Stroke Gait RehabilitationNCT07286435
The Effect of Whole-Body Vibration Therapy Following Botulinum Toxin A Injection on Spasticity and Balance in Stroke Patients
A study testing Whole body vibration therapy in people with Stroke Gait Rehabilitation, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this clinical study is to evaluate the effect of Whole Body Vibration (WBV) therapy, applied two weeks after botulinum toxin type A (BoNT-A) injection, on spasticity and balance parameters in individuals with stroke who have ankle spasticity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke Gait Rehabilitation
- What is being tested?
- Whole body vibration therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2026to Dec 2027
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with unilateral hemiparesis due to hemorrhage or infarction
- Participants aged 18-75 years
- Participants with MAS ≥2 spasticity in the ankle
- Participants with a Mini-Mental State Examination (MMSE) score of 24, indicating preserved cognitive and communication abilities
- Participants who can walk at least 100 meters with or without assistive devices
- Participants without joint contractures and with sufficient motor control to perform functional walking tests
- Participants who have not previously undergone vibration therapy
Who cannot join
- History of neurological disease (such as polyneuropathy or motor neuron diseases) other than a history of existing stroke
- History of recent fracture in the lower extremity
- Severe degenerative joint disease
- History of implants in the lower extremity or spine
- History of cardiac pacemakers
- Presence of uncontrolled hypertension and uncontrolled diabetes
- History of recent thromboembolism or infection
- Participants whose antispasmodic medication regimen was changed within 1 month prior to starting treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa Uludağ University Faculty of Medicine
Bursa, Bursa, 16235
Sevda Demir, M.D., 05414354785, sevdademir.ftr@gmail.com
About this study
The purpose of this clinical study is to evaluate the effect of Whole Body Vibration (WBV) therapy, applied two weeks after botulinum toxin type A (BoNT-A) injection, on spasticity and balance parameters in individuals with stroke who have ankle spasticity. The main questions it aims to answer are: Adjuvant WBV therapy administered after BoNT-A injection;
- Does it effectively improve spasticity?
- Is it an effective intervention for balance and walking functions? Researchers will compare the application of WBV to a placebo application (a vibration-free application) to evaluate the effect of adjuvant WBV therapy administered after BoNT-A injection on ankle spasticity, balance, and walking function in individuals with stroke.
Read the detailed description
Materials and Methods:
Stroke participants who applied to the outpatient clinic of the Department of Physical Medicine and Rehabilitation at Uludağ University Faculty of Medicine and were evaluated at the rehabilitation council due to ankle spasticity, and for whom BoNT-A injection therapy was planned for the gastrosoleus muscles, will be evaluated for study eligibility. The study will include a total of 50 participants who meet the inclusion criteria. Participants to be included in the study will be randomly assigned to 2 groups, with 25 participants in each group, using computer-generated randomization. The study was planned as a prospective, double-masked, randomized controlled clinical study.
Informed consent will be obtained from participants who meet the inclusion criteria. Participants' demographic data (age, gender, height, and weight), stroke type (ischemic/hemorrhagic), side of hemiplegia (right/left), lesion location, comorbidities, pre-stroke functional status, and use of antispastic medication will be recorded.
For all participants who planned to receive BoNT-A injection therapy for ankle spasticity during outpatient clinic visits and who met the study criteria, 100-300 units of BoNT-A injection therapy will be administered to the gastrosoleus muscles by an experienced physical medicine and rehabilitation specialist. Thereafter, participants will be categorized into two groups of 25 individuals each based on a random number table.
- The intervention group will receive the WBV program on a vibration platform in a semi-squat position for 10 minutes, 3 days a week for 4 weeks, with an amplitude of 4 mm and a frequency of 20 Hz. This program will be administered using the 'Compex Winplate' device in the physical therapy room of our hospital's Department of Physical Medicine and Rehabilitation, under the supervision of a physical therapist.
- The control group will receive sham WBV treatment (a vibration-free application) for the same duration.
Both groups will be given a home exercise program consisting of calf muscle stretching and joint range-of-motion exercises, which will be completed for 15 minutes per day throughout the treatment period. The home program consists of stretching exercises for the ankle muscles, which can be performed without the use of additional materials. The participant will be given a pictorial guide after the physiotherapist explains the exercise program.
