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

NCT07286435 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-16

No results posted yet for this 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.

Conditions

  • Stroke Gait Rehabilitation

Interventions

DEVICE

Whole 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.

DEVICE

Sham 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.

Sponsors & Collaborators

  • Uludag University

    lead OTHER

Principal Investigators

  • Sevda Demir Ture · Uludag University

  • Alev Alp · Uludag University

  • Emel Oguz Akarsu · Uludag University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-09-30
Completion
2026-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07286435 on ClinicalTrials.gov