Stroke PatientsNCT04034602
Immediate Effect of Plantar Vibration on Fall Risk and Postural Stability
A study testing vibration group in people with Stroke Patients, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study; To determine the immediate effect on fall risk and postural stability of vibration applied to the plantar region in stroke patients. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Stroke Patients
- What is being tested?
- vibration group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2018to 15 Aug 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cognitive and non-communication problems
- Volunteer to join the work
- Those with less than 150 kilos
- Spasticity according to a Modified Scale Ashworth 2 and 3 patients treated with Botox
- Patients at least 8 weeks after stroke diagnosis
Who cannot join
- People who are not stable due to vital signs
- Open wounds under the soles of the feet
- Being spastic at the level that will block the base touch
- Pathological conditions affecting lower limb sense (diabetic peripheral neuropathy, post- fracture surgery)
- 20 seconds independent standing
- Mini Mental Test score below 24
Show all 10Show fewer
- Multiple sclerosis, Parkinson's disease, etc.
- Those with vision problems
- Patients with thoracolumbar surgery
- Patients with spinal canal stenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effect of Plantar Vibration on Fall Risk and Postural Stability in Stroke Patients
The aim of this study; To determine the immediate effect on fall risk and postural stability of vibration applied to the plantar region in stroke patients.
Read the detailed description
Kırıkkale University Faculty of Medicine Physical Therapy will be hospitalized in the USA clinic and volunteers will be involved in stroke rehabilitation. The patients who meet the inclusion criteria and who are excluded from the exclusion criteria will be randomized according to the order of arrival and will be divided into two groups as the vibration group and the placebo group.Patients will be taken to the placebo and vibration group respectively in order of arrival. If the next patient falls outside the inclusion criteria of the study, randomization will be applied to the next patient. The vibration group, one session in supine position will be applied to both sides of the soles of the feet under the soles of the feet for 5 minutes with a 15-100 Hz frequency CE certified vibration device. In the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration.
- Conditions
- Stroke Patients
- Being tested
- vibration group, placebo group
- Keywords
- stroke vibration fall risk postural stability, immediate effect, fall risk, postural stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibration groupOther
plantar vibration group is supine position, plantar vibration will be applied to both foot of each patient with a vibration device with a frequency of 15-100 Hz over 5 minutes.
placebo groupOther
the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration.
| Study group | Role | What they receive |
|---|---|---|
| vibration group | Experimental | plantar vibration group is supine position, plantar vibration will be applied to both foot of each patient with a vibration device with a frequency of 15-100 Hz over 5 minutes. Receives: Other: vibration group |
| placebo group | Active comparator | the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration. Receives: Other: placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
biodex balance system fall risk test
Fall Risk Test is a test used to determine the risk of falling. The higher the score, the higher the risk of falling. The device compares the test results with normal age-related data to calculate the risk of falling, the platform was set to move from 12 to 8, with the platform moving. The test is carry out with 3 repetitions, each with a resting time of 10 seconds each, lasting 20 's each while the platform is static. On the support surface formed by placing the two legs in a comfortable position on the platform, it is requested to keep the black dot on the screen of the device in the middle of the visual on the screen for 20 seconds. The average of these 3 repetitions is automatically calculated by the device for the risk of falling.
Measured: 5 minutes
biodex balance system postural stability test
The Postural Stability Test assessment the participant's ability to control the center of gravity. The extent to which the participant's position deviates from the center is measured and reports the mean deviation as the stability index. A low score indicates that the amount of deviation is small and postural stability is good. If the standard deviation is high, the participant's postural oscillation is also high when the test platform is in a static state, each is 20 seconds lasting, between 10 seconds rest period was done as 3 repetitions. On the support surface formed by placing the two legs in a comfortable position on the platform, it was requested to keep the black dot on the screen of the device in the middle of the visual on the screen for 20 seconds. For the Mediolateral Stability Index, Anterioposterior Stability Index and General Stability Index showing the postural stability, the mean of 3 replicates of this test was automatically calculated by the device.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start5 Dec 2018
- Primary completion30 Jul 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke PatientsStudies of the same condition, open and under way.