Study Algorithm: Power analysis was performed using the G*Power 3.1.9.6 program to calculate the sample size. The effect size of the difference between the two groups in terms of the Modified Ashworth Scale, VAS score, H-reflex, and Hmax/Mmax ratio was determined to be 0.80, with Chan et al.'s study serving as a reference. It was determined that at least 25 participants were required in each group to achieve 80% power and a significance level of 5%.
The data will be analyzed using IBM SPSS v. 25 statistical software. The obtained data will be analyzed and compared using appropriate statistical tests.
- Conditions
- Stroke Gait Rehabilitation
- Being tested
- Whole body vibration therapy, Sham whole body vibration therapy
- Keywords
- stroke, whole body vibration, spasticity, balance, gait
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibration therapyDevice
The intervention group will receive WBV program on a vibration platform in a semi-squat position for 10 minutes, 3 days a week for 4 weeks, with an amplitude of 4 mm and a frequency of 20 Hz. This program will be administered using the 'Compex Winplate' device in the physical therapy room of our hospital's Department of Physical Medicine and Rehabilitation, under the supervision of a physical therapist. Both groups will be given a home exercise program consisting of calf muscle stretching and joint range-of-motion exercises, to be completed for 15 minutes per day, throughout the treatment period. The home program consists of stretching exercises for the ankle muscles, which can be performed without the use of additional materials. The participant will be given a pictorial guide after the physiotherapist explains the exercise program.
Sham whole body vibration therapyDevice
The control group will receive sham WBV treatment (a vibration-free application) on a vibration platform in a semi-squat position for 10 minutes, three days a week, for four weeks. This program will be administered using the 'Compex Winplate' device in the physical therapy room of our hospital's Department of Physical Medicine and Rehabilitation, under the supervision of a physical therapist. Both groups will be given a home exercise program consisting of calf muscle stretching and joint range-of-motion exercises, to be completed for 15 minutes per day throughout the treatment period. The participant will be given a pictorial guide after the physiotherapist explains the exercise program.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Active comparator | The intervention group will receive WBV program on a vibration platform in a semi-squat position for 10 minutes, 3 days a week for 4 weeks, with an amplitude of 4 mm and a frequency of 20Hz. This program will be administered using the 'Compex Winplate' device in the physical therapy room of our hospital's Department of Physical Medicine and Rehabilitation, under the supervision of a physical therapist. Both groups will be given a home exercise program consisting of calf muscle stretching and joint range-of-motion exercises, to be completed for 15 minutes per day, throughout the treatment period. The home program consists of stretching exercises for the ankle muscles, which can be performed without the use of additional materials. The participant will be given a pictorial guide after the physiotherapist explains the exercise program. Receives: Device: Whole body vibration therapy |
| The control group | Sham comparator | The control group will receive sham WBV treatment (a vibration-free application) on a vibration platform in a semi-squat position for 10 minutes, three days a week, for four weeks. This program will be administered using the 'Compex Winplate' device in the physical therapy room of our hospital's Department of Physical Medicine and Rehabilitation, under the supervision of a physical therapist. Both groups will be given a home exercise program consisting of calf muscle stretching and joint range-of-motion exercises, to be completed for 15 minutes per day throughout the treatment period. The participant will be given a pictorial guide after the physiotherapist explains the exercise program. Receives: Device: Sham whole body vibration therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the maximum amplitude of the H-reflex, the Hmax/Mmax ratio, and F-wave parameters evaluated with EMNG.
-ENMG evaluation: Initially (0), 2 weeks after BoNT-A injection (Week 2), at the end of WBV treatment (Week 6), and at Week 12, an experienced neurologist will perform EMG to assess ankle spasticity. The maximum amplitude of the H-reflex, the Hmax/Mmax ratio, and F-wave parameters will be measured and recorded
Measured: "From enrollment to the end of treatment at 12 weeks"
Change from Baseline in the static balance and postural stability assessment
Initially (0), 2 weeks after BoNT-A injection (Week 2), at the end of WBV treatment (Week 6), and at Week 12, to assess static balance, participants will be evaluated for anteroposterior and mediolateral sway on both hard and foam surfaces with eyes open and closed using the HUR Smartbalance BTG4 balance platform (HUR-labs Oy, Kokkola, Finland). Additionally, limits of stability (LOS) measurements will be taken, and the results will be recorded.
