Comparing different pressure garments for improving upper limb function after stroke
Effects of Pressure Garments of Varying Designs on Upper Extremity Sensorimotor Functions and Quality of Life After Stroke: A Multicenter, Double-Blind, Prospective Randomized Controlled Trial
This study is testing which type of pressure garment can help stroke patients improve their arm function and quality of life over eight weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | National University of Malaysia Academic / other |
| Locations | 3 sites (Weifang, Shandong and 2 other locations) |
| Trial ID | NCT06587308 on ClinicalTrials.gov |
What this trial studies
This study compares the effects of three types of pressure garments on sensorimotor functions and quality of life in stroke patients over an 8-week period. Participants will be assigned to wear either a dorsal-double-layered garment with 10% circumferential reduction, a single-layered garment with 10% circumferential reduction, or a single-layered garment with no circumferential reduction. Assessments will be made at baseline, week 4, and week 8 to evaluate motor control, dexterity, muscle tone, pain, and self-perceived upper extremity function. The goal is to determine which garment provides the most benefit in rehabilitation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have experienced their first stroke within the last 1-12 months and have hemiparesis with specific motor function criteria.
Not a fit: Patients with serious cardiovascular or respiratory diseases, skin problems, or severe cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance rehabilitation strategies for stroke patients, improving their upper limb function and overall quality of life.
How similar studies have performed: While the specific approach of using different pressure garments is novel, similar studies in stroke rehabilitation have shown promising results with various therapeutic interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between 18 and 80 years of age * Within 1-12 months of ischemic or hemorrhagic stroke * First onset resulting in hemiparesis of a limb with Burnnstrom stage of 3, 4 or 5 * Modified Ashworth Scale with scores of less than or equal 2 for elbow, wrist, and hand muscle tone in the affected upper extremity * Able to understand instruction Exclusion Criteria: * Serious cardiovascular or respiratory diseases * Skin lesions, infections or other skin problems * Serious circulatory problems such as deep vein thrombosis * Allergies or significant discomfort to pressure garment materials * Upper extremity fractures or severe joint problems * Severe cognitive impairment with Saint Louis University Mental Status (SLUMs) scores equal to or less than 27 (above high school level of education)/25 (below high school level of education)
Where this trial is running
Weifang, Shandong and 2 other locations
- The Affiliated Hospital of Shandong Second Medical University — Weifang, Shandong, China (Recruiting)
- Weifang Hospital of Traditional Chinese Medicine — Weifang, Shandong, China (Recruiting)
- Weifang Municipal Peoples Hospital — Weifang, Shandong, China (Recruiting)
Study contacts
- Principal investigator: SIaw Chui Chai, PhD — Occupational Therapy Programme, Centre for Rehabilitation and Special Needs Studies (iCaRehab)
- Study coordinator: Zhenkun Xu, MSc
- Email: P126687@siswa.ukm.edu.my
- Phone: 0129838798
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.