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Completed

NCT Number: NCT06678425

This Study is About the Efficacy of Repetitive Peripheral Magnetic Stimulation on the Treatment of 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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PMS

Primary outcomes

  1. 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

Secondary outcomes

  1. Fugl-Meyer assessment of upper extremities (FMA-UE)

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

    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.

  2. Modified Ashworth Scale (MAS)

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

    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.

  3. Numeric Pain Rating Scale (NRS)

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

    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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Efficacy of Repetitive Peripheral Magnetic Stimulation on Shoulder Subluxation in Subacute Stroke Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2024
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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