Evaluation of the Effect of Repetitive Peripheral Magnetic Stimulation on Upper Extremity Spasticity After Stroke

Study Overview
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Brief Summary
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Spasticity is a frequent problem in post-stroke patients. It can negatively affect the functional recovery of patients and impair their quality of life. The repetitive pulsed magnetic stimulation (rPMS) treatment has been shown to cause a reduction in muscle tone and improvement in activities of daily living in stroke patients. So far, the effects of rPMS on muscle tone, which is the neurophysiological component of spasticity, have been evaluated, but its effects on the biomechanical component (soft tissue stiffness) have not been demonstrated. In this study, the effects of rPMS on soft tissue stiffness as well as increased muscle tone will be evaluated with clinical and ultrasound elastography in post-stroke patients with upper extremity spasticity.

Detailed Description
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The study is a randomized, double-blind, sham-controlled trial. Pos-stroke patients who applied to the Ankara University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation and developed upper extremity spasticity will be included in the study. Patients included in the study will be randomized into two groups; treatment group and sham group. The block randomization will be preferred using the Random Allocation Software (RAS). 10 sessions of stretching exercises will be applied to all patients once a day, five sessions a week, with each session lasting 20 minutes. Patients in the treatment group will receive an additional peripheral magnetic stimulation therapy for the upper extremity arm/forearm spastic muscles on the hemiplegic side for a total of 10 sessions once a day, five sessions a week, for two weeks, each session lasting ten minutes. The patient will be seated in a chair. rPMS will not be given to the sham group, the device will not be operated, the probe of the device will be positioned in the same way as the patients in the treatment group for ten minutes, and the sounds recorded during the operation of the device will be heard by the patients. The patients and evaluators will not know which group the patients are in. rPMS treatment will be applied with the BTL-6000 Super Inductive System Elite in compliance with the recommendation by the manufacturer. The rPMS treatment parameters will be adjusted to use stimulus intensity above the motor threshold which is determined individually for each patient. Duration of each session will be 10 minutes. Socio-demographic data such as gender, age, education level, occupation, background, duration of stroke, type of lesion, history of comorbidities and drugs used for spasticity including the botulinum toxin injection will be recorded. The patients will be evaluated three times; at the beginning, after the treatment (week 2) and two weeks after the end of the treatment. Patients will be evaluated with the Fugl - Meyer Upper Extremity Motor Rating Scale, Modified Ashworth Scale (MAS) and Modified Tardieu Scale. Measurement of tissue stiffness will be made by shear wave elastography technique on the spastic upper extremity forearm/wrist flexor muscles of the affected side. Measurements will be made with the Siemens ACUSON S2000 Ultrasound System in kilopascals (kPa). The Modified Ashworth Scale is considered the primary clinical measure of muscle spasticity. Hence it will be used as the primary outcome variable. Patients with severe spasticity (MAS stage 4) will not be included in the study. One unit decrease in MAS will be considered as clinically significant. Accordingly a power analysis yielded a sample size of 68 volunteers with 80% power and 5% margin of error. However, due to the nature of the study, it was planned to include a total of 76 volunteers, with an expected loss of 10%.

Official Title
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Evaluation of the Effect of Repetitive Peripheral Magnetic Stimulation With Shearwave Ultrasound Elastography in Upper Extremity Spasticity After Stroke: a Randomized Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Device: therapeutic repetitive peripheral magnetic stimulation
* Device: sham repetitive peripheral magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being diagnosed with stroke according to the definition of the World Health Organization (1989) Being over 18 years old Having a stroke confirmed by Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) Patients with spasticity between grade 1 and 3 according to the Modified Ashworth Scale (MAS) in the upper extremity arm/forearm muscle Wellness of the patient's general condition after stroke Exclusion Criteria: Patients treated with botulinum toxin, phenol, alcohol injection for spasticity in the last 6 months Patients who have previously undergone antispastic surgery to the treatment area Patients with a change in oral antispastic drug use in the last 6 months Patients with fixed contractures in the elbow and wrist Patients with signs of acute inflammation in the treatment area Patients with bleeding diathesis Patients with implanted devices (cardiac pacemaker, cochlear implant, drug pumps) Patients with vascular problems such as deep vein thrombosis, phlebitis, varicose veins, arterial disease Patients with a history of cancer in the treatment area Pregnancy Patients with metal implants in the treatment area Patients with nonunion fractures at the treatment site

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: therapeutic group<br>therapeutic repetitive peripheral magnetic stimulation | Device: therapeutic repetitive peripheral magnetic stimulation<br>* Patients in the treatment group will receive peripheral magnetic stimulation therapy for the upper extremity arm/forearm spastic muscles on the hemiplegic side for a total of ten sessions once a day, five sessions a week, for two weeks, each session lasting ten minutes. Ten sessions of stretching exercises will be applied to all patients once a day, five sessions a week, with each session lasting 20 minutes.<br>|
| Sham Comparator: sham group<br>sham repetitive peripheral magnetic stimulation | Device: sham repetitive peripheral magnetic stimulation<br>* rPMS will not be given to the sham group, the device will not be operated, the probe of the device will be positioned in the same way as the patients in the treatment group for ten minutes, and the sounds recorded during the operation of the device will be heard by the patients. Patients and evaluators will not know which group the patients are in. Ten sessions of stretching exercises will be applied to all patients once a day, five sessions a week, with each session lasting 20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth Scale | The Modified Ashworth scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Scores range from 0 to 4, where lower values represent normal muscle tone and higher values represent spasticity: 0: No increase in muscle tone; 1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved; 3: Considerable increase in muscle tone, passive movement difficult; 4: Affected part(s) rigid in flexion or extension | Change from baseline at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl - Meyer Upper Extremity Motor Rating Scale | The Fugl - Meyer Upper Extremity Motor Rating Scale is a measure of upper-extremity motor weakness after stroke. It consists of 30 items assessing motor function and 3 items assessing reflex function. The 33 items that constitute the scale are scored on an ordinal scale of 0 (absent), 1 (partial impairment), and 2 (no impairment), resulting in a range of possible scores from 0 to 66. Lower values represent severe motor impairment, higher values represent mild motor impairment. The difference between R2 and R1 will be the measure of the dynamic component of spasticity. | Change from baseline at 4 weeks | 
| Modified Tardieu Scale | The Modified Tardieu Scale is used clinically to measure spasticity in patients with neurological conditions. It is differentiated into 3 parts and measures the passive range of motion (described as R2) at a stretching velocity as slow as possible (described as VI); grades the quality of muscle reaction to passive stretch at the fastest stretching velocity (described as V3); and 3) measures the angle of muscle reaction at the point of resistance to the fastest stretching velocity when the overactive stretch reflex produces a first catch (angle of muscle reaction; described as R1). The quality of muscle reaction was then rated at the fastest stretching velocity, and scores range from 0 to 5; 0 is no resistance to passive ROM to 5 indicating joint is immobile. The difference between R2 and R1 will be the measure of the dynamic component of spasticity. | Change from baseline at 4 weeks | 
| Ultrasound elastography | A method to measure tissue stiffness quantitatively. | Change from baseline at 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Spasticity, Magnetic stimulation, Ultrasound, Magnetotherapy