Whole Body Vibration in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

— CP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05636241
• Other study ID #: WBWinCP
• Status: Completed
• Phase: N/A
• Start date: May 20, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2023
• Source: Kutahya Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 31, 2023
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis
• Spastic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	KMSU	Kutahya

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spasticity level of the participants will be measure with Modified Ashworth Scale.	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.
Other	Functional mobility of the participants will be measure with 1-min walk test.	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.	Change from baseline score at 2 months.