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

Sponsor: Uludag University • ClinicalTrials.gov ID: NCT07286435

Registry updated: 2026-09-03

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Description

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.

Interventions

Whole body vibration therapy (Device)
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 therapy (Device)
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.

Eligibility 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

Conditions

Stroke Gait Rehabilitation

Locations

Bursa Uludağ University Faculty of Medicine — Bursa, Bursa, Turkey (Türkiye)

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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