Shoulder SubluxationNCT06678425
This Study is About the Efficacy of Repetitive Peripheral Magnetic Stimulation on the Treatment of Shoulder Subluxation in Subacute Stroke Patients.
A study testing Peripheral magnetic stimulator in people with Shoulder Subluxation and Subacute Stroke, run by Mahidol University at 1 site in Thailand.
Trial summary
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?… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Subluxation, Subacute Stroke, Magnetic Stimulation
- What is being tested?
- Peripheral magnetic stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2025to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Ratchathewi, Bangkok, 10400
About this study
Official title: Efficacy of Repetitive Peripheral Magnetic Stimulation on Shoulder Subluxation in Subacute Stroke Patients
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
- Being tested
- Peripheral magnetic stimulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral magnetic stimulatorDevice
Also called PMS
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.
Peripheral magnetic stimulatorDevice
Also called PMS
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.
| Study group | Role | What they receive |
|---|---|---|
| real rPMS | Experimental | Active rPMS administered for 10 sessions over a 2-week period (5 sessions per week) Receives: Device: Peripheral magnetic stimulator |
| sham rPMS | Sham comparator | Sham rPMS administered for 10 sessions over a 2-week period (5 sessions per week). Receives: Device: Peripheral magnetic stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment
Secondary outcomes (3)
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.
Measured: pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment
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.
Measured: 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.
Measured: pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Jan 2025
- Primary completion1 Jan 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Shoulder SubluxationStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial, Double-blind, Sham-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678425
- Sponsor's protocol ID
- MURA2024/673
- Other IDs
- Ramathibodi Hospital
- Status last verified
- Mar 2026
- First submitted
- 6 Nov 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34325427Manigandan 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.
PubMed 24419017Bohannon 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.
PubMed 3809245Gladstone 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.
PubMed 12234086Jiang 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.
PubMed 34985366Hall 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.
PubMed 7645665Yang 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.
PubMed 30065941Fujimura 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.
PubMed 32840021Beaulieu 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.
PubMed 24094911Linn 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.
PubMed 10229728Stecker MM, Patterson T, Netherton BL. Mechanisms of electrode induced injury. Part 1: theory. Am J Electroneurodiagnostic Technol. 2006 Dec;46(4):315-42.
PubMed 17285816Lee 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.
PubMed 28343442Winstein 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.
PubMed 27145936Arya 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.
PubMed 29017429Adey-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.
PubMed 27003204
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Repetitive Peripheral Magnetic Stimulation on Shoulder Subluxation in Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT06678425
- Acronym / sponsor ID
- MURA2024/673
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial, Double-blind, Sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| real rPMS | Experimental | Device: Peripheral magnetic stimulatorActive rPMS administered for 10 sessions over a 2-week period (5 sessions per week) |
| sham rPMS | Sham comparator | Device: Peripheral magnetic stimulatorSham rPMS administered for 10 sessions over a 2-week period (5 sessions per week). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral magnetic stimulatorAlso: PMSRepetitive 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. | Device | real rPMS |
| Peripheral magnetic stimulatorAlso: PMSRepetitive 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. | Device | sham rPMS |
Primary outcome
Acromiohumeral interval
Time frame: pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment
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
3 secondary outcomes
Fugl-Meyer assessment of upper extremities (FMA-UE)
Time frame: pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment
Modified Ashworth Scale (MAS)
Time frame: pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment
Numeric Pain Rating Scale (NRS)
Time frame: pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Results publication: PubMed 34325427Hemrungrojn 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.
- Results publication: PubMed 24419017Manigandan 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.
- Results publication: PubMed 3809245Bohannon 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.
- Results publication: PubMed 12234086Gladstone 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.
- Results publication: PubMed 34985366Jiang 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.
- Results publication: PubMed 7645665Hall 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.
- Results publication: PubMed 30065941Yang 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.
- Results publication: PubMed 32840021Fujimura 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.
- Results publication: PubMed 24094911Beaulieu 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.
- Results publication: PubMed 10229728Linn 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.
- Results publication: PubMed 17285816Stecker MM, Patterson T, Netherton BL. Mechanisms of electrode induced injury. Part 1: theory. Am J Electroneurodiagnostic Technol. 2006 Dec;46(4):315-42.
- Results publication: PubMed 28343442Lee 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.
- Individual participant dataSharing planned: Undecided
Related trials for Shoulder Subluxation
Recruiting
Validation of an Upper Extremity Physical Performance Test Battery in Patients After Shoulder Dislocation
Return to Sport, Shoulder Dislocation or Subluxation
Not yet recruiting
Assessment of Posterior Subluxation of the Humeral Head Using Biplanar Imaging in the Upright Position in Patients Scheduled for Total Shoulder Arthroplasty
Shoulder Arthroplasty
Not yet recruitingObservational study
Investigation of the Relationship Between Shoulder Alpha Angle and Humeral Head Displacement Percentage Measured by Ultrasonography in Neonatal Brachial Plexus Palsy Infants With Clinical Parameters
Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy
Active, not recruiting
The Effect of Good Limb Position Management Assistive Devices on Preventing Shoulder Subluxation in Hemiplegic Patients
Hemiplegia and/or Hemiparesis Following Stroke
RecruitingObservational study
Clinical Outcomes of Arthroscopic Surgeries for Shoulder and Knee Sports Injuries
Athletic Injuries (C26.857.500.124), Rotator Cuff Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral magnetic stimulator in people with Shoulder Subluxation and Subacute Stroke, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acromiohumeral interval (time frame: pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06678425, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.