Measured: From enrollment to the end of treatment at 12 weeks
MAS (Modified Ashworth Scale)
MAS is a muscle tone assessment scale used to evaluate resistance during passive range of motion, requiring no instrumentation, and can be performed quickly. The scale is graded as follows: 0: No increase in muscle tone 1: Slight increase in muscle tone with catching and release or minimal resistance at the end of the range of motion when the affected part(s) are moved in flexion or extension 1+: Slight increase in muscle tone, manifesting as catching, followed by minimal resistance (less than half) for the remainder of the range of motion. 2: There is a marked increase in muscle tone throughout most of the range of motion, but the affected part(s) can still be moved easily. 3: Significant increase in muscle tone, difficulty with passive movement. 4: Affected part(s) fixed in flexion or extension
Measured: From enrollment to the end of treatment at 12 weeks
TUGT (Timed Up and Go Test)
This Test assesses mobility; a chair and a stopwatch are required. The Test is conducted with the participant wearing their regular shoes, and they are allowed to use walking aids if necessary. A 3-meter area is designated in front of the chair. The participant is asked to stand up from the chair, walk a certain distance, and then sit down again. Time will tell the results of the Test.
Measured: From enrollment to the end of treatment at 8 weeks
Berg Balance Scale (BBS)
It is used to assess functional balance and determine fall risk. The Test consists of 14 items. Values between 0 and 4 are given for each item. While 0 represents the worst value, 4 represents the best value. Four points indicate the ability to complete the task independently. The highest score is 56. Scores between 0-20 indicate balance impairment, scores between 21-40 indicate acceptable balance, and scores between 41-56 indicate good balance.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (3)
The Functional Independence Measure (FIM)
The Functional Independence Measure (FIM): indicates an individual's level of independence in daily life activities. It consists of 18 items, including sections on self-care, sphincter control, transfer, mobility, communication, social perception, and cognitive status, with a scoring range of 18-126. It consists of motor (13 items) and cognitive (5 items) subscales. All items will be answered using a 7-point Likert scale. A validity and reliability study in Turkish has been conducted.
Measured: From enrollment to the end of treatment at 12 weeks
The Visual Analog Scale (VAS)
The Visual Analog Scale (VAS): is scored between 0 and 10. 0 represents the absence of spasticity during ambulation, and 10 represents the maximum intensity of spasticity that prevents ambulation.
Measured: From enrollment to the end of treatment at 12 weeks
10 m Walk Test
10 m Walk Test: During the Test, the participant walks at a normal walking speed between two markers 10 meters apart, and the time taken is recorded.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start5 Jan 2026
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (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 Stroke Gait RehabilitationStudies 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
- Single-center, randomized controlled, double-blind, prospective clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Demir Türe, Uludag University
- Investigators
- Sevda Demir Ture, Principal investigator, Uludag UniversityAlev Alp, Principal investigator, Uludag UniversityEmel Oguz Akarsu, Principal investigator, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286435
- Sponsor's protocol ID
- 2025-16/7 and 09.09.2025
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Picelli A, Santamato A, Chemello E, Cinone N, Cisari C, Gandolfi M, Ranieri M, Smania N, Baricich A. Adjuvant treatments associated with botulinum toxin injection for managing spasticity: An overview of the literature. Ann Phys Rehabil Med. 2019 Jul;62(4):291-296. doi: 10.1016/j.rehab.2018.08.004. Epub 2018 Sep 13.
PubMed 30219307Paoloni M, Giovannelli M, Mangone M, Leonardi L, Tavernese E, Di Pangrazio E, Bernetti A, Santilli V, Pozzilli C. Does giving segmental muscle vibration alter the response to botulinum toxin injections in the treatment of spasticity in people with multiple sclerosis? A single-blind randomized controlled trial. Clin Rehabil. 2013 Sep;27(9):803-12. doi: 10.1177/0269215513480956. Epub 2013 Mar 29.
