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Completed

NCT Number: NCT05636241

Whole Body Vibration in Children With Cerebral Palsy

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.

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Key information

Conditions

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

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KMSU

Kütahya, 43100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.

    Time frame: 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.

  2. Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.

    Time frame: Change from baseline stride 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 stride length will be collected as centimeters from the entire 1-minute walk will use for analysis.

  3. Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.

    Time frame: Change from baseline step width 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 width will be collected as centimeters from the entire 1-minute walk will use for analysis.

  4. Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.

    Time frame: Change from baseline step time 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 dataabout step time will be collected as seconds from the entire 1-minute walk will use for analysis.

  5. Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.

    Time frame: Change from baseline cadance 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 cadence will be collected as counts of steps from the entire 1-minute walk will use for analysis.

  6. Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.

    Time frame: Change from baseline velocity 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 velocity will be collected as meters/seconds from the entire 1-minute walk will use for analysis.

Secondary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

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

Acronym: CP

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 5, 2022
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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