Whole-Body Vibration After BoNT-A for Ankle Spasticity in Stroke
Official title: The Effect of Whole-Body Vibration Therapy Following Botulinum Toxin A Injection on Spasticity and Balance in Stroke Patients
Run by Uludag University · NCT07286435 · Data updated 2026-11-12
This study tests whether adding whole-body vibration after botulinum toxin A injections improves ankle spasticity and balance in stroke patients who can walk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Uludag University Academic / other |
| Locations | 1 site (Bursa, Bursa) |
| Status | Recruiting |
| Started | January 5, 2026 |
| Main results expected | June 2027 |
| Study ends | December 2027 |
| Registry record updated | September 3, 2026 |
| Trial ID | NCT07286435 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18-75 with unilateral stroke, ankle MAS ≥2, able to walk 100 meters, MMSE ≥24, and no contraindicating implants or severe comorbidities.
✕Probably not a fit
Patients with severe cognitive impairment, non-ambulatory status, significant joint disease, recent lower-extremity fracture, or active contraindications to vibration therapy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized, double-masked trial, 50 stroke patients with ankle spasticity scheduled for BoNT-A injections will be assigned to either a whole-body vibration therapy or a sham vibration. All participants receive BoNT-A to the gastrosoleus muscles, and two weeks later they undergo the assigned vibration protocol to assess changes in spasticity, balance, and walking ability. The study compares adjuvant WBV to a vibration-free control to determine if WBV enhances outcomes after BoNT-A. Demographic and clinical data, including stroke type, hemisphere involvement, comorbidities, and antispastic medications, are collected to describe the study population. Primary endpoints focus on spasticity reduction and functional balance, with secondary outcomes relating to gait performance.
Why it matters
Potential benefit: If successful, WBV after BoNT-A could offer an accessible way to improve spasticity management and gait in stroke survivors.
How similar studies have gone: Prior research in similar post-stroke rehab contexts suggests potential benefit from WBV, but specific post-BoNT-A adjuvant use remains investigational.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 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 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
Where it's running
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Bursa Uludağ University Faculty of Medicine
Bursa, Bursa, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Sevda Demir Ture — Uludag University
- Study coordinator: Sevda Demir Demir Ture, MD, Spacialist Physician
- Email: sevdademir.ftr@gmail.com
- Phone: +905414354785
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Optimizing Gait Rehabilitation After Stroke
This study tests a virtual-reality breathing? (VR) feedback tool to improve arm swing and walking balance for people who recently had a stroke.
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VNS with Rehab to Improve Gait After Stroke
This study tests whether adding vagus nerve stimulation to gait rehabilitation helps stroke survivors improve walking.
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Split-belt treadmill dosing for early stroke recovery
This program will test how much split-belt treadmill walking with virtual reality people in the first three months after a stroke can safely tolerate.
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Robotic balance training with brain stimulation to improve balance after stroke
This program tests whether adding noninvasive brain stimulation to robotic balance training helps people with chronic stroke who still have balance and walking problems.
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MINT Conditioning to Improve Gait
A myoelectric interface training is being tested to see if it can help adults with leg weakness from stroke walk better.
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Robotic-assisted walking therapy for people in the subacute phase of stroke
This trial will test whether adding robotic-assisted gait training to regular physical therapy helps people 1 to 3 months after a stroke improve their walking and daily function.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.