An interventional study of conventional physiotherapy program and whole body vibration training program in Cerebral Palsy and Spastic, sponsored by Kutahya Health Sciences University. Completed at 1 site in Turkey. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-09-05.
Sponsored by Kutahya Health Sciences University · Not applicable, Interventional, and Supportive care
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.
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.
750 studies on the registry are indexed under Paralysis; 133 are open to participants now.
This study's enrollment of 13 is below the median of 30 across 537 interventional studies indexed under Paralysis.
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Exclusion Criteria:
The participants in the control group will be attended to conventional physiotherapy program.
Other: conventional physiotherapy program
The participants in the study group will be attended to whole body vibration training program.
Other: whole body vibration training 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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline velocity at 2 months.
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.
Time frame: Change from baseline score at 2 months.
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.
Time frame: Change from baseline score at 2 months.
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.
Time frame: Change from baseline distance at 2 months.
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Kutahya Health Sciences University