PubMed 23543344Chan KS, Liu CW, Chen TW, Weng MC, Huang MH, Chen CH. Effects of a single session of whole body vibration on ankle plantarflexion spasticity and gait performance in patients with chronic stroke: a randomized controlled trial. Clin Rehabil. 2012 Dec;26(12):1087-95. doi: 10.1177/0269215512446314. Epub 2012 Oct 3.
PubMed 23035004
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whole-Body Vibration Therapy Following Botulinum Toxin A Injection on Spasticity and Balance in Stroke Patients
- ClinicalTrials.gov ID
- NCT07286435
- Acronym / sponsor ID
- 2025-16/7 and 09.09.2025
- Conditions
- Stroke Gait Rehabilitation
- Keywords
- stroke, whole body vibration, spasticity, balance, gait
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Dec 2025 (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 purpose of this clinical study is to evaluate the effect of Whole Body Vibration (WBV) therapy, applied two weeks after botulinum toxin type A (BoNT-A) injection, on spasticity and balance parameters in individuals with stroke who have ankle spasticity. The main questions it aims to answer are: Adjuvant WBV therapy administered after BoNT-A injection;
- Does it effectively improve spasticity?
- Is it an effective intervention for balance and walking functions? Researchers will compare the application of WBV to a placebo application (a vibration-free application) to evaluate the effect of adjuvant WBV therapy administered after BoNT-A injection on ankle spasticity, balance, and walking function in individuals with stroke.
Detailed description
Materials and Methods:
Stroke participants who applied to the outpatient clinic of the Department of Physical Medicine and Rehabilitation at Uludağ University Faculty of Medicine and were evaluated at the rehabilitation council due to ankle spasticity, and for whom BoNT-A injection therapy was planned for the gastrosoleus muscles, will be evaluated for study eligibility. The study will include a total of 50 participants who meet the inclusion criteria. Participants to be included in the study will be randomly assigned to 2 groups, with 25 participants in each group, using computer-generated randomization. The study was planned as a prospective, double-masked, randomized controlled clinical study.
Informed consent will be obtained from participants who meet the inclusion criteria. Participants' demographic data (age, gender, height, and weight), stroke type (ischemic/hemorrhagic), side of hemiplegia (right/left), lesion location, comorbidities, pre-stroke functional status, and use of antispastic medication will be recorded.
For all participants who planned to receive BoNT-A injection therapy for ankle spasticity during outpatient clinic visits and who met the study criteria, 100-300 units of BoNT-A injection therapy will be administered to the gastrosoleus muscles by an experienced physical medicine and rehabilitation specialist. Thereafter, participants will be categorized into two groups of 25 individuals each based on a random number table.
- The intervention group will receive the WBV program on a vibration platform in a semi-squat position for 10 minutes, 3 days a week for 4 weeks, with an amplitude of 4 mm and a frequency of 20 Hz. This program will be administered using the 'Compex Winplate' device in the physical therapy room of our hospital's Department of Physical Medicine and Rehabilitation, under the supervision of a physical therapist.
- The control group will receive sham WBV treatment (a vibration-free application) for the same duration.
Both groups will be given a home exercise program consisting of calf muscle stretching and joint range-of-motion exercises, which will be completed for 15 minutes per day throughout the treatment period. The home program consists of stretching exercises for the ankle muscles, which can be performed without the use of additional materials. The participant will be given a pictorial guide after the physiotherapist explains the exercise program.
Study Algorithm: Power analysis was performed using the G*Power 3.1.9.6 program to calculate the sample size. The effect size of the difference between the two groups in terms of the Modified Ashworth Scale, VAS score, H-reflex, and Hmax/Mmax ratio was determined to be 0.80, with Chan et al.'s study serving as a reference. It was determined that at least 25 participants were required in each group to achieve 80% power and a significance level of 5%.
