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CompletedNCT04528966Updated Aug 27, 2020

Effects of WBV in Children With Hemiparetic CP

An interventional study of Whole-Body Vibration and Conventional Physiotherapy in Cerebral Palsy, Whole Body Vibration and Spastic Hemiplegia, sponsored by Pamukkale University. Completed at 1 site in Turkey. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-08-27.

Sponsored by Pamukkale University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Mar 2018, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study summary

The aim of this study was to investigate short and long-term effects of Whole Body Vibration therapy on spasticity and motor performance in children with hemiparetic cerebral palsy in addition to conventional physiotherapy.

Twenty-six patients undergoing conventional physiotherapy in a private rehabilitation center were included in the study. Patients were randomized to treatment and control groups. Study was completed with a total of 22 cases (11 for each group). At the beginning of the study, cases were evaluated with Gross Motor Function Measure-88, LEGSys Spatio-Temporal Gait Analyzer, SportKAT550tm Portable Computerized Kinesthetic Balance Device and Modified Ashworth Scale. Cases in the treatment group were treated with Compex-Winplate for 8 weeks, 3 times a week, 15 minutes a day in one session. All cases were reevaluated immediately after the treatment and 12 weeks after the treatment.

02

Conditions studied

  • Cerebral Palsy
  • Whole Body Vibration
  • Spastic Hemiplegia
  • Motor Performance

Keywords

  • Cerebral Palsy
  • Spasticity
  • Motor Performance
  • Whole-Body Vibration
  • Conventional Physical Therapy
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 437 are open to participants now.

This study's enrollment of 22 is below the median of 34 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Pamukkale University is the lead sponsor of 331 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with hemiparetic CP
  • patients were followed-up and treated by a special rehabilitation center
  • aged between 6-18 years
  • patients could walk independently without using assistive devices

Exclusion criteria

Exclusion Criteria:

  • any other neurological diseases
  • cooperation problems
  • visual or auditory disability
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Treatment Group

    Group that have received whole-body vibration treatment in addition to conventional physiotherapy

    Other: Whole-Body Vibration · Other: Conventional Physiotherapy

  • Active comparator
    Control group

    Group that have received conventional physiotherapy only

    Other: Conventional Physiotherapy

Interventions

  • OtherWhole-Body Vibration

    Whole-Body Vibration Treatment for 3 sessions in a week for 8 weeks. Each sessions takes 15 minutes.

  • OtherConventional Physiotherapy

    conventional physiotherapy for 2 sessions in a week for 8 weeks. Each sessions takes 45 minutes.

06

What researchers measure

Primary outcomes

  1. Gross Motor Functions assessed by Gross Motor Function Measure-88

    Gross Motor Function Measure-88 (GMFM-88) will be used to determine the functional skill level. GMFM-88 For a child with Cerebral Palsy (CP) with 5 sub-dimensions, lying, rolling (Dimension A), sitting (Dimension B), kneeling trunk control (Dimension C), standing (Dimension D) and walking activities (Dimension E) ) and measures the rate of realization of activities. Accordingly, the multiplication of the score obtained by the patient in each dimension by the division of the maximum score that can be obtained in that dimension by 100 indicates the percentage score obtained for that dimension. The total GMFM-88 score is obtained by dividing the sum of the scores obtained from the dimensions by 5 (Dimension A-E). As the score obtained increases, the level of performing gross motor skills of the patient with CP also increases.

    Time frame: 1 year

  2. Gait Parameters Assessed Using Modified Timed Up and Go Test by LegSys Spatio-Temporal Gait Analysis System

    The gait performance of the cases was evaluated with the spatio-temporal gait analyzer called LEGSys developed by BioSensics. The device consists of two sensors. The sensors are placed between the ankle joint and the knee joint of the patient to be tested, with the aid of velcro, closer to the ankle. The device is controlled from the computer with its own software and sends the raw data it collects to the computer instantly via Bluetooth. The software analyzes the raw data it receives from the device and converts it into results. For the evaluation, the Modified Timed Up and Go Test (MTUG), which was also supported by the device, was used. MTUG is a tool that assesses one's mobility and requires both static and dynamic balance. This test is a scale of the World Health Organization model of International Classification of Functioning Disability and Health. The test was repeated 2 times and the mean time was recorded.

    Time frame: 1 year

  3. Balance Skills Assessed by SportKAT 550

    The balance skills of the subjects were evaluated with SportKAT 550 portable computerized kinesthetic balance device, which was developed to evaluate the static and dynamic balance, which gives sensitive information about postural stability. The data obtained from the device are quantitative and objective. The Balancing Index measures a person's ability to hold the platform near the reference position. The scores ranges from 0 to 6000. Low score indicates good performance. For static tests, a PSI level of 5, a score of 250 or less, is excellent. A score of 500 is good. A score of over 750 indicates a defect in the equilibrium system and indicates a risk of falling. However, excellent, good or at-risk values vary from individual to individual.

    Time frame: 1 year

  4. Spasticity Assessed by Modified Ashworth Scale

    It is a widely used scale for the evaluation of spasticity. If the muscle to be tested is a flexor muscle, the joint is maximally extended in about one second while in the maximum flexion position. If the muscle to be tested is an extensor muscle, it is started when the joint is at maximum extension and maximized in one second. Scoring from 0 to 4 (0, 1, 1+, 2, 3, 4) is made according to resistance taken from muscle. It is also seen that various studies have scored "0,1,2,3,4,5" for MAS. The validity and reliability of this scoring method in hemiparetic individuals has been showed with different studies. 0 means no increase in muscle tone and 5 means that the limb is in a rigid position. In this study, knee extensors and ankle plantar flexors' spasticities were evaluated and total spasticity score was calculated by summing up one by one. Similarly, upper extremity total spasticity score was calculated by evaluating elbow flexors, forearm pronators and wrist flexors.

    Time frame: 1 year

07

Study locations

1 site
  • Pamukkale University
    Denizli, 20070, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04528966
Lead sponsor
Pamukkale University
Responsible party
Fatih Tekin (Principal Investigator, Pamukkale University) — Principal investigator
First posted
Aug 27, 2020
Start date
Mar 1, 2018
Primary completion
Aug 1, 2018
Completion
Mar 1, 2019
Last update
Aug 27, 2020

Study contacts

Fatih Tekin, PT PhD
principal investigator · Research Assistant

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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