This Study is About the Efficacy of Repetitive Peripheral Magnetic Stimulation on the Treatment of Shoulder Subluxation in Subacute Stroke Patients.

NCT ID: NCT06678425

Last Updated: 2024-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-12-31

Brief Summary

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The goal of this clinical trial is to study the efficacy of repetitive peripheral magnetic stimulation (rPMS) on shoulder subluxation in subacute stroke patients. The main questions it aims to answer are Could rPMS reduce shoulder subluxation and improve upper-limb motor recovery in subacute stroke patients?

Researchers will compare real rPMS to sham rPMS to see if rPMS works to improve shoulder subluxation and upper-limb motor recovery in subacute stroke patients.

Participants will:

* Get real rPMS or sham rPMS for 20 minutes, 5 days a week for 2 weeks
* Get conventional rehabilitation program 5 days a week for 2 weeks
* Follow-up at 2-, 4-, 8- and 12-weeks after first day of treatment

Detailed Description

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Conditions

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Shoulder Subluxation Subacute Stroke Magnetic Stimulation Randomised Controlled Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial, Double-blind, Sham-controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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real rPMS

Real rPMS was applied to supraspinatus and posterior deltoid muscles for 20 Hz total 2,400 pulses.

Group Type EXPERIMENTAL

Peripheral magnetic stimulator

Intervention Type DEVICE

a non-invasive method of delivering a rapidly pulsed, high-intensity magnetic field to peripheral muscles

sham rPMS

sham rPMS was applied to supraspinatus and posterior deltoid muscles with the same coil as real rPMS, but in a position perpendicular to the skin, using intensity for 5% of the maximum output.

Group Type SHAM_COMPARATOR

Peripheral magnetic stimulator

Intervention Type DEVICE

The same coil as real rPMS, but in a position perpendicular to the skin

Interventions

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Peripheral magnetic stimulator

a non-invasive method of delivering a rapidly pulsed, high-intensity magnetic field to peripheral muscles

Intervention Type DEVICE

Peripheral magnetic stimulator

The same coil as real rPMS, but in a position perpendicular to the skin

Intervention Type DEVICE

Other Intervention Names

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PMS PMS

Eligibility Criteria

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Inclusion Criteria

* Subacute phase (seven days to six months) and first time of stroke patients
* Shoulder subluxation that measured half of a fingerbreadth or more
* Meet the criteria for admission to a comprehensive rehabilitation program
* Medically stable
* Intact skin on the hemiparetic arm

Exclusion Criteria

* Patients with contraindication for magnetic stimulation; cardiac pacemakers, magnetic materials near the intended stimulation site
* Patients with pregnancy
* Patients with severe aphasia or severe cognitive impairment
* Patients with previous shoulder pathology or limit shoulder function before stroke
* Patients with unstable vital signs
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Medicine Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, Thailand

Site Status

Countries

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Thailand

Central Contacts

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Peerada Eurcherdkul, Doctor of Medicine

Role: CONTACT

+66922720652

Sivaporn Vongpipatana, Doctor of Medicine

Role: CONTACT

+66815756759

Facility Contacts

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Peerada Eurcherdkul, Doctor of Medicine

Role: primary

+66922720652

References

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Hemrungrojn S, Tangwongchai S, Charoenboon T, Panasawat M, Supasitthumrong T, Chaipresertsud P, Maleevach P, Likitjaroen Y, Phanthumchinda K, Maes M. Use of the Montreal Cognitive Assessment Thai Version to Discriminate Amnestic Mild Cognitive Impairment from Alzheimer's Disease and Healthy Controls: Machine Learning Results. Dement Geriatr Cogn Disord. 2021;50(2):183-194. doi: 10.1159/000517822. Epub 2021 Jul 29.

Reference Type RESULT
PMID: 34325427 (View on PubMed)

Manigandan JB, Ganesh GS, Pattnaik M, Mohanty P. Effect of electrical stimulation to long head of biceps in reducing gleno humeral subluxation after stroke. NeuroRehabilitation. 2014;34(2):245-52. doi: 10.3233/NRE-131041.

Reference Type RESULT
PMID: 24419017 (View on PubMed)

Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

Reference Type RESULT
PMID: 3809245 (View on PubMed)

Gladstone DJ, Danells CJ, Black SE. The fugl-meyer assessment of motor recovery after stroke: a critical review of its measurement properties. Neurorehabil Neural Repair. 2002 Sep;16(3):232-40. doi: 10.1177/154596802401105171.

Reference Type RESULT
PMID: 12234086 (View on PubMed)

Jiang YF, Zhang D, Zhang J, Hai H, Zhao YY, Ma YW. A Randomized Controlled Trial of Repetitive Peripheral Magnetic Stimulation applied in Early Subacute Stroke: Effects on Severe Upper-limb Impairment. Clin Rehabil. 2022 May;36(5):693-702. doi: 10.1177/02692155211072189. Epub 2022 Jan 5.

Reference Type RESULT
PMID: 34985366 (View on PubMed)

Hall J, Dudgeon B, Guthrie M. Validity of clinical measures of shoulder subluxation in adults with poststroke hemiplegia. Am J Occup Ther. 1995 Jun;49(6):526-33. doi: 10.5014/ajot.49.6.526.