The data will be analyzed using IBM SPSS v. 25 statistical software. The obtained data will be analyzed and compared using appropriate statistical tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Single-center, randomized controlled, double-blind, prospective clinical trial
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Active comparator | Device: Whole body vibration therapyThe intervention group will receive WBV program on a vibration platform in a semi-squat position for 10 minutes, 3 days a week for 4 weeks, with an amplitude of 4 mm and a frequency of 20Hz. This program will be administered using the 'Compex Winplate' device in the physical therapy room of our hospital's Department of Physical Medicine and Rehabilitation, under the supervision of a physical therapist. Both groups will be given a home exercise program consisting of calf muscle stretching and joint range-of-motion exercises, to be completed for 15 minutes per day, throughout the treatment period. The home program consists of stretching exercises for the ankle muscles, which can be performed without the use of additional materials. The participant will be given a pictorial guide after the physiotherapist explains the exercise program. |
| The control group | Sham comparator | Device: Sham whole body vibration therapyThe control group will receive sham WBV treatment (a vibration-free application) on a vibration platform in a semi-squat position for 10 minutes, three days a week, for four weeks. This program will be administered using the 'Compex Winplate' device in the physical therapy room of our hospital's Department of Physical Medicine and Rehabilitation, under the supervision of a physical therapist. Both groups will be given a home exercise program consisting of calf muscle stretching and joint range-of-motion exercises, to be completed for 15 minutes per day throughout the treatment period. The participant will be given a pictorial guide after the physiotherapist explains the exercise program. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants with unilateral hemiparesis due to hemorrhage or infarction
- Participants aged 18-75 years
- Participants with MAS ≥2 spasticity in the ankle
- Participants with a Mini-Mental State Examination (MMSE) score of 24, indicating preserved cognitive and communication abilities
- Participants who can walk at least 100 meters with or without assistive devices
Key exclusion criteria (8 listed)
- History of neurological disease (such as polyneuropathy or motor neuron diseases) other than a history of existing stroke
- History of recent fracture in the lower extremity
- Severe degenerative joint disease
- History of implants in the lower extremity or spine
- History of cardiac pacemakers
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 therapyThe intervention group will receive WBV program on a vibration platform in a semi-squat position for 10 minutes, 3 days a week for 4 weeks, with an amplitude of 4 mm and a frequency of 20 Hz. This program will be administered using the 'Compex Winplate' device in the physical therapy room of our hospital's Department of Physical Medicine and Rehabilitation, under the supervision of a physical therapist. Both groups will be given a home exercise program consisting of calf muscle stretching and joint range-of-motion exercises, to be completed for 15 minutes per day, throughout the treatment period. The home program consists of stretching exercises for the ankle muscles, which can be performed without the use of additional materials. The participant will be given a pictorial guide after the physiotherapist explains the exercise program. | Device | The intervention group |
| Sham whole body vibration therapyThe control group will receive sham WBV treatment (a vibration-free application) on a vibration platform in a semi-squat position for 10 minutes, three days a week, for four weeks. This program will be administered using the 'Compex Winplate' device in the physical therapy room of our hospital's Department of Physical Medicine and Rehabilitation, under the supervision of a physical therapist. Both groups will be given a home exercise program consisting of calf muscle stretching and joint range-of-motion exercises, to be completed for 15 minutes per day throughout the treatment period. The participant will be given a pictorial guide after the physiotherapist explains the exercise program. | Device | The control group |
Primary outcome
Change from baseline in the maximum amplitude of the H-reflex, the Hmax/Mmax ratio, and F-wave parameters evaluated with EMNG.
Time frame: "From enrollment to the end of treatment at 12 weeks"
-ENMG evaluation: Initially (0), 2 weeks after BoNT-A injection (Week 2), at the end of WBV treatment (Week 6), and at Week 12, an experienced neurologist will perform EMG to assess ankle spasticity. The maximum amplitude of the H-reflex, the Hmax/Mmax ratio, and F-wave parameters will be measured and recorded
Change from Baseline in the static balance and postural stability assessment
Time frame: From enrollment to the end of treatment at 12 weeks
Initially (0), 2 weeks after BoNT-A injection (Week 2), at the end of WBV treatment (Week 6), and at Week 12, to assess static balance, participants will be evaluated for anteroposterior and mediolateral sway on both hard and foam surfaces with eyes open and closed using the HUR Smartbalance BTG4 balance platform (HUR-labs Oy, Kokkola, Finland). Additionally, limits of stability (LOS) measurements will be taken, and the results will be recorded.
