Clinical trial NCT06678425: This Study is About the Efficacy of Repetitive Peripheral Magnetic Stimulation on the Treatment of Shoulder Subluxation in Subacute Stroke Patients.
Official title: Efficacy of Repetitive Peripheral Magnetic Stimulation on Shoulder Subluxation in Subacute Stroke Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Shoulder Subluxation
Subacute Stroke
Magnetic Stimulation
Randomised Controlled Trial
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial, Double-blind, Sham-controlled trial
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Acromiohumeral interval
timeFrame: pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment
Secondary outcomes:
measure: Fugl-Meyer assessment of upper extremities (FMA-UE)
timeFrame: pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment
measure: Modified Ashworth Scale (MAS)
timeFrame: pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment
measure: Numeric Pain Rating Scale (NRS)
timeFrame: pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University
state: Bangkok
Study officials:
References:
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