Effects of WBV in Children With Hemiparetic CP
Primary Purpose
Cerebral Palsy, Whole Body Vibration, Spastic Hemiplegia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Whole-Body Vibration
Conventional Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Spasticity, Motor Performance, Whole-Body Vibration, Conventional Physical Therapy
Eligibility Criteria
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
Sites / Locations
- Pamukkale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment Group
Control group
Arm Description
Group that have received whole-body vibration treatment in addition to conventional physiotherapy
Group that have received conventional physiotherapy only
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04528966
First Posted
February 15, 2020
Last Updated
August 24, 2020
Sponsor
Pamukkale University
1. Study Identification
Unique Protocol Identification Number
NCT04528966
Brief Title
Effects of WBV in Children With Hemiparetic CP
Official Title
Short and Long-Term Effects of Whole Body Vibration on Spasticity and Motor Performance in Children With Hemiparetic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
March 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Whole Body Vibration, Spastic Hemiplegia, Motor Performance
Keywords
Cerebral Palsy, Spasticity, Motor Performance, Whole-Body Vibration, Conventional Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Group that have received whole-body vibration treatment in addition to conventional physiotherapy
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Group that have received conventional physiotherapy only
Intervention Type
Other
Intervention Name(s)
Whole-Body Vibration
Intervention Description
Whole-Body Vibration Treatment for 3 sessions in a week for 8 weeks. Each sessions takes 15 minutes.
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy
Intervention Description
conventional physiotherapy for 2 sessions in a week for 8 weeks. Each sessions takes 45 minutes.
Primary Outcome Measure Information:
Title
Gross Motor Functions assessed by Gross Motor Function Measure-88
Description
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
Title
Gait Parameters Assessed Using Modified Timed Up and Go Test by LegSys Spatio-Temporal Gait Analysis System
Description
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
Title
Balance Skills Assessed by SportKAT 550
Description
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
Title
Spasticity Assessed by Modified Ashworth Scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatih Tekin, PT PhD
Organizational Affiliation
Research Assistant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of WBV in Children With Hemiparetic CP
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