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

NCT05141695 | Completed

• 1 other identifier: 16-681-21
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Spasticity; Magnetic stimulation; Ultrasound; Magnetotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Fugl - Meyer Upper Extremity Motor Rating Scale

  Change from baseline at 4 weeks

• Modified Tardieu Scale

  Change from baseline at 4 weeks

• Ultrasound elastography

  Change from baseline at 4 weeks

Study Arms (2)

therapeutic group

EXPERIMENTAL

therapeutic repetitive peripheral magnetic stimulation

Device: therapeutic repetitive peripheral magnetic stimulation

sham group

SHAM COMPARATOR

sham repetitive peripheral magnetic stimulation

Device: sham repetitive peripheral magnetic stimulation

Interventions

therapeutic repetitive peripheral magnetic stimulation DEVICE

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.

therapeutic group

sham repetitive peripheral magnetic stimulation DEVICE

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.

sham group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine, Cebeci Hospital, Neurorehabilitation Clinic

Ankara, 06340, Turkey (Türkiye)

Location

Related Publications (8)

• Feigin VL, Roth GA, Naghavi M, Parmar P, Krishnamurthi R, Chugh S, Mensah GA, Norrving B, Shiue I, Ng M, Estep K, Cercy K, Murray CJL, Forouzanfar MH; Global Burden of Diseases, Injuries and Risk Factors Study 2013 and Stroke Experts Writing Group. Global burden of stroke and risk factors in 188 countries, during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet Neurol. 2016 Aug;15(9):913-924. doi: 10.1016/S1474-4422(16)30073-4. Epub 2016 Jun 9.

  PMID: 27291521 BACKGROUND

• Thibaut A, Chatelle C, Ziegler E, Bruno MA, Laureys S, Gosseries O. Spasticity after stroke: physiology, assessment and treatment. Brain Inj. 2013;27(10):1093-105. doi: 10.3109/02699052.2013.804202. Epub 2013 Jul 25.

  PMID: 23885710 BACKGROUND

• Lance JW. The control of muscle tone, reflexes, and movement: Robert Wartenberg Lecture. Neurology. 1980 Dec;30(12):1303-13. doi: 10.1212/wnl.30.12.1303. No abstract available.

  PMID: 7192811 BACKGROUND

• Lieber RL, Roberts TJ, Blemker SS, Lee SSM, Herzog W. Skeletal muscle mechanics, energetics and plasticity. J Neuroeng Rehabil. 2017 Oct 23;14(1):108. doi: 10.1186/s12984-017-0318-y.

  PMID: 29058612 BACKGROUND

• Bandholm T, Magnusson P, Jensen BR, Sonne-Holm S. Dorsiflexor muscle-group thickness in children with cerebral palsy: relation to cross-sectional area. NeuroRehabilitation. 2009;24(4):299-306. doi: 10.3233/NRE-2009-0482.

  PMID: 19597266 BACKGROUND

• Ozturk A, Grajo JR, Dhyani M, Anthony BW, Samir AE. Principles of ultrasound elastography. Abdom Radiol (NY). 2018 Apr;43(4):773-785. doi: 10.1007/s00261-018-1475-6.

  PMID: 29487968 BACKGROUND

• Vola EA, Albano M, Di Luise C, Servodidio V, Sansone M, Russo S, Corrado B, Servodio Iammarrone C, Caprio MG, Vallone G. Use of ultrasound shear wave to measure muscle stiffness in children with cerebral palsy. J Ultrasound. 2018 Sep;21(3):241-247. doi: 10.1007/s40477-018-0313-6. Epub 2018 Jul 20.

  PMID: 30030747 BACKGROUND

• Krewer C, Hartl S, Muller F, Koenig E. Effects of repetitive peripheral magnetic stimulation on upper-limb spasticity and impairment in patients with spastic hemiparesis: a randomized, double-blind, sham-controlled study. Arch Phys Med Rehabil. 2014 Jun;95(6):1039-47. doi: 10.1016/j.apmr.2014.02.003. Epub 2014 Feb 19.

  PMID: 24561057 BACKGROUND

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Haydar Gok, Professor

  Ankara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 2, 2021
• Study Start: April 1, 2022
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

TU (1)