Clinical trial NCT05636241: Whole Body Vibration in Children With Cerebral Palsy
Official title: The Effect of Whole Body Vibration on Walking Parameters in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Spastic
Keywords: cerebral palsy
whole body vibration
gait
balance
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 13
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
timeFrame: Change from baseline step length at 2 months.
measure: Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
timeFrame: Change from baseline stride length at 2 months.
measure: Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
timeFrame: Change from baseline step width at 2 months.
measure: Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
timeFrame: Change from baseline step time at 2 months.
measure: Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
timeFrame: Change from baseline cadance at 2 months.
measure: Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
timeFrame: Change from baseline velocity at 2 months.
Secondary outcomes:
measure: The Pediatric Balance Scale will be used to measure functional balance of the participants.
timeFrame: Change from baseline score at 2 months.
Other outcomes:
measure: Spasticity level of the participants will be measure with Modified Ashworth Scale.
timeFrame: Change from baseline score at 2 months.
measure: Functional mobility of the participants will be measure with 1-min walk test.
timeFrame: Change from baseline distance at 2 months.
Locations:
city: Kutahya
country: Turkey
facility: KMSU
Study officials:
affiliation: Kutahya Health Sciences University
name: Eda Ozge Okur
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.