Whole Body Vibration in Children With Cerebral Palsy (CP)

September 1, 2023 updated by: Eda Ozge OKUR, Kutahya Health Sciences University

The Effect of Whole Body Vibration on Walking Parameters in Children With Cerebral Palsy

Some positive effects of whole body vibration applications in reducing spasticity, improving walking ability, and increasing walking speed have been reported in children with CP, but the evidence is not strong enough. Therefore, this study was planned to evaluate the effect of whole body vibration treatment on spasticity, gait, balance, and motor performance in children with spastic CP. This study hypothesis that whole body vibration provides an additive improvement on spasticity, balance, gait and motor performance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be evaluate at baseline, after the conventional physiotherapy program, and after whole body vibration training program. During this period, the participants who were recruited whole body vibration training program, whole body vibration will be applied in addition to conventional physiotherapy sessions comprised 45 min, 2 days a week, during 8 week.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kutahya, Turkey, 43100
        • KMSU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children diagnosed with spastic diplegic CP in GMFCS levels I and II, CFCS level I and MACS levels I and II
  • Aged 6-17 years
  • Ability to cooperate with the evaluations
  • Walking independently with or without an orthosis (without any support)

Exclusion Criteria:

  • Having a recent injury affecting the lower extremities
  • Having undergone any surgery or Botulinuim Toxin application within the last six months
  • Having severe cardiopulmonary or systemic problems
  • Having uncontrolled seizures, visual or hearing problems preventing the evaluations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
The participants in the control group will be attended to conventional physiotherapy program.
Other: conventional physiotherapy program
The conventional physiotherapy program consists of stretching exercises for lower extremities, strength exercises for core, upper, and lower extremity muscles, sit to stand exercises, and balance exercises.
Experimental: study group
The participants in the study group will be attended to whole body vibration training program.
Other: whole body vibration training program
The whole body vibration training program sessions consisted of three 3-min bouts of vibration of 20 Hz and a peak-to-peak amplitude of 2mm with a 3-min rest in between, in addition to conventional physiotherapy exercises for children with cerebral palsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
Time Frame: Change from baseline step length at 2 months.
Gait analysis will be performed without any shoes and assistive devices. Walking evaluation on the gait platform will be limited to 1 minute. Obtained data about step length will be collected as centimeters from the entire 1-minute walk will use for analysis.
Change from baseline step length at 2 months.
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
Time Frame: Change from baseline stride length at 2 months.
Gait analysis will be performed without any shoes and assistive devices. Walking evaluation on the gait platform will be limited to 1 minute. Obtained data about stride length will be collected as centimeters from the entire 1-minute walk will use for analysis.
Change from baseline stride length at 2 months.
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
Time Frame: Change from baseline step width at 2 months.
Gait analysis will be performed without any shoes and assistive devices. Walking evaluation on the gait platform will be limited to 1 minute. Obtained data about step width will be collected as centimeters from the entire 1-minute walk will use for analysis.
Change from baseline step width at 2 months.
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
Time Frame: Change from baseline step time at 2 months.
Gait analysis will be performed without any shoes and assistive devices. Walking evaluation on the gait platform will be limited to 1 minute. Obtained dataabout step time will be collected as seconds from the entire 1-minute walk will use for analysis.
Change from baseline step time at 2 months.
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
Time Frame: Change from baseline cadance at 2 months.
Gait analysis will be performed without any shoes and assistive devices. Walking evaluation on the gait platform will be limited to 1 minute. Obtained data about cadence will be collected as counts of steps from the entire 1-minute walk will use for analysis.
Change from baseline cadance at 2 months.
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
Time Frame: Change from baseline velocity at 2 months.
Gait analysis will be performed without any shoes and assistive devices. Walking evaluation on the gait platform will be limited to 1 minute. Obtained data about velocity will be collected as meters/seconds from the entire 1-minute walk will use for analysis.
Change from baseline velocity at 2 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Pediatric Balance Scale will be used to measure functional balance of the participants.
Time Frame: Change from baseline score at 2 months.
Scale consist of 14-item. The highest score that can be obtained from the scale is 56. Highest scores shows better balance skills.
Change from baseline score at 2 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spasticity level of the participants will be measure with Modified Ashworth Scale.
Time Frame: Change from baseline score at 2 months.
Muscle tone will be evaluated using the Modified Ashworth Scale from the right and left elbow flexors, forearm pronators, knee flexors, ankle plantar flexors, and hip adductors. The possible scores ranged from 0-4 for each movement, and lower scores indicate better outcome and higher scores indicate worse outcome.
Change from baseline score at 2 months.
Functional mobility of the participants will be measure with 1-min walk test.
Time Frame: Change from baseline distance at 2 months.
Participants will be tested with their usual walking aids, orthoses and shoes. Before the test, a trial test will be performed. After 5 minutes resting period, the participant will be asked to walk as fast as possible without running on the 20 meter oval track during 1 minute. When the time is over, the distance the participant has walked will be measured in meters and recorded.
Change from baseline distance at 2 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kutahya Health Sciences University

Investigators

  • Principal Investigator: Eda Ozge Okur, Kutahya Health Sciences University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2023

Primary Completion (Actual)

August 20, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

October 28, 2022

First Submitted That Met QC Criteria

November 23, 2022

First Posted (Actual)

December 5, 2022

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WBWinCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Palsy

Clinical Trials on conventional physiotherapy program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe