Acute Effect of Local Vibration Application in Stroke PatientsNCT06610994
Acute Effect of Local Vibration in Stroke Patients
A study testing local vibration apply in people with Acute Effect of Local Vibration Application in Stroke Patients, run by Kırıkkale University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of the research is to examine the acute effect of local vibration application on gait and balance in stroke patients. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Effect of Local Vibration Application in Stroke Patients
- What is being tested?
- local vibration apply
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 45-75 years old diagnosed with stroke
- Being diagnosed with ischemic or hemorrhagic stroke,
- Not having cooperation and communication problems,
- Stroke individuals with gastrosoleus spasticity, those with a MAS score of 2 or below,
- Those who score 0-3 on the Modified Rankin Scale.
- People weighing less than 150 kilos
- Patients who can walk independently (with an assisted device if they use an assistive device)
Who cannot join
- Have undergone surgery or botox for spasticity in the last 6 months,
- Those with joint contracture,
- Having a neurological disease other than stroke that may affect the patient's ability to walk and stand independently, or having pain in the lower extremity joints and a history of fractures in the lower extremities in the last 6 months,
- Having spasticity that prevents sole contact
- Patients who do not agree to participate in the study and do not give written consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Kırıkkale University
Kirikkale
Saniye Aydoğan Arslan, Assoc. Prof, +905053333457, fztsaniye1982@gmail.com
Kübra Uğurlu, Msc
- Not yet recruiting
Kırıkkale University
Kirikkale
Saniye Aydoğan Arslan, Assoc. Prof, +903183573738, fztsaniye1982@gmail.com
Kübra Uğurlu, PT
About this study
Official title: Investigation of the Acute Effect of Local Vibration Application on Gait and Balance in Stroke Patients
The aim of the research is to examine the acute effect of local vibration application on gait and balance in stroke patients.
Read the detailed description
The purpose of our study; To examine the acute effect of local vibration application on spatiotemporal parameters of gait and balance in stroke patients.
Many treatment approaches are applied to accelerate motor recovery in stroke rehabilitation. These treatment approaches include Neurodevelopmental Therapy (NGT) treatment approaches and electrotherapy, traditional exercise approaches, as well as new technologies such as robotic devices and virtual reality, which offer new opportunities to increase training intensity by providing a more independent training in the field of rehabilitation. Another treatment approach that has recently attracted attention in neurorehabilitation is local or whole body vibration application. Vibration is defined as "a mechanical stimulus characterized by oscillatory movements". When vibration is viewed biomechanically, it has 3 parameters. These parameters; It is defined as the amplitude that determines the oscillation range of the vibration in millimeters, the frequency that indicates the number of repetitions in one second, and the power given by the acceleration that occurs during vibration.
Vibration can be applied to humans in two basic ways. The first method is local vibration application, which can be applied directly to the muscle or tendon with a hand-held device. The second method, called whole body vibration, is applied on the platform by a vibration source. Vibration applications in physiotherapy are generally 0.1-10 mm amplitude, 10-120 Hz. It is used in frequency and duration from 5 seconds to 60 minutes for up to 72 weeks. In whole body vibration, the degree of acceleration created by the platform surface can create a force up to 17 times the acceleration of gravity.
Wanderley et al. In their study, they applied vibration with a frequency of 100 Hz and an amplitude of 2 mm under the sole of the foot to female patients aged 60 and over with balance problems in 12 sessions of 10-minute applications for 5 weeks. As a result, they reported that vibration stimulation applied to the plantar region had positive effects on postural control and balance in women aged 60 and over with balance problems. In another study, Soffia Naghdi et al. In their case report, they reported that applying 100 Hz frequency plantar vibration to the sole of the foot of a right hemiplegic patient for 5 minutes was effective in balance development. Local vibration, in addition to the general physiotherapy and rehabilitation program, can improve walking performance in patients secondary to chronic stroke. The authors hypothesize that this could possibly be due to mechanical vibration stimulating the brain and reorganizing it. Additionally, the results of another study support this study. It has been shown that after applying low-amplitude local vibration to the flexor carpi radialis muscle and the intrinsic hand muscles of healthy individuals, there is increased excitability in the primary motor cortex area of the stimulated muscle.
