Whole Body Vibration in Children With Cerebral Palsy

NCT05636241 | Completed

• 1 other identifier: WBWinCP
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Spastic

Keywords

cerebral palsy; whole body vibration; gait; balance

Outcome Measures

Primary Outcomes (6)

• 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.

  Change from baseline step length at 2 months.

• 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.

  Change from baseline stride length at 2 months.

• 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.

  Change from baseline step width at 2 months.

• 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.

  Change from baseline step time at 2 months.

• 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.

  Change from baseline cadance at 2 months.

• 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.

  Change from baseline velocity at 2 months.

Secondary Outcomes (1)

• The Pediatric Balance Scale will be used to measure functional balance of the participants.

  Change from baseline score at 2 months.

Other Outcomes (2)

• Spasticity level of the participants will be measure with Modified Ashworth Scale.

  Change from baseline score at 2 months.

• Functional mobility of the participants will be measure with 1-min walk test.

  Change from baseline distance at 2 months.

Study Arms (2)

control group

ACTIVE COMPARATOR

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

Other: conventional physiotherapy program

study group

EXPERIMENTAL

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

Other: whole body vibration training program

Interventions

conventional physiotherapy program 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.

control group

whole body vibration training program 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.

study group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

KMSU

Kütahya, 43100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 31523683 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eda Ozge Okur

  Kutahya Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: December 5, 2022
• Study Start: May 20, 2023
• Primary Completion: August 20, 2023
• Study Completion: August 31, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)