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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 jo
• Устройство 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-o

Первичные конечные точки

• Change from baseline in the maximum amplitude of the H-reflex, the Hmax/Mmax ratio, and F-wave parameters evaluated with EMNG. [Срок оценки: "From enrollment to the end of treatment at 12 weeks"]
• Change from Baseline in the static balance and postural stability assessment [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• MAS (Modified Ashworth Scale) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• TUGT (Timed Up and Go Test) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Berg Balance Scale (BBS) [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (3)

• The Functional Independence Measure (FIM) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• The Visual Analog Scale (VAS) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• 10 m Walk Test [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 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. PMID 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. PMID 23035004

Идентификаторы

NCT: NCT07286435 · 2025-16/7 and 09.09.2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