When we examined the literature, we could not find any studies investigating the effect of local vibration applications to the gastrocnemius on spatiotemporal parameters and balance of walking in individuals with stroke.
- Being tested
- local vibration apply
- Keywords
- local vibration, stroke, gait, balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local vibration applyDevice
Local vibration (LV) application will be made with the Vibrasens© (Techno Concept, Mane, France) device. Vibrasens© is a mechanical vibrator that produces transcutaneous vibration stimulations used in sensory-motor rehabilitation. Vibrasens©; It is a non-invasive, therapeutic device. Vibrasens© includes 1 pilot unit, 1 manual vibrator VB200, 4 flat skin contactors for tendon application, 4 round skin contactors for skin application, 1 power supply, 1 user manual and 1 protocol guide. LV application will be applied to the most swollen part of the spastic medial gastrocnemius muscles in the treatment group for 10 minutes. LV will be applied to one of the treatment groups at a frequency of 80Hz with an amplitude of 1 mm.
| Study group | Role | What they receive |
|---|---|---|
| local vibration apply group | Experimental | Local vibration (LV) application will be made with the Vibrasens© (Techno Concept, Mane, France) device. It will be applied to the most swollen part of the spastic medial gastrocnemius muscles for 10 minutes. LV will be applied to one of the treatment groups at a frequency of 80Hz with an amplitude of 1 mm. Receives: Device: local vibration apply |
| placebo group | Placebo comparator | The device will be contacted to the same areas of the patients in the vibration group for only 10 minutes. Receives: Device: local vibration apply |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
This scale is a reliable and valid scale that is widely used in the evaluation of muscle tone. Resistance to passive movement is rated from 0 to 4.
Measured: 5 minutes
Timed Up and Go Test
It will be applied for mobility and fall risk. This test will be performed by measuring the time taken by the individual to get up from the chair without arm support after giving the "go" command while sitting in a chair, walking 3 meters in a pre-determined area, turning around and sitting on the chair again without using his or her arms.
Measured: 5 minutes
Functional Reaching Test
The patient raises his dominant arm 90 degrees, makes a fist, and reaches forward as far as he can to follow the measuring rod placed at shoulder level. Reaching distance is recorded. It is a reliable test with normal values. 15cm and 15cm. Below 15 to 25 cm the risk of falling increases significantly. indicates a moderate fall risk
Measured: 5 Minutes
Biodex Computerized Balance System
Individuals' postural control will be evaluated with the Biodex Computerized Balance System. The Biodex Computerized Balance System is a multi-axis device that objectively measures and records an individual's ability to stabilize the relevant joint under dynamic stress. Postural stability test and Fall Risk Test will be performed using two different tests. Postural stability testing evaluates static balance in a standing position. The amount of deviation from the medial-lateral and anterior-posterior axes is calculated as a result of the test. According to these deviation values, general instability index, anterior-posterior stability index and medial-lateral stability index scores are obtained. A fall risk test is a test that objectively evaluates the risk of falling. The reactions of the body according to the changing ground structure are detected and recorded and a value is obtained as a result of the test.
Measured: 5 minutes
Tandem Stance
The test is a test that evaluates static balance in which the area in contact with the ground is narrowed. It is generally preferred in patients who cannot stand on one leg. The patient is asked to stand without support for 30 seconds, with the tip of one foot touching the heel of the other foot. Stopping for less than 10 seconds indicates the risk of falling.
