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

Phase 2

Not yet recruiting

• Conditions: Shoulder Subluxation; Subacute Stroke; Magnetic Stimulation; Randomised Controlled Trial

• Registration Number: NCT06678425
• Lead Sponsor: Mahidol University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-06
• Last Update Submitted: 2024-11-06
• Study First Posted: 2024-11-07
• Last Update Posted: 2024-11-07
• Study Start: 2025-01-01
• Primary Completion: 2026-09-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acromiohumeral interval	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 Outcome Measures

Name	Time	Method
Fugl-Meyer assessment of upper extremities (FMA-UE)	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.
Numeric Pain Rating Scale (NRS)	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.
Modified Ashworth Scale (MAS)	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.

Trial Locations

Locations (1)

Faculty of Medicine Ramathibodi Hospital, Mahidol University; 🇹🇭 Ratchathewi, Bangkok, Thailand