Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2025-12-27 @ 9:34 PM
Study NCT ID:
NCT05141695
Status:
COMPLETED
Last Update Posted:
2025-01-29
First Post:
2021-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Repetitive Peripheral Magnetic Stimulation on Upper Extremity Spasticity After Stroke
Sponsor:
Ankara University
Organization:
Study Overview
Official Title:
Evaluation of the Effect of Repetitive Peripheral Magnetic Stimulation With Shearwave Ultrasound Elastography in Upper Extremity Spasticity After Stroke: a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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%.
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%.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: