The Effect of Whole-Body Vibration Therapy Following Botulinum Toxin A Injection on Spasticity and Balance in Stroke Patients
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Uludag University
- Enrollment
- 50
- Primary Endpoint
- Change from baseline in the maximum amplitude of the H-reflex, the Hmax/Mmax ratio, and F-wave parameters evaluated with EMNG.
Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
The research assistant will conduct all outcome measurement assessments, and the researcher will be blinded to the type of program being administered.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Change from baseline in the maximum amplitude of the H-reflex, the Hmax/Mmax ratio, and F-wave parameters evaluated with EMNG.
Time Frame: "From enrollment to the end of treatment at 12 weeks"
-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
Time Frame: From enrollment to the end of treatment at 12 weeks
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)
Time Frame: From enrollment to the end of treatment at 12 weeks
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)
Time Frame: From enrollment to the end of treatment at 8 weeks
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.
Berg Balance Scale (BBS)
Time Frame: From enrollment to the end of treatment at 12 weeks
It is used to assess functional balance and determine fall risk. The Test consists of 14 items. Values between 0 and 4 are given for each item. While 0 represents the worst value, 4 represents the best value. Four points indicate the ability to complete the task independently. The highest score is 56. Scores between 0-20 indicate balance impairment, scores between 21-40 indicate acceptable balance, and scores between 41-56 indicate good balance.
Secondary Outcomes
- The Functional Independence Measure (FIM)(From enrollment to the end of treatment at 12 weeks)
- The Visual Analog Scale (VAS)(From enrollment to the end of treatment at 12 weeks)
- 10 m Walk Test(From enrollment to the end of treatment at 12 weeks)
Investigators
Sevda Demir Türe
Specialist in Physical Medicine and Rehabilitation
Uludag University