In-bed self-exercise program for patients recovering from stroke
Protocol for a Single-blind Randomized Controlled Clinical Trial to Investigate the Feasibility and Safety of In-bed Self-exercise Based on Electromyography Sensor Feedback in Patients With Subacute Stroke
This study tests if an in-bed exercise program using sensors can help stroke patients recover better when combined with regular rehab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul, Jongno) |
| Trial ID | NCT05820815 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and safety of an in-bed self-exercise program utilizing EMG-sensor feedback for patients who have experienced a subacute stroke. Participants in the intervention group will engage in graded exercises tailored to their muscle strength and recovery stages, alongside conventional rehabilitation methods. The study aims to measure various outcomes, including participation rates and motor recovery assessments, to determine the effectiveness of this innovative approach compared to standard rehabilitation alone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older who have experienced a stroke within the last three months and have lower extremity weakness.
Not a fit: Patients with stroke recurrence, severe cognitive impairment, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance recovery outcomes for stroke patients by providing a tailored exercise regimen that promotes motor function improvement.
How similar studies have performed: While the approach of using EMG feedback for rehabilitation is promising, this specific application in subacute stroke patients is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 19 years and older * the onset of the stroke is less than 3months ago * Lower extremity weakness due to stroke (MMT =\< 4 grade) * Modified Rankine Scale 2-5 points * Cognitive ability to follow commands Exclusion Criteria: * stroke recurrence * other neurological abnormalities (e.g. parkinson's disease). * severely impaired cognition * serious and complex medical conditions(e.g. active cancer) * cardiac pacemaker or other implanted electronic system
Where this trial is running
Seoul, Jongno
- Seoul National University Hospital — Seoul, Jongno, South Korea (Recruiting)
Study contacts
- Principal investigator: Woo Hyung Lee, prof — Seoul National University Hospital
- Study coordinator: JungHyun Kim, prof
- Email: kiking0@naver.com
- Phone: 01088632341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.