Measured: 5 minutes
10 Meter Walking Test
The 10 meter walk test (10MYT) will be used to measure walking speed. 10MYT is a reliable and valid measurement for measuring walking speed in people who have had a stroke. In this test, the person is asked to walk at his/her normal speed in a pre-measured 10-meter area (if he/she uses a walking aid, it is carried out together with this). The time starts when the person's foot is at the starting line and ends when they cross the finish line. Two measurements are made and the best value is recorded in meters per second (m/s).
Measured: 5 minutes
Gait Analysis
Spatiotemporal parameters of gait will be evaluated using a wireless miniature digital gait analysis system. Gait analysis system is a device that is attached to the person's L5-S1 level with the help of a belt and performs movement analysis in the anteroposterior, mediolateral and superoinferior axes via accelerometer. It transfers the obtained data to the computer via Bluetooth. Sensor: The device is placed in the pelvis at the L5-S1 level over a thin, single layer of clothing. The evaluation will be carried out in a calm environment, with bare feet. Gait parameters evaluated: right and left step lengths, double step length, step width, walking tempo (steps per minute), walking speed and foot angle, pelvic oscillation.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Jan 2025
- Primary completion1 Nov 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Effect of Local Vibration Application in 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saniye Aydoğan Arslan, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610994
- Sponsor's protocol ID
- LocalVibrationStroke
- Status last verified
- Nov 2024
- First submitted
- 29 May 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ayvat F, Ozcakar L, Ayvat E, Aksu Yildirim S, Kilinc M. Effects of low vs. high frequency local vibration on mild-moderate muscle spasticity: Ultrasonographical and functional evaluation in patients with multiple sclerosis. Mult Scler Relat Disord. 2021 Jun;51:102930. doi: 10.1016/j.msard.2021.102930. Epub 2021 Mar 31.
PubMed 33836458Alashram AR, Padua E, Romagnoli C, Annino G. Effectiveness of focal muscle vibration on hemiplegic upper extremity spasticity in individuals with stroke: A systematic review. NeuroRehabilitation. 2019 Dec 18;45(4):471-481. doi: 10.3233/NRE-192863.
PubMed 31868686Khalifeloo M, Naghdi S, Ansari NN, Akbari M, Jalaie S, Jannat D, Hasson S. A study on the immediate effects of plantar vibration on balance dysfunction in patients with stroke. J Exerc Rehabil. 2018 Apr 26;14(2):259-266. doi: 10.12965/jer.1836044.022. eCollection 2018 Apr.
PubMed 29740561
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Acute Effect of Local Vibration Application on Gait and Balance in Stroke Patients
- ClinicalTrials.gov ID
- NCT06610994
- Acronym / sponsor ID
- LocalVibrationStroke
- Keywords
- local vibration, stroke, gait, balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 24 Sep 2024 (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 the research is to examine the acute effect of local vibration application on gait and balance in stroke patients.
Detailed description
The purpose of our study; To examine the acute effect of local vibration application on spatiotemporal parameters of gait and balance in stroke patients.
Many treatment approaches are applied to accelerate motor recovery in stroke rehabilitation. These treatment approaches include Neurodevelopmental Therapy (NGT) treatment approaches and electrotherapy, traditional exercise approaches, as well as new technologies such as robotic devices and virtual reality, which offer new opportunities to increase training intensity by providing a more independent training in the field of rehabilitation. Another treatment approach that has recently attracted attention in neurorehabilitation is local or whole body vibration application. Vibration is defined as "a mechanical stimulus characterized by oscillatory movements". When vibration is viewed biomechanically, it has 3 parameters. These parameters; It is defined as the amplitude that determines the oscillation range of the vibration in millimeters, the frequency that indicates the number of repetitions in one second, and the power given by the acceleration that occurs during vibration.
Vibration can be applied to humans in two basic ways. The first method is local vibration application, which can be applied directly to the muscle or tendon with a hand-held device. The second method, called whole body vibration, is applied on the platform by a vibration source. Vibration applications in physiotherapy are generally 0.1-10 mm amplitude, 10-120 Hz. It is used in frequency and duration from 5 seconds to 60 minutes for up to 72 weeks. In whole body vibration, the degree of acceleration created by the platform surface can create a force up to 17 times the acceleration of gravity.
