Whole Body Vibration in Children With Cerebral Palsy

Not Applicable

Completed

• Conditions: Spastic; Cerebral Palsy

• Registration Number: NCT05636241
• Lead Sponsor: Kutahya Health Sciences University

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.

Study Timeline

• Study First Submitted: 2022-10-28
• Study First Submitted QC: 2022-11-23
• Study First Posted: 2022-12-05
• Study Start: 2023-05-20
• Primary Completion: 2023-08-20
• Study Completion: 2023-08-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The Pediatric Balance Scale will be used to measure functional balance of the participants.	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.

Trial Locations

Locations (1)

KMSU; 🇹🇷 Kutahya, Turkey