Cerebral PalsyCPNCT05636241
Whole Body Vibration in Children With Cerebral Palsy
A study testing conventional physiotherapy program and whole body vibration training program in people with Cerebral Palsy and Spastic, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- conventional physiotherapy program and whole body vibration training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2023to 31 Aug 2023
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Whole Body Vibration on Walking Parameters 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.
Read the detailed description
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.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- conventional physiotherapy program, whole body vibration training program
- Keywords
- cerebral palsy, whole body vibration, gait, balance
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physiotherapy programOther
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | The participants in the control group will be attended to conventional physiotherapy program. Receives: Other: conventional physiotherapy program |
| study group | Experimental | The participants in the study group will be attended to whole body vibration training program. Receives: Other: whole body vibration training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
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.
Measured: Change from baseline step length at 2 months.
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
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.
Measured: Change from baseline stride length at 2 months.
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
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.
Measured: Change from baseline step width at 2 months.
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
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.
Measured: Change from baseline step time at 2 months.
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
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.
Measured: Change from baseline cadance at 2 months.
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.
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.
Measured: Change from baseline velocity at 2 months.
Secondary outcomes (1)
The Pediatric Balance Scale will be used to measure functional balance of the participants.
Scale consist of 14-item. The highest score that can be obtained from the scale is 56. Highest scores shows better balance skills.
Measured: Change from baseline score at 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start20 May 2023
- Primary completion20 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Ozge OKUR, Kutahya Health Sciences University
- Investigators
- Eda Ozge Okur, Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636241
- Sponsor's protocol ID
- WBWinCP
- Acronym
- CP
- Status last verified
- Sep 2023
- First submitted
- 28 Oct 2022
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han YG, Lee SW, Yun CK. The immediate influence of various whole-body vibration frequency on balance and walking ability in children with cerebral palsy: a pilot study. J Exerc Rehabil. 2019 Aug 28;15(4):597-602. doi: 10.12965/jer.1938318.159. eCollection 2019 Aug.
PubMed 31523683
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whole Body Vibration on Walking Parameters in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05636241
- Acronym / sponsor ID
- CP / WBWinCP
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- cerebral palsy, whole body vibration, gait, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 5 Dec 2022 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: conventional physiotherapy programThe participants in the control group will be attended to conventional physiotherapy program. |
| study group | Experimental | Other: whole body vibration training programThe participants in the study group will be attended to whole body vibration training program. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| conventional physiotherapy programThe 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. | Other | control group |
| whole body vibration training programThe 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. | Other | study group |
Primary outcome
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.
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.
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.
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.
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.
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.
1 secondary outcome
The Pediatric Balance Scale will be used to measure functional balance of the participants.
Time frame: Change from baseline score at 2 months.
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 5 Sep 2023.
- Background: PubMed 31523683Han YG, Lee SW, Yun CK. The immediate influence of various whole-body vibration frequency on balance and walking ability in children with cerebral palsy: a pilot study. J Exerc Rehabil. 2019 Aug 28;15(4):597-602. doi: 10.12965/jer.1938318.159. eCollection 2019 Aug.
- 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.
Eda Ozge Okur principal investigator
Kutahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional physiotherapy program and whole body vibration training program in people with Cerebral Palsy and Spastic, run by Kutahya Health Sciences 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 4 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 5 Sep 2023. 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?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05636241, which also lists 1 linked publication.
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 5 Sep 2023.