Wanderley et al. In their study, they applied vibration with a frequency of 100 Hz and an amplitude of 2 mm under the sole of the foot to female patients aged 60 and over with balance problems in 12 sessions of 10-minute applications for 5 weeks. As a result, they reported that vibration stimulation applied to the plantar region had positive effects on postural control and balance in women aged 60 and over with balance problems. In another study, Soffia Naghdi et al. In their case report, they reported that applying 100 Hz frequency plantar vibration to the sole of the foot of a right hemiplegic patient for 5 minutes was effective in balance development. Local vibration, in addition to the general physiotherapy and rehabilitation program, can improve walking performance in patients secondary to chronic stroke. The authors hypothesize that this could possibly be due to mechanical vibration stimulating the brain and reorganizing it. Additionally, the results of another study support this study. It has been shown that after applying low-amplitude local vibration to the flexor carpi radialis muscle and the intrinsic hand muscles of healthy individuals, there is increased excitability in the primary motor cortex area of the stimulated muscle.
When we examined the literature, we could not find any studies investigating the effect of local vibration applications to the gastrocnemius on spatiotemporal parameters and balance of walking in individuals with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local vibration apply group | Experimental | Device: local vibration applyLocal vibration (LV) application will be made with the Vibrasens© (Techno Concept, Mane, France) device. It will be applied to the most swollen part of the spastic medial gastrocnemius muscles for 10 minutes. LV will be applied to one of the treatment groups at a frequency of 80Hz with an amplitude of 1 mm. |
| placebo group | Placebo comparator | Device: local vibration applyThe device will be contacted to the same areas of the patients in the vibration group for only 10 minutes. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 45-75 years old diagnosed with stroke
- Being diagnosed with ischemic or hemorrhagic stroke,
- Not having cooperation and communication problems,
- Stroke individuals with gastrosoleus spasticity, those with a MAS score of 2 or below,
- Those who score 0-3 on the Modified Rankin Scale.
Key exclusion criteria (5 listed)
- Have undergone surgery or botox for spasticity in the last 6 months,
- Those with joint contracture,
- Having a neurological disease other than stroke that may affect the patient's ability to walk and stand independently, or having pain in the lower extremity joints and a history of fractures in the lower extremities in the last 6 months,
- Having spasticity that prevents sole contact
- Patients who do not agree to participate in the study and do not give written consent
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 |
|---|---|---|
| local vibration applyLocal vibration (LV) application will be made with the Vibrasens© (Techno Concept, Mane, France) device. Vibrasens© is a mechanical vibrator that produces transcutaneous vibration stimulations used in sensory-motor rehabilitation. Vibrasens©; It is a non-invasive, therapeutic device. Vibrasens© includes 1 pilot unit, 1 manual vibrator VB200, 4 flat skin contactors for tendon application, 4 round skin contactors for skin application, 1 power supply, 1 user manual and 1 protocol guide. LV application will be applied to the most swollen part of the spastic medial gastrocnemius muscles in the treatment group for 10 minutes. LV will be applied to one of the treatment groups at a frequency of 80Hz with an amplitude of 1 mm. | Device | local vibration apply group, placebo group |
Primary outcome
Modified Ashworth Scale
Time frame: 5 minutes
This scale is a reliable and valid scale that is widely used in the evaluation of muscle tone. Resistance to passive movement is rated from 0 to 4.
Timed Up and Go Test
Time frame: 5 minutes
It will be applied for mobility and fall risk. This test will be performed by measuring the time taken by the individual to get up from the chair without arm support after giving the "go" command while sitting in a chair, walking 3 meters in a pre-determined area, turning around and sitting on the chair again without using his or her arms.
