives: Device: Vibration Platform
Placebo PlatformPlacebo comparatorThe 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.
Receives: Device: Placebo Platform

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in fat concentration

    Change in fat concentration assessed using imaging techniques

    Measured: Baseline, 6 months and 12 months

Secondary outcomes (4)

  1. Change in muscle size

    Change in muscle size assessed using imaging techniques

    Measured: Baseline, 6 months and 12 months

  2. Change in physical activity

    Change in physical activity assessed using activity monitors

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

  3. Change in dynamic balance

    Change in dynamic balance assessed using step recovery method

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

  4. Change in static balance

    Change in static balance assessed using force plates

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2018
  2. Study start23 Jan 2019
  3. Primary completion1 Mar 2024
  4. Study completion30 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Children with CP will be randomly assigned to a vibration or a placebo group.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03484078
Sponsor's protocol ID
STUDY00004873
Status last verified
Jan 2025
First submitted
13 Mar 2018
Last updated
8 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Khan OA, Rai D, Crabtree B, Whitten SVW, Hines D, Colquitt G, Modlesky CM, Xu J. Three-dimensional assessment of finger individuation reveals finger- and joint-specific selective motor control deficits in children with cerebral palsy. J Neuroeng Rehabil. 2026 Feb 20;23(1):73. doi: 10.1186/s12984-025-01832-4.

    PubMed 41721406

  • 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.

    PubMed 39702205

Questions about this trial

What is this clinical trial studying?

A study testing Vibration Platform in people with Cerebral Palsy, Spastic, run by University of Georgia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fat concentration (time frame: Baseline, 6 months and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03484078, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.

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