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

NCT06678425 | Completed DMC

• 2 other identifiers: MURA2024/673Ramathibodi Hospital
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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? 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

Conditions

Shoulder Subluxation; Subacute Stroke; Magnetic Stimulation; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Fugl-Meyer assessment of upper extremities (FMA-UE)

  pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment

• Modified Ashworth Scale (MAS)

  pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment

• Numeric Pain Rating Scale (NRS)

  pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment

Study Arms (2)

real rPMS

EXPERIMENTAL

Active rPMS administered for 10 sessions over a 2-week period (5 sessions per week)

Device: Peripheral magnetic stimulator

sham rPMS

SHAM COMPARATOR

Sham rPMS administered for 10 sessions over a 2-week period (5 sessions per week).

Device: Peripheral magnetic stimulator

Interventions

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.

Also known as: PMS

real rPMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (21)

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  RESULT

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial, Double-blind, Sham-controlled trial

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 7, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 15, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

TH (1)