Reference Type RESULT
PMID: 7645665 (View on PubMed)

Yang C, Chen P, Du W, Chen Q, Yang H, Su M. Musculoskeletal Ultrasonography Assessment of Functional Magnetic Stimulation on the Effect of Glenohumeral Subluxation in Acute Poststroke Hemiplegic Patients. Biomed Res Int. 2018 Jul 3;2018:6085961. doi: 10.1155/2018/6085961. eCollection 2018.

Reference Type RESULT
PMID: 30065941 (View on PubMed)

Fujimura K, Kagaya H, Endou C, Ishihara A, Nishigaya K, Muroguchi K, Tanikawa H, Yamada M, Kanada Y, Saitoh E. Effects of Repetitive Peripheral Magnetic Stimulation on Shoulder Subluxations Caused by Stroke: A Preliminary Study. Neuromodulation. 2020 Aug;23(6):847-851. doi: 10.1111/ner.13064. Epub 2019 Nov 5.

Reference Type RESULT
PMID: 32840021 (View on PubMed)

Beaulieu LD, Schneider C. Effects of repetitive peripheral magnetic stimulation on normal or impaired motor control. A review. Neurophysiol Clin. 2013 Oct;43(4):251-60. doi: 10.1016/j.neucli.2013.05.003. Epub 2013 Jun 10.

Reference Type RESULT
PMID: 24094911 (View on PubMed)

Linn SL, Granat MH, Lees KR. Prevention of shoulder subluxation after stroke with electrical stimulation. Stroke. 1999 May;30(5):963-8. doi: 10.1161/01.str.30.5.963.

Reference Type RESULT
PMID: 10229728 (View on PubMed)

Stecker MM, Patterson T, Netherton BL. Mechanisms of electrode induced injury. Part 1: theory. Am J Electroneurodiagnostic Technol. 2006 Dec;46(4):315-42.

Reference Type RESULT
PMID: 17285816 (View on PubMed)

Lee JH, Baker LL, Johnson RE, Tilson JK. Effectiveness of neuromuscular electrical stimulation for management of shoulder subluxation post-stroke: a systematic review with meta-analysis. Clin Rehabil. 2017 Nov;31(11):1431-1444. doi: 10.1177/0269215517700696. Epub 2017 Mar 27.

Reference Type RESULT
PMID: 28343442 (View on PubMed)

Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.

Reference Type RESULT
PMID: 27145936 (View on PubMed)

Arya KN, Pandian S, Puri V. Rehabilitation methods for reducing shoulder subluxation in post-stroke hemiparesis: a systematic review. Top Stroke Rehabil. 2018 Jan;25(1):68-81. doi: 10.1080/10749357.2017.1383712. Epub 2017 Oct 11.

Reference Type RESULT
PMID: 29017429 (View on PubMed)

Adey-Wakeling Z, Liu E, Crotty M, Leyden J, Kleinig T, Anderson CS, Newbury J. Hemiplegic Shoulder Pain Reduces Quality of Life After Acute Stroke: A Prospective Population-Based Study. Am J Phys Med Rehabil. 2016 Oct;95(10):758-63. doi: 10.1097/PHM.0000000000000496.

Reference Type RESULT
PMID: 27003204 (View on PubMed)

Kumar P, Fernando C, Mendoza D, Shah R. Risk and associated factors for hemiplegic shoulder pain in people with stroke: a systematic literature review. Physical Therapy Reviews. 2021;27(3):191-204.

Reference Type RESULT

Paci M, Nannetti L, Taiti P, Baccini M, Rinaldi L. Shoulder subluxation after stroke: relationships with pain and motor recovery. Physiother Res Int. 2007 Jun;12(2):95-104. doi: 10.1002/pri.349.

Reference Type RESULT
PMID: 17536647 (View on PubMed)

Stolzenberg D, Siu G, Cruz E. Current and future interventions for glenohumeral subluxation in hemiplegia secondary to stroke. Top Stroke Rehabil. 2012 Sep-Oct;19(5):444-56. doi: 10.1310/tsr1905-444.

Reference Type RESULT
PMID: 22982832 (View on PubMed)

Suethanapornkul S, Kuptniratsaikul PS, Kuptniratsaikul V, Uthensut P, Dajpratha P, Wongwisethkarn J. Post stroke shoulder subluxation and shoulder pain: a cohort multicenter study. J Med Assoc Thai. 2008 Dec;91(12):1885-92.

Reference Type RESULT
PMID: 19133525 (View on PubMed)

Turner-Stokes L, Jackson D. Shoulder pain after stroke: a review of the evidence base to inform the development of an integrated care pathway. Clin Rehabil. 2002 May;16(3):276-98. doi: 10.1191/0269215502cr491oa.

Reference Type RESULT
PMID: 12017515 (View on PubMed)

Paci M, Nannetti L, Rinaldi LA. Glenohumeral subluxation in hemiplegia: An overview. J Rehabil Res Dev. 2005 Jul-Aug;42(4):557-68. doi: 10.1682/jrrd.2004.08.0112.

Reference Type RESULT
PMID: 16320150 (View on PubMed)

Other Identifiers

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Ramathibodi Hospital

Identifier Type: OTHER

Identifier Source: secondary_id

MURA2024/673

Identifier Type: -

Identifier Source: org_study_id

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