Effects of Different Pressure Garments on Upper Extremity Sensorimotor Functions and Quality of Life After Stroke
- Conditions
- Cerebral Vascular Accident (CVA)/Stroke
- Interventions
- Other: Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure GarmentOther: Single-Layered 10% Circumferential Reduction (S-10) Pressure GarmentOther: Single-Layered No Circumferential Reduction (S-0) Pressure Garment
- Registration Number
- NCT06587308
- Lead Sponsor
- National University of Malaysia
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 165
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment A custom-fabricated finger-to-above-elbow (long glove) pressure garment with 10% of stress. The design is similar to S-10 except it has an extra layer of fabric on the dorsal aspect that gives stronger compression Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment A custom-fabricated single-layered finger-to-above-elbow (long glove) pressure garment with 10% of stress. Single-Layered No Circumferential Reduction (S-0) Pressure Garment Single-Layered No Circumferential Reduction (S-0) Pressure Garment A custom-fabricated single-layered finger-to-above-elbow (long glove) pressure garment with 0% of stress
- Primary Outcome Measures
Name Time Method Fugl-Meyer Assessment (FMA) Baseline, Week 4. Week 8 A classic tool used to assess the rehabilitation process of stroke patients from the aspects of sensorimotor function and level of life activities. It has two main domains, i.e., upper extremity and lower extremity. The 33-item upper extremity domain that will be used in this study includes the range of motion of the shoulder, elbow, wrist, and fingers as well as elements such as grip strength and hand coordination. Scored between 0 and 66, higher scores indicating greater function.
- Secondary Outcome Measures
Name Time Method Modified Ashworth Scale (MAS) Baseline, Week 4. Week 8 A method used to assess muscle tone or muscle spasticity. It uses a scale of 0 to 4, where 0 indicates no spasticity and 4 indicates severe spasticity.
Visual Analogue Scale (VAS) Baseline, Week 4. Week 8 A 10-cm pain scale with one end of the scale represents no pain and the other end represents unbearable pain. Subjective perception of pain is obtained by drawing a vertical line between these two endpoints.
Box and Block Test (BBT) Baseline, Week 4. Week 8 A quantitative tool used to assess upper extremity sensorimotor function, including hand coordination, dexterity, speed of movement, and fine hand movements. Assessment is done by transferring a set of cubes from one side of a box separated into two equal-sized compartments (by a divider) to the other side within one minute.
Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure Baseline, Week 4. Week 8 A widely used tool for assessing upper extremity function. Its disability/symptom module has 30 items that covers a wide range of functional daily activities. Scored between 0 and 100, higher scores indicating more severe disability.
36-Item Short Form Health Survey (SF-36) Baseline, Week 4. Week 8 A 36-item survey questionnaire designed to provide insight into health status and quality of life of an individual, allowing comprehensive assessment of physical, psychological, and social functioning. Each dimension is converted into a score of 100 points by assigning weights to the entries according to the degree to which they affect the quality of life. The level of the score directly reflects the health status, with higher scores indicating better functional status and quality of life in this area.
Trial Locations
- Locations (3)
The Affiliated Hospital of Shandong Second Medical University
🇨🇳Weifang, Shandong, China
Weifang Hospital of Traditional Chinese Medicine
🇨🇳Weifang, Shandong, China
Weifang Municipal Peoples Hospital
🇨🇳Weifang, Shandong, China