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Whole Body Vibration in Children With Cerebral Palsy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05636241
Acronym
CP
Enrollment
13
Registered
2022-12-05
Start date
2023-05-20
Completion date
2023-08-31
Last updated
2023-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Spastic

Keywords

cerebral palsy, whole body vibration, gait, balance

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.

Interventions

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.

OTHERwhole 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.

Sponsors

Kutahya Health Sciences University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.Change from baseline step length 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 step length will be collected as centimeters from the entire 1-minute walk will use for analysis.

Secondary

MeasureTime frameDescription
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.

Other

MeasureTime frameDescription
Spasticity level of the participants will be measure with Modified Ashworth Scale.Change from baseline score at 2 months.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.
Functional mobility of the participants will be measure with 1-min walk test.Change from baseline distance at 2 months.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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026