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| ID | Type | Description | Link |
|---|---|---|---|
| Ramathibodi Hospital | Other Identifier | Ramathibodi Hospital |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| real rPMS | Experimental | Active rPMS administered for 10 sessions over a 2-week period (5 sessions per week) |
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| sham rPMS | Sham Comparator | Sham rPMS administered for 10 sessions over a 2-week period (5 sessions per week). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral magnetic stimulator | Device | Repetitive Peripheral Magnetic Stimulation (rPMS) applied to the supraspinatus and posterior deltoid muscles. Parameters include a frequency of 20 Hz, with a total of 2,400 pulses per session. |
| Measure | Description | Time Frame |
|---|---|---|
| Acromiohumeral interval | the shortest distance between two parallel lines drawn from the inferior border of the acromion and the superior border of the humerus head on the anteroposterior shoulder x-ray | pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer assessment of upper extremities (FMA-UE) | a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. Maximum score for upper extremity is 66 points. | pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Ramathibodi Hospital, Mahidol University | Ratchathewi | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34325427 | Result | 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. | |
| 24419017 |
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Randomized controlled trial, Double-blind, Sham-controlled trial
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| Peripheral magnetic stimulator | Device | Repetitive Peripheral Magnetic Stimulation (rPMS) applied to the supraspinatus and posterior deltoid muscles. The stimulation coil is placed in a perpendicular position to the skin surface, utilizing a stimulation intensity set at 5% of the maximum stimulator output. |
|
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| Modified Ashworth Scale (MAS) | a grade of spasticity from a 0-4 ordinal scale. The grade is assigned by moving a joint/muscle through a high velocity quick stretch. | pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment |
| Numeric Pain Rating Scale (NRS) | Measuring of pain intensity, respondents are asked to choose the single number that best represents their pain intensity, on a 0 (No Pain) to 10 (Worst pain) scale. | pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment |
| Result |
| 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. |
| 3809245 | Result | 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. |
| 12234086 | Result | 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. |
| 34985366 | Result | 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. |
| 7645665 | Result | 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. |
| 30065941 | Result | 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. |
| 32840021 | Result | 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. |
| 24094911 | Result | 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. |
| 10229728 | Result | 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. |
| 17285816 | Result | Stecker MM, Patterson T, Netherton BL. Mechanisms of electrode induced injury. Part 1: theory. Am J Electroneurodiagnostic Technol. 2006 Dec;46(4):315-42. |
| 28343442 | Result | 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. |
| 27145936 | Result | 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. |
| 29017429 | Result | 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. |
| 27003204 | Result | 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. |
| Result | 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. |
| 17536647 | 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. |
| 22982832 | Result | 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. |
| 19133525 | Result | 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. |
| 12017515 | Result | 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. |
| 16320150 | Result | 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. |