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.
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
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
Parallel
Whole body vibration therapy
DeviceThe 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
DeviceThe 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.
Change from baseline in the maximum amplitude of the H-reflex, the Hmax/Mmax ratio, and F-wave parameters evaluated with EMNG.
-ENMG evaluation: Initially (0), 2 weeks after BoNT-A injection (Week 2), at the end of WBV treatment (Week 6), and at Week 12, an experienced neurologist will perform EMG to assess ankle spasticity. The maximum amplitude of the H-reflex, the Hmax/Mmax ratio, and F-wave parameters will be measured and recorded
Change from Baseline in the static balance and postural stability assessment
Initially (0), 2 weeks after BoNT-A injection (Week 2), at the end of WBV treatment (Week 6), and at Week 12, to assess static balance, participants will be evaluated for anteroposterior and mediolateral sway on both hard and foam surfaces with eyes open and closed using the HUR Smartbalance BTG4 balance platform (HUR-labs Oy, Kokkola, Finland). Additionally, limits of stability (LOS) measurements will be taken, and the results will be recorded.
MAS (Modified Ashworth Scale)
MAS is a muscle tone assessment scale used to evaluate resistance during passive range of motion, requiring no instrumentation, and can be performed quickly. The scale is graded as follows: 0: No increase in muscle tone 1: Slight increase in muscle tone with catching and release or minimal resistance at the end of the range of motion when the affected part(s) are moved in flexion or extension 1+: Slight increase in muscle tone, manifesting as catching, followed by minimal resistance (less than half) for the remainder of the range of motion. 2: There is a marked increase in muscle tone throughout most of the range of motion, but the affected part(s) can still be moved easily. 3: Significant increase in muscle tone, difficulty with passive movement. 4: Affected part(s) fixed in flexion or extension
TUGT (Timed Up and Go Test)
This Test assesses mobility; a chair and a stopwatch are required. The Test is conducted with the participant wearing their regular shoes, and they are allowed to use walking aids if necessary. A 3-meter area is designated in front of the chair. The participant is asked to stand up from the chair, walk a certain distance, and then sit down again. Time will tell the results of the Test.
The Functional Independence Measure (FIM)
The Functional Independence Measure (FIM): indicates an individual's level of independence in daily life activities. It consists of 18 items, including sections on self-care, sphincter control, transfer, mobility, communication, social perception, and cognitive status, with a scoring range of 18-126. It consists of motor (13 items) and cognitive (5 items) subscales. All items will be answered using a 7-point Likert scale. A validity and reliability study in Turkish has been conducted.
The Visual Analog Scale (VAS)
The Visual Analog Scale (VAS): is scored between 0 and 10. 0 represents the absence of spasticity during ambulation, and 10 represents the maximum intensity of spasticity that prevents ambulation.
10 m Walk Test
10 m Walk Test: During the Test, the participant walks at a normal walking speed between two markers 10 meters apart, and the time taken is recorded.
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