Effects of Different Pressure Garments on Upper Extremity Sensorimotor Functions and Quality of Life After Stroke
NCT06587308 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165
Last updated 2024-11-27
Summary
The study aims to compare the effects of dorsal-double-layered 10% circumferential reduction (DD-10), single-layered 10% circumferential reduction (S-10), and single-layered no circumferential reduction (S-0) pressure garments on sensorimotor functions, including motor control, dexterity, muscle tone, pain, self-perceived upper extremity function, and quality of life among stroke patients during the 8 weeks of application (Time 1: Baseline, Time 2: Week 4, Time 3: Week 8).
Conditions
- Cerebral Vascular Accident (CVA)/Stroke
Interventions
- OTHER
-
Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment
During Phase IA, i.e., the first four weeks between Time 1 (Baseline) and Time 2 (Week 4), when participants are hospitalized in the rehabilitation department of the hospital. participants will need to wear the DD-10 pressure garment for 3 hours in the morning, 3 hours in the afternoon, and 8 hours at night daily. Additionally, all participants will need to attend an occupational therapy session for 30 minutes, 5 days a week. During Phase IB, i.e., the second four weeks between Time 2 (Week 4), and Time 3 (Week 8), when participants were being discharged from the hospital, they need to continually wearing the pressure garment according to same wearing schedule; however, the participants will not need to attend the occupational therapy session.
- OTHER
-
Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment
During Phase IA, i.e., the first four weeks between Time 1 (Baseline) and Time 2 (Week 4), when participants are hospitalized in the rehabilitation department of the hospital. participants will need to wear the S-10 pressure garment for 3 hours in the morning, 3 hours in the afternoon, and 8 hours at night daily. Additionally, all participants will need to attend an occupational therapy session for 30 minutes, 5 days a week. During Phase IB, i.e., the second four weeks between Time 2 (Week 4), and Time 3 (Week 8), when participants were being discharged from the hospital, they need to continually wearing the pressure garment according to same wearing schedule; however, the participants will not need to attend the occupational therapy session.
- OTHER
-
Single-Layered No Circumferential Reduction (S-0) Pressure Garment
During Phase IA, i.e., the first four weeks between Time 1 (Baseline) and Time 2 (Week 4), when participants are hospitalized in the rehabilitation department of the hospital. participants will need to wear the S-0 pressure garment for 3 hours in the morning, 3 hours in the afternoon, and 8 hours at night daily. Additionally, all participants will need to attend an occupational therapy session for 30 minutes, 5 days a week. During Phase IB, i.e., the second four weeks between Time 2 (Week 4), and Time 3 (Week 8), when participants were being discharged from the hospital, they need to continually wearing the pressure garment according to same wearing schedule; however, the participants will not need to attend the occupational therapy session.
Sponsors & Collaborators
-
The Affiliated Hospital of Shandong Second Medical University
collaborator UNKNOWN -
Weifang Municipal People's Hospital
collaborator UNKNOWN -
Weifang Hospital of Traditional Chinese Medicine
collaborator UNKNOWN -
National University of Malaysia
lead OTHER
Principal Investigators
-
SIaw Chui Chai, PhD · Occupational Therapy Programme, Centre for Rehabilitation and Special Needs Studies (iCaRehab)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-08
- Primary Completion
- 2026-08-31
- Completion
- 2026-08-31
Countries
- China
Study Locations
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