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Whole Body Vibration in Children With Cerebral Palsy (CP)

Primary Purpose

Cerebral Palsy, Spastic

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
conventional physiotherapy program
whole body vibration training program
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cerebral Palsy focused on measuring cerebral palsy, whole body vibration, gait, balance

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • KMSU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

study group

Arm Description

The participants in the control group will be attended to conventional physiotherapy program.

The participants in the study group will be attended to whole body vibration training program.

Outcomes

Primary Outcome Measures

Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
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.
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
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.
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
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.
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
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.
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
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.
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
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.

Secondary Outcome Measures

The Pediatric Balance Scale will be used to measure functional balance of the participants.
Scale consist of 14-item. The highest score that can be obtained from the scale is 56. Highest scores shows better balance skills.

Full Information

First Posted
October 28, 2022
Last Updated
September 1, 2023
Sponsor
Kutahya Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT05636241
Brief Title
Whole Body Vibration in Children With Cerebral Palsy
Acronym
CP
Official Title
The Effect of Whole Body Vibration on Walking Parameters in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 20, 2023 (Actual)
Primary Completion Date
August 20, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic
Keywords
cerebral palsy, whole body vibration, gait, balance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
The participants in the control group will be attended to conventional physiotherapy program.
Arm Title
study group
Arm Type
Experimental
Arm Description
The participants in the study group will be attended to whole body vibration training program.
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
whole body vibration training program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
Description
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.
Time Frame
Change from baseline step length at 2 months.
Title
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
Description
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.
Time Frame
Change from baseline stride length at 2 months.
Title
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
Description
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.
Time Frame
Change from baseline step width at 2 months.
Title
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
Description
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.
Time Frame
Change from baseline step time at 2 months.
Title
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
Description
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.
Time Frame
Change from baseline cadance at 2 months.
Title
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
Description
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.
Time Frame
Change from baseline velocity at 2 months.
Secondary Outcome Measure Information:
Title
The Pediatric Balance Scale will be used to measure functional balance of the participants.
Description
Scale consist of 14-item. The highest score that can be obtained from the scale is 56. Highest scores shows better balance skills.
Time Frame
Change from baseline score at 2 months.
Other Pre-specified Outcome Measures:
Title
Spasticity level of the participants will be measure with Modified Ashworth Scale.
Description
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.
Time Frame
Change from baseline score at 2 months.
Title
Functional mobility of the participants will be measure with 1-min walk test.
Description
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.
Time Frame
Change from baseline distance at 2 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eda Ozge Okur
Organizational Affiliation
Kutahya Health Sciences University
Official's Role
Principal Investigator
Facility Information:
Facility Name
KMSU
City
Kutahya
ZIP/Postal Code
43100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31523683
Citation
Han YG, Lee SW, Yun CK. The immediate influence of various whole-body vibration frequency on balance and walking ability in children with cerebral palsy: a pilot study. J Exerc Rehabil. 2019 Aug 28;15(4):597-602. doi: 10.12965/jer.1938318.159. eCollection 2019 Aug.
Results Reference
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Whole Body Vibration in Children With Cerebral Palsy

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