Comparing Different Pressure Garments for Improving Arm Function and Quality of Life After Stroke in Adults
Led by National University of Malaysia · Updated on 2024-11-27
165
Participants Needed
3
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of three types of pressure garments on upper extremity sensorimotor functions and quality of life in stroke patients. The study compares a dorsal-double-layered 10% circumferential reduction garment DD-10, a single-layered 10% circumferential reduction garment S-10, and a single-layered garment with no circumferential reduction S-0. These treatments are assessed over 8 weeks at baseline, 4 weeks, and 8 weeks to measure motor control, dexterity, muscle tone, pain, self-perceived function, and quality of life.
Participants will wear custom-fabricated finger-to-above-elbow pressure garments according to their assigned group. During the first 4 weeks Phase IA, while hospitalized, they will wear the garment for 3 hours in the morning, 3 hours in the afternoon, and 8 hours at night daily, alongside 30-minute occupational therapy sessions five days per week. During the second 4 weeks Phase IB, after hospital discharge, participants will continue wearing the garment on the same schedule but will no longer attend occupational therapy sessions.
Throughout the study, participants will be assessed using various measures including the Fugl-Meyer Assessment, Modified Ashworth Scale, Visual Analogue Scale, Box and Block Test, Disabilities of Arm, Shoulder and Hand Outcome Measure, and the 36-Item Short Form Health Survey at baseline, week 4, and week 8. The study is conducted with randomized assignment and triple blinding to evaluate outcomes related to sensorimotor function and quality of life in stroke survivors over the 8-week period.
CONDITIONS
Brief Title
Effects of Different Pressure Garments on Upper Extremity Sensorimotor Functions and Quality of Life After Stroke
Research Team
Z
Zhenkun Xu, MSc
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The Affiliated Hospital of Shandong Second Medical University
Collaborating Sponsor
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
Between 18 and 80 years of age
Stroke occurred within the past 1 to 12 months (ischemic or hemorrhagic)
First stroke causing weakness (hemiparesis) in an arm or hand with Burnnstrom stage 3, 4, or 5
Muscle tone scores of 2 or less on the Modified Ashworth Scale for elbow, wrist, and hand
Able to understand and follow instructions
You will not qualify if you...
Serious heart or lung diseases
Skin problems such as lesions or infections
Serious blood circulation issues like deep vein thrombosis
Allergies or discomfort using pressure garment materials
Fractures or severe joint problems in the affected arm
Severe cognitive impairment with low scores on the Saint Louis University Mental Status exam
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants wear a pressure garment daily for 8 weeks and attend occupational therapy sessions during the first 4 weeks while hospitalized. The wearing schedule is 3 hours in the morning, 3 hours in the afternoon, and 8 hours at night. Occupational therapy sessions last 30 minutes, 5 days a week during the first 4 weeks only.
Baseline visit and visits at Week 4 and Week 8
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Effects of pressure garments of varying designs on upper extremity sensorimotor functions and quality of life after stroke: Study protocol for a multicenter, double-blind, prospective randomized controlled trial.