Magnetic Stimulation, Randomised Controlled Trial, Shoulder Subluxation, Subacute Stroke
Conditions
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
Interventions
DEVICEPeripheral magnetic stimulator
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.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized controlled trial, Double-blind, Sham-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Thailand
Outcome results
None listed