AtaxiaNCT04183647
Investigation of Acute Effects of Local Vibration and Whole-Body Vibration Applications
A study testing whole body vibration / local vibration in people with Ataxia, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study was designed as a single-blind, randomized and cross-over study to investigate and compare the acute effects of local vibration (LV) and whole-body vibration (WBV) applications on postural control in adult patients with ataxia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ataxia
- What is being tested?
- whole body vibration / local vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2018to 1 Jul 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Located in the 18-50 age range, diagnosed with ataxia by the neurologist, patients who can walk independently
Who cannot join
- Patients with pregnancy status, epilepsy, spasticity, implant / endoprosthesis / pacemaker, benign paroxysmal positional vertigo, history of fracture in the last 6 months, and other neurological disorders other than ataxia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
Ankara, 06100
About this study
Official title: Investigation of Acute Effects of Local Vibration and Whole-Body Vibration Applications on Postural Control in Adult Patients With Ataxia
This study was designed as a single-blind, randomized and cross-over study to investigate and compare the acute effects of local vibration (LV) and whole-body vibration (WBV) applications on postural control in adult patients with ataxia.
The study will be included in patients aged 18-50 years, including ataxia diagnosed by the neurologist and able to walk independently. Patients with pregnancy status, epilepsy, spasticity, implant / endoprosthesis / pacemaker, benign paroxysmal positional vertigo, history of fracture in the last 6 months and other neurological diseases other than ataxia will not be included in the study. Between the applications, a washout period of one week will be given to each patient to apply both local and whole body vibrations. The order of application will be decided by the coin toss randomization method. Descriptive evaluations of the patients will be done with Mini-BESTest and Trunk Impairment Scale. Stability limits and postural sways (Bertec Balance Check ScreenerTM), gait time - distance characteristics (GAITRite), functional mobility skills (Timed Up and Go Test), and static balances (One Leg Stance Test) before, 1 minute after the application and 60 minutes after the application.
- Conditions
- Ataxia
- Being tested
- whole body vibration / local vibration
- Keywords
- local vibration, whole body vibration, postural control
- Medical subject headings
- Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibration / local vibrationDevice
Both the whole-body vibration application and the local vibration application will be applied to the patients in our cross-over study. Between the two applications will be given a washout period of one week. Patients will be evaluated both local and whole body vibration applications, 1 minute and 60 minutes after the end of the applications. After the evaluation, the patient will be rested in the sitting position until the evaluation at the 60th minute.
| Study group | Role | What they receive |
|---|---|---|
| Local Vibration / Whole body vibration | Active comparator | Local vibration will be sequentially applied to the bilateral gastrosoleus complex with the Vibrasens © device. Application, the largest part of the muscle, each limb 5'er for a total of 10 minutes, static semi-squat position will be done.
The vibration frequency is 80 Hz and the amplitude is 1 mm. Receives: Device: whole body vibration / local vibration |
| Whole body vibration/local vibration | Active comparator | Whole body vibration application will be done with Compex® Winplate device. During this application, patients will be asked to continue static semi-squat position with 5 minutes of vibration and then 5 minutes of vibration.Vibration frequency, 30 Hz amplitude will be selected 2 mm. Receives: Device: whole body vibration / local vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-BESTest
It will be used for performance-oriented balance assessment. The test consists of 14 items and is evaluated on a score of 0-2. In the test, "0" indicates the lowest function level and "2 en indicates the highest function level.
Measured: The application will be made immediately after the evaluations are completed within the same day (on average 45 min before application).
Trunk Impairment Scale
It will be used to evaluate trunk control. The scale has 17 items, 3 of which are static balance 10 are dynamic balance, 4 are stabilizer muscles. The total score that can be obtained is minimum "0 minimum and maximum" 23..
Measured: The application will be made immediately after the evaluations are completed within the same day (on average 30 min before application).
Limits of Stability and Postural Sways
Bertec Balance Check Screener (Model BP5050) force platform system will be used. This force platform will measure stability limits in 4 directions (anterior, posterior, right, left) and postural sways in 4 different conditions (firm surface -eyes open, firm surface-eyes closed, foam surface-eyes open, foam surface-eyes closed).
Measured: change from baseline at 1 min and 60 min after applications.
Time-Distance Characteristics of the Gait
GAITRite (CIR System INC. Clifton, NJ 07012) walkway system will be used. GAITRite; It is an electronic walkway which consists of portable carpet and sensors embedded on the carpet and transfers every foot contact to the computer when individuals walk on the carpet. With GAITRite, base of support (cm), velocity (cm / s) and cadence (steps / min) parameters will be evaluated.
Measured: change from baseline at 1 min and 60 min after applications.
Timed Up and Go Test
It will be used to evaluate functional mobility.
Measured: change from baseline at 1 min and 60 min after applications.
One Leg Stance Test
It will be used to evaluate static balance. For the right and left lower extremities, eyes will be opened and closed in two ways.
Measured: change from baseline at 1 min and 60 min after applications.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start15 Nov 2018
- Primary completion1 May 2019
- Study completion1 Jul 2019
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 AtaxiaStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Crossover
- Model description
- Between the applications, a washout period of one week will be given to each patient to apply both local and whole body vibrations.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güngör Beyza ÖZVAR, Hacettepe University
- Investigators
- Muhammed KILINÇ, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183647
- Sponsor's protocol ID
- Vibration Applications
- Status last verified
- Jan 2020
- First submitted
- 24 Nov 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozvar GB, Ayvat E, Kilinc M. Immediate Effects of Local Vibration and Whole-body Vibration on Postural Control in Patients with Ataxia: an Assessor-Blind, Cross-over randomized trial. Cerebellum. 2021 Feb;20(1):83-91. doi: 10.1007/s12311-020-01187-7. Epub 2020 Sep 3.
