Cerebral PalsyNCT04528966
Effects of WBV in Children With Hemiparetic CP
A study testing Whole-Body Vibration and Conventional Physiotherapy in people with Cerebral Palsy and Whole Body Vibration, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy, Whole Body Vibration, Spastic Hemiplegia
- What is being tested?
- Whole-Body Vibration and Conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- any other neurological diseases
- cooperation problems
- visual or auditory disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Whole-Body Vibration, Conventional Physiotherapy
- Keywords
- Cerebral Palsy, Spasticity, Motor Performance, Whole-Body Vibration, Conventional Physical Therapy
- Medical subject headings
- Cerebral Palsy, Hemiplegia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Body VibrationOther
Whole-Body Vibration Treatment for 3 sessions in a week for 8 weeks. Each sessions takes 15 minutes.
Conventional PhysiotherapyOther
conventional physiotherapy for 2 sessions in a week for 8 weeks. Each sessions takes 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Group that have received whole-body vibration treatment in addition to conventional physiotherapy Receives: Other: Whole-Body Vibration; Other: Conventional Physiotherapy |
| Control group | Active comparator | Group that have received conventional physiotherapy only Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Mar 2018
- Primary completion1 Aug 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Tekin, Pamukkale University
- Investigators
- Fatih Tekin, PT PhD, Principal investigator, Research Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528966
- Sponsor's protocol ID
- PamukkaleUni
- Status last verified
- Aug 2020
- First submitted
- 15 Feb 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long-Term Effects of Whole Body Vibration on Spasticity and Motor Performance in Children With Hemiparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04528966
- Acronym / sponsor ID
- PamukkaleUni
- Keywords
- Cerebral Palsy, Spasticity, Motor Performance, Whole-Body Vibration, Conventional Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Whole-Body Vibration, Other: Conventional PhysiotherapyGroup that have received whole-body vibration treatment in addition to conventional physiotherapy |
| Control group | Active comparator | Other: Conventional PhysiotherapyGroup that have received conventional physiotherapy only |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- any other neurological diseases
- cooperation problems
- visual or auditory disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-Body VibrationWhole-Body Vibration Treatment for 3 sessions in a week for 8 weeks. Each sessions takes 15 minutes. | Other | Treatment Group |
| Conventional Physiotherapyconventional physiotherapy for 2 sessions in a week for 8 weeks. Each sessions takes 45 minutes. | Other | Control group, Treatment Group |
Primary outcome
Gross Motor Functions assessed by Gross Motor Function Measure-88
Time frame: 1 year
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
Time frame: 1 year
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
Time frame: 1 year
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
Time frame: 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatih Tekin, PT PhD principal investigator
Research Assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-Body Vibration and Conventional Physiotherapy in people with Cerebral Palsy and Whole Body Vibration, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Functions assessed by Gross Motor Function Measure-88 (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.