Whole Body Vibration in Children With Cerebral Palsy

NCT ID: NCT05636241

Last Updated: 2023-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-20

Study Completion Date

2023-08-31

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy Spastic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control group

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

Group Type ACTIVE_COMPARATOR

conventional physiotherapy program

Intervention Type OTHER

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.

study group

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

Group Type EXPERIMENTAL

whole body vibration training program

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kutahya Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Eda Ozge OKUR

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eda Ozge Okur

Role: PRINCIPAL_INVESTIGATOR

Kutahya Health Sciences University

Locations

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KMSU

Kütahya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 31523683 (View on PubMed)

Other Identifiers

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WBWinCP

Identifier Type: -

Identifier Source: org_study_id

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