PubMed 32880847
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Acute Effects of Local Vibration and Whole-Body Vibration Applications on Postural Control in Adult Patients With Ataxia
- ClinicalTrials.gov ID
- NCT04183647
- Acronym / sponsor ID
- Vibration Applications
- Conditions
- Ataxia
- Keywords
- local vibration, whole body vibration, postural control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 3 Dec 2019 (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.
This study was designed as a single-blind, randomized and cross-over study to investigate and compare the acute effects of local vibration (LV) and whole-body vibration (WBV) applications on postural control in adult patients with ataxia.
The study will be included in patients aged 18-50 years, including ataxia diagnosed by the neurologist and able to walk independently. Patients with pregnancy status, epilepsy, spasticity, implant / endoprosthesis / pacemaker, benign paroxysmal positional vertigo, history of fracture in the last 6 months and other neurological diseases other than ataxia will not be included in the study. Between the applications, a washout period of one week will be given to each patient to apply both local and whole body vibrations. The order of application will be decided by the coin toss randomization method. Descriptive evaluations of the patients will be done with Mini-BESTest and Trunk Impairment Scale. Stability limits and postural sways (Bertec Balance Check ScreenerTM), gait time - distance characteristics (GAITRite), functional mobility skills (Timed Up and Go Test), and static balances (One Leg Stance Test) before, 1 minute after the application and 60 minutes after the application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Between the applications, a washout period of one week will be given to each patient to apply both local and whole body vibrations.
| Arm | Type | Receives |
|---|---|---|
| Local Vibration / Whole body vibration | Active comparator | Device: whole body vibration / local vibrationLocal vibration will be sequentially applied to the bilateral gastrosoleus complex with the Vibrasens © device. Application, the largest part of the muscle, each limb 5'er for a total of 10 minutes, static semi-squat position will be done. The vibration frequency is 80 Hz and the amplitude is 1 mm. |
| Whole body vibration/local vibration | Active comparator | Device: whole body vibration / local vibrationWhole body vibration application will be done with Compex® Winplate device. During this application, patients will be asked to continue static semi-squat position with 5 minutes of vibration and then 5 minutes of vibration.Vibration frequency, 30 Hz amplitude will be selected 2 mm. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Located in the 18-50 age range, diagnosed with ataxia by the neurologist, patients who can walk independently
Key exclusion criteria (1 listed)
- Patients with pregnancy status, epilepsy, spasticity, implant / endoprosthesis / pacemaker, benign paroxysmal positional vertigo, history of fracture in the last 6 months, and other neurological disorders other than ataxia
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 vibration / local vibrationBoth the whole-body vibration application and the local vibration application will be applied to the patients in our cross-over study. Between the two applications will be given a washout period of one week. Patients will be evaluated both local and whole body vibration applications, 1 minute and 60 minutes after the end of the applications. After the evaluation, the patient will be rested in the sitting position until the evaluation at the 60th minute. | Device | Local Vibration / Whole body vibration, Whole body vibration/local vibration |
Primary outcome
Mini-BESTest
Time frame: The application will be made immediately after the evaluations are completed within the same day (on average 45 min before application).
It will be used for performance-oriented balance assessment. The test consists of 14 items and is evaluated on a score of 0-2. In the test, "0" indicates the lowest function level and "2 en indicates the highest function level.
Trunk Impairment Scale
Time frame: The application will be made immediately after the evaluations are completed within the same day (on average 30 min before application).
It will be used to evaluate trunk control. The scale has 17 items, 3 of which are static balance 10 are dynamic balance, 4 are stabilizer muscles. The total score that can be obtained is minimum "0 minimum and maximum" 23..
Limits of Stability and Postural Sways
Time frame: change from baseline at 1 min and 60 min after applications.
Bertec Balance Check Screener (Model BP5050) force platform system will be used. This force platform will measure stability limits in 4 directions (anterior, posterior, right, left) and postural sways in 4 different conditions (firm surface -eyes open, firm surface-eyes closed, foam surface-eyes open, foam surface-eyes closed).
Time-Distance Characteristics of the Gait
Time frame: change from baseline at 1 min and 60 min after applications.
GAITRite (CIR System INC. Clifton, NJ 07012) walkway system will be used. GAITRite; It is an electronic walkway which consists of portable carpet and sensors embedded on the carpet and transfers every foot contact to the computer when individuals walk on the carpet. With GAITRite, base of support (cm), velocity (cm / s) and cadence (steps / min) parameters will be evaluated.
Timed Up and Go Test
Time frame: change from baseline at 1 min and 60 min after applications.
It will be used to evaluate functional mobility.
One Leg Stance Test
Time frame: change from baseline at 1 min and 60 min after applications.
It will be used to evaluate static balance. For the right and left lower extremities, eyes will be opened and closed in two ways.
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 6 Jan 2020.
- Derived from this study: PubMed 32880847Ozvar GB, Ayvat E, Kilinc M. Immediate Effects of Local Vibration and Whole-body Vibration on Postural Control in Patients with Ataxia: an Assessor-Blind, Cross-over randomized trial. Cerebellum. 2021 Feb;20(1):83-91. doi: 10.1007/s12311-020-01187-7. Epub 2020 Sep 3.
- 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.
Muhammed KILINÇ study director
Hacettepe 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 whole body vibration / local vibration in people with Ataxia, run by Hacettepe 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 1 inclusion and 1 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 6 Jan 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?
Mini-BESTest (time frame: The application will be made immediately after the evaluations are completed within the same day (on average 45 min before application).). 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 NCT04183647, 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 6 Jan 2020.