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NCT07286435
The Effect of Whole-Body Vibration Therapy Following Botulinum Toxin A Injection on Spasticity and Balance in Stroke Patients
Conditions: Stroke Gait Rehabilitation
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Uludag University
Location: Bursa Uludağ University Faculty of Medicine Bursa Bursa
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.
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
Source: ClinicalTrials.gov (NCT07286435). StuddyBuddy aggregates publicly available trial information.