ClinicalTrials.gg
RecruitingNCT07286435Updated Sep 3, 2026

The Effect of Whole-Body Vibration Therapy Following Botulinum Toxin A Injection on Spasticity and Balance in Stroke Patients

An interventional study of Whole body vibration therapy and Sham whole body vibration therapy in Stroke Gait Rehabilitation, sponsored by Uludag University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Uludag University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 484 studies in Stroke with a site in Turkey — 95 open to participants now, 107 under way, 3 of them phase 3. Stroke · Turkey.

Planned enrollment
104th of 320
50 · median 40
Started
2026
with 60 others
No phase
291 of 484
57 open now
Primary completion
2027-06
later than 90 of 106 live
Registered
392nd of 484
by date

Among the 484 studies in Stroke with a site in Turkey, this one is the 104th largest by planned enrollment of the 320 interventional ones, is one of 61 that started in 2026, is one of 291 with no phase, reaches primary completion later than 90 of the 106 other live ones, and was the 392nd registered.

By phase

484 studies; the count open now beside each. This study's row is marked.

No phasethis study291 · 57 open
Observational164 · 36 open
Phase 325 · 1 open
Phase 43 · 1 open
Phase 11 · 0 open

By the year they started

First in 1998; this study’s year is marked. 61 started in 2026.

Size and results

Median enrollment 40 across the 320 interventional studies, 63 across the 164 observational. Of the 338 that completed or were terminated, 22 (7%) have results posted.

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02

Study 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. 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.

03

Conditions studied

  • Stroke Gait Rehabilitation

Keywords

  • stroke, whole body vibration, spasticity, balance
  • gait
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 (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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    The intervention group

    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.

    Device: Whole body vibration therapy

  • Sham comparator
    The control group

    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.

    Device: Sham whole body vibration therapy

Interventions

  • DeviceWhole body vibration therapy

    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.

  • DeviceSham whole body vibration therapy

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: "From enrollment to the end of treatment at 12 weeks"

  2. 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.

    Time frame: From enrollment to the end of treatment at 12 weeks

  3. 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

    Time frame: From enrollment to the end of treatment at 12 weeks

  4. 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.

    Time frame: From enrollment to the end of treatment at 8 weeks

  5. 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.

    Time frame: From enrollment to the end of treatment at 12 weeks

Secondary outcomes

  1. 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.

    Time frame: From enrollment to the end of treatment at 12 weeks

  2. 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.

    Time frame: From enrollment to the end of treatment at 12 weeks

  3. 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.

    Time frame: From enrollment to the end of treatment at 12 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 30219307 ↗
  • Paoloni 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 23543344 ↗
  • Chan 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Jun 2027, 17 months after the start.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 17 months is below that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 2, 2025
First posted
Dec 16, 2025
StartActual
Jan 5, 2026
Primary completionEst.
Jun 2027
CompletionEst.
Dec 2027
Last update
Sep 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07286435
Lead sponsor
Uludag University
Responsible party
Sevda Demir Türe (Specialist in Physical Medicine and Rehabilitation, Uludag University) — Principal investigator
First posted
Dec 16, 2025
Start date
Jan 5, 2026
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 3, 2026

Study contacts

Sevda Demir Demir Ture, MD, Spacialist Physician
Contact
sevdademir.ftr@gmail.com
+905414354785
Alev Alp, MD, Prof. Dr.
Contact
dr.alevalp@gmail.com
+905422540133
Sevda Demir Ture
principal investigator · Uludag University
Alev Alp
principal investigator · Uludag University
Emel Oguz Akarsu
principal investigator · Uludag University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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