Functional Reaching Test
Time frame: 5 Minutes
The patient raises his dominant arm 90 degrees, makes a fist, and reaches forward as far as he can to follow the measuring rod placed at shoulder level. Reaching distance is recorded. It is a reliable test with normal values. 15cm and 15cm. Below 15 to 25 cm the risk of falling increases significantly. indicates a moderate fall risk
Biodex Computerized Balance System
Time frame: 5 minutes
Individuals' postural control will be evaluated with the Biodex Computerized Balance System. The Biodex Computerized Balance System is a multi-axis device that objectively measures and records an individual's ability to stabilize the relevant joint under dynamic stress. Postural stability test and Fall Risk Test will be performed using two different tests. Postural stability testing evaluates static balance in a standing position. The amount of deviation from the medial-lateral and anterior-posterior axes is calculated as a result of the test. According to these deviation values, general instability index, anterior-posterior stability index and medial-lateral stability index scores are obtained. A fall risk test is a test that objectively evaluates the risk of falling. The reactions of the body according to the changing ground structure are detected and recorded and a value is obtained as a result of the test.
Tandem Stance
Time frame: 5 minutes
The test is a test that evaluates static balance in which the area in contact with the ground is narrowed. It is generally preferred in patients who cannot stand on one leg. The patient is asked to stand without support for 30 seconds, with the tip of one foot touching the heel of the other foot. Stopping for less than 10 seconds indicates the risk of falling.
10 Meter Walking Test
Time frame: 5 minutes
The 10 meter walk test (10MYT) will be used to measure walking speed. 10MYT is a reliable and valid measurement for measuring walking speed in people who have had a stroke. In this test, the person is asked to walk at his/her normal speed in a pre-measured 10-meter area (if he/she uses a walking aid, it is carried out together with this). The time starts when the person's foot is at the starting line and ends when they cross the finish line. Two measurements are made and the best value is recorded in meters per second (m/s).
Gait Analysis
Time frame: 10 minutes
Spatiotemporal parameters of gait will be evaluated using a wireless miniature digital gait analysis system. Gait analysis system is a device that is attached to the person's L5-S1 level with the help of a belt and performs movement analysis in the anteroposterior, mediolateral and superoinferior axes via accelerometer. It transfers the obtained data to the computer via Bluetooth. Sensor: The device is placed in the pelvis at the L5-S1 level over a thin, single layer of clothing. The evaluation will be carried out in a calm environment, with bare feet. Gait parameters evaluated: right and left step lengths, double step length, step width, walking tempo (steps per minute), walking speed and foot angle, pelvic oscillation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Results publication: PubMed 33836458Ayvat F, Ozcakar L, Ayvat E, Aksu Yildirim S, Kilinc M. Effects of low vs. high frequency local vibration on mild-moderate muscle spasticity: Ultrasonographical and functional evaluation in patients with multiple sclerosis. Mult Scler Relat Disord. 2021 Jun;51:102930. doi: 10.1016/j.msard.2021.102930. Epub 2021 Mar 31.
- Results publication: PubMed 31868686Alashram AR, Padua E, Romagnoli C, Annino G. Effectiveness of focal muscle vibration on hemiplegic upper extremity spasticity in individuals with stroke: A systematic review. NeuroRehabilitation. 2019 Dec 18;45(4):471-481. doi: 10.3233/NRE-192863.
- Results publication: PubMed 29740561Khalifeloo M, Naghdi S, Ansari NN, Akbari M, Jalaie S, Jannat D, Hasson S. A study on the immediate effects of plantar vibration on balance dysfunction in patients with stroke. J Exerc Rehabil. 2018 Apr 26;14(2):259-266. doi: 10.12965/jer.1836044.022. eCollection 2018 Apr.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local vibration apply in people with Acute Effect of Local Vibration Application in Stroke Patients, run by Kırıkkale University at 2 sites 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saniye Aydoğan Arslan, Assoc Prof (+905053333457, fztsaniye1982@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (time frame: 5 minutes). The study lists 7 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 NCT06610994, which also lists 3 linked publications.
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 11 Mar 2025.