- 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
- Model description
- 30 stroke patients will be included in this study. The patients who meet the inclusion criteria will be divided randomly into 2 groups as vibration (n=15) and placebo (n=15).The vibration group, one session in supine position will be applied to both sides of the soles of the feet under the soles of the feet for 5 minutes with a 15-100 Hz frequency CE certified vibration device. In the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birol Önal, Kırıkkale University
- Investigators
- Birol Önal, Principal investigator, Kirikkale Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034602
- Sponsor's protocol ID
- vibrationimmediateeffect
- Status last verified
- Oct 2019
- First submitted
- 24 Jul 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- 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 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Plantar Vibration on Fall Risk and Postural Stability in Stroke Patients
- ClinicalTrials.gov ID
- NCT04034602
- Acronym / sponsor ID
- vibrationimmediateeffect
- Conditions
- Stroke Patients
- Keywords
- stroke vibration fall risk postural stability, immediate effect, fall risk, postural stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 26 Jul 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.
The aim of this study; To determine the immediate effect on fall risk and postural stability of vibration applied to the plantar region in stroke patients.
Detailed description
Kırıkkale University Faculty of Medicine Physical Therapy will be hospitalized in the USA clinic and volunteers will be involved in stroke rehabilitation. The patients who meet the inclusion criteria and who are excluded from the exclusion criteria will be randomized according to the order of arrival and will be divided into two groups as the vibration group and the placebo group.Patients will be taken to the placebo and vibration group respectively in order of arrival. If the next patient falls outside the inclusion criteria of the study, randomization will be applied to the next patient. The vibration group, one session in supine position will be applied to both sides of the soles of the feet under the soles of the feet for 5 minutes with a 15-100 Hz frequency CE certified vibration device. In the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 30 stroke patients will be included in this study. The patients who meet the inclusion criteria will be divided randomly into 2 groups as vibration (n=15) and placebo (n=15).The vibration group, one session in supine position will be applied to both sides of the soles of the feet under the soles of the feet for 5 minutes with a 15-100 Hz frequency CE certified vibration device. In the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration.
| Arm | Type | Receives |
|---|---|---|
| vibration group | Experimental | Other: vibration groupplantar vibration group is supine position, plantar vibration will be applied to both foot of each patient with a vibration device with a frequency of 15-100 Hz over 5 minutes. |
| placebo group | Active comparator | Other: placebo groupthe placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cognitive and non-communication problems
- Volunteer to join the work
- Those with less than 150 kilos
- Spasticity according to a Modified Scale Ashworth 2 and 3 patients treated with Botox
- Patients at least 8 weeks after stroke diagnosis
Key exclusion criteria (10 listed)
- People who are not stable due to vital signs
- Open wounds under the soles of the feet
- Being spastic at the level that will block the base touch
- Pathological conditions affecting lower limb sense (diabetic peripheral neuropathy, post- fracture surgery)
- 20 seconds independent standing
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 |
|---|---|---|
| vibration groupplantar vibration group is supine position, plantar vibration will be applied to both foot of each patient with a vibration device with a frequency of 15-100 Hz over 5 minutes. | Other | vibration group |
| placebo groupthe placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration. | Other | placebo group |
Primary outcome
biodex balance system fall risk test
Time frame: 5 minutes
Fall Risk Test is a test used to determine the risk of falling. The higher the score, the higher the risk of falling. The device compares the test results with normal age-related data to calculate the risk of falling, the platform was set to move from 12 to 8, with the platform moving. The test is carry out with 3 repetitions, each with a resting time of 10 seconds each, lasting 20 's each while the platform is static. On the support surface formed by placing the two legs in a comfortable position on the platform, it is requested to keep the black dot on the screen of the device in the middle of the visual on the screen for 20 seconds. The average of these 3 repetitions is automatically calculated by the device for the risk of falling.
biodex balance system postural stability test
Time frame: 5 minutes
The Postural Stability Test assessment the participant's ability to control the center of gravity. The extent to which the participant's position deviates from the center is measured and reports the mean deviation as the stability index. A low score indicates that the amount of deviation is small and postural stability is good. If the standard deviation is high, the participant's postural oscillation is also high when the test platform is in a static state, each is 20 seconds lasting, between 10 seconds rest period was done as 3 repetitions. On the support surface formed by placing the two legs in a comfortable position on the platform, it was requested to keep the black dot on the screen of the device in the middle of the visual on the screen for 20 seconds. For the Mediolateral Stability Index, Anterioposterior Stability Index and General Stability Index showing the postural stability, the mean of 3 replicates of this test was automatically calculated by the device.
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 1 Nov 2019.
- 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.
Birol Önal principal investigator
Kirikkale Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vibration group in people with Stroke Patients, run by Kırıkkale 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 5 inclusion and 10 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 1 Nov 2019. 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?
biodex balance system fall risk test (time frame: 5 minutes). The study lists 2 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 1 Nov 2019.