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

Mahidol University

Status and phase: Not yet enrolling; Phase 3; Phase 2

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

Treatments: Device: Peripheral magnetic stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT06678425

Ramathibodi Hospital

MURA2024/673

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

real rPMS

Experimental group

Description:

Real rPMS was applied to supraspinatus and posterior deltoid muscles for 20 Hz total 2,400 pulses.

Treatment:

Device: Peripheral magnetic stimulator

Device: Peripheral magnetic stimulator

sham rPMS

Sham Comparator group

Description:

sham rPMS was applied to supraspinatus and posterior deltoid muscles with the same coil as real rPMS, but in a position perpendicular to the skin, using intensity for 5% of the maximum output.

Treatment:

Device: Peripheral magnetic stimulator

Device: Peripheral magnetic stimulator