Clinical trial NCT06587308: Effects of Different Pressure Garments on Upper Extremity Sensorimotor Functions and Quality of Life After Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Vascular Accident (CVA)/Stroke
Keywords: Pressure Garment
Quality of Life
Stroke Rehabilitation
Occupational Therapy
Motor Activity
Sensory Feedback
Upper Extremity Paresis
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital of Shandong Second Medical University
name: Weifang Municipal People's Hospital
name: Weifang Hospital of Traditional Chinese Medicine
First posted: 2024-09-19
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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)

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: Baseline, Week 4. Week 8
Secondary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: Baseline, Week 4. Week 8
measure: Visual Analogue Scale (VAS)
timeFrame: Baseline, Week 4. Week 8
measure: Box and Block Test (BBT)
timeFrame: Baseline, Week 4. Week 8
measure: Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure
timeFrame: Baseline, Week 4. Week 8
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: Baseline, Week 4. Week 8
Other outcomes:
measure: Brunnstrom Recovery Stage (BRS)
timeFrame: Prior to participant enrolment
measure: Modified Ashworth Score (MAS)
timeFrame: Prior to participant enrolment
measure: Saint Louis University Mental Status (SLUMS) Examination
timeFrame: Prior to participant enrolment
Locations:
city: Weifang
country: China
facility: The Affiliated Hospital of Shandong Second Medical University
state: Shandong
city: Weifang
country: China
facility: Weifang Hospital of Traditional Chinese Medicine
state: Shandong
city: Weifang
country: China
facility: Weifang Municipal Peoples Hospital
state: Shandong
Study officials:
affiliation: Occupational Therapy Programme, Centre for Rehabilitation and Special Needs Studies (iCaRehab)
name: SIaw Chui Chai, PhD
role: PRINCIPAL_INVESTIGATOR
References: