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
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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NOT_YET_RECRUITING
PHASE2/PHASE3
20 participants
INTERVENTIONAL
2025-01-01
2026-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
Peripheral magnetic stimulator
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.
Peripheral magnetic stimulator
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
Peripheral magnetic stimulator
The same coil as real rPMS, but in a position perpendicular to the skin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Locations
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Faculty of Medicine Ramathibodi Hospital, Mahidol University
Ratchathewi, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Stecker MM, Patterson T, Netherton BL. Mechanisms of electrode induced injury. Part 1: theory. Am J Electroneurodiagnostic Technol. 2006 Dec;46(4):315-42.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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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