Effects of WBV in Children With Hemiparetic CP

Short and Long-Term Effects of Whole Body Vibration on Spasticity and Motor Performance in Children With Hemiparetic Cerebral Palsy

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Motor Performance; Spastic Hemiplegia; Whole Body Vibration
• Intervention / Treatment: Other: Whole-Body Vibration; Other: Conventional Physiotherapy

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey, 20070
    • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Group that have received whole-body vibration treatment in addition to conventional physiotherapy	Other: Whole-Body Vibration; Whole-Body Vibration Treatment for 3 sessions in a week for 8 weeks. Each sessions takes 15 minutes.; Other: Conventional Physiotherapy; conventional physiotherapy for 2 sessions in a week for 8 weeks. Each sessions takes 45 minutes.
Active Comparator: Control group; Group that have received conventional physiotherapy only	Other: Conventional Physiotherapy; conventional physiotherapy for 2 sessions in a week for 8 weeks. Each sessions takes 45 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
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.	1 year
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.	1 year
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.	1 year

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Principal Investigator: Fatih Tekin, PT PhD, Research assistant

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: February 15, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Spasticity; Motor Performance; Whole-Body Vibration; Conventional Physical Therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Paralysis; Cerebral Palsy; Hemiplegia
• Other Study ID Numbers: PamukkaleUni

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No