MAS (Modified Ashworth Scale)
Time frame: From enrollment to the end of treatment at 12 weeks
MAS is a muscle tone assessment scale used to evaluate resistance during passive range of motion, requiring no instrumentation, and can be performed quickly. The scale is graded as follows: 0: No increase in muscle tone 1: Slight increase in muscle tone with catching and release or minimal resistance at the end of the range of motion when the affected part(s) are moved in flexion or extension 1+: Slight increase in muscle tone, manifesting as catching, followed by minimal resistance (less than half) for the remainder of the range of motion. 2: There is a marked increase in muscle tone throughout most of the range of motion, but the affected part(s) can still be moved easily. 3: Significant increase in muscle tone, difficulty with passive movement. 4: Affected part(s) fixed in flexion or extension
TUGT (Timed Up and Go Test)
Time frame: From enrollment to the end of treatment at 8 weeks
This Test assesses mobility; a chair and a stopwatch are required. The Test is conducted with the participant wearing their regular shoes, and they are allowed to use walking aids if necessary. A 3-meter area is designated in front of the chair. The participant is asked to stand up from the chair, walk a certain distance, and then sit down again. Time will tell the results of the Test.
Berg Balance Scale (BBS)
Time frame: From enrollment to the end of treatment at 12 weeks
It is used to assess functional balance and determine fall risk. The Test consists of 14 items. Values between 0 and 4 are given for each item. While 0 represents the worst value, 4 represents the best value. Four points indicate the ability to complete the task independently. The highest score is 56. Scores between 0-20 indicate balance impairment, scores between 21-40 indicate acceptable balance, and scores between 41-56 indicate good balance.
3 secondary outcomes
The Functional Independence Measure (FIM)
Time frame: From enrollment to the end of treatment at 12 weeks
The Visual Analog Scale (VAS)
Time frame: From enrollment to the end of treatment at 12 weeks
10 m Walk Test
Time frame: From enrollment to the end of treatment at 12 weeks
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 3 Sep 2026.
- Background: PubMed 30219307Picelli A, Santamato A, Chemello E, Cinone N, Cisari C, Gandolfi M, Ranieri M, Smania N, Baricich A. Adjuvant treatments associated with botulinum toxin injection for managing spasticity: An overview of the literature. Ann Phys Rehabil Med. 2019 Jul;62(4):291-296. doi: 10.1016/j.rehab.2018.08.004. Epub 2018 Sep 13.
- Background: PubMed 23543344Paoloni M, Giovannelli M, Mangone M, Leonardi L, Tavernese E, Di Pangrazio E, Bernetti A, Santilli V, Pozzilli C. Does giving segmental muscle vibration alter the response to botulinum toxin injections in the treatment of spasticity in people with multiple sclerosis? A single-blind randomized controlled trial. Clin Rehabil. 2013 Sep;27(9):803-12. doi: 10.1177/0269215513480956. Epub 2013 Mar 29.
- Background: PubMed 23035004Chan KS, Liu CW, Chen TW, Weng MC, Huang MH, Chen CH. Effects of a single session of whole body vibration on ankle plantarflexion spasticity and gait performance in patients with chronic stroke: a randomized controlled trial. Clin Rehabil. 2012 Dec;26(12):1087-95. doi: 10.1177/0269215512446314. Epub 2012 Oct 3.
- Individual participant dataSharing planned: Undecided
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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.
Sevda Demir Ture principal investigator
Uludag University
Alev Alp principal investigator
Uludag University
Emel Oguz Akarsu principal investigator
Uludag 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 therapy in people with Stroke Gait Rehabilitation, run by Uludag 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 7 inclusion and 8 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 3 Sep 2026. 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. 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 Sevda Demir Demir Ture, MD, Spacialist Physician (+905414354785, sevdademir.ftr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the maximum amplitude of the H-reflex, the Hmax/Mmax ratio, and F-wave parameters evaluated with EMNG. (time frame: "From enrollment to the end of treatment at 12 weeks"). The study lists 5 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 NCT07286435, 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 3 Sep 2026.