Recruiting NCT06587308
Effects of Different Pressure Garments on Upper Extremity Sensorimotor Functions and Quality of Life After Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment, Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment, Single-Layered No Circumferential Reduction (S-0) Pressure Garment.
- Who it may be relevant to
- Registry conditions: Cerebral Vascular Accident (CVA)/Stroke. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
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), - 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), a - 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), an
Primary outcome measures
- Fugl-Meyer Assessment (FMA) [Time frame: Baseline, Week 4. Week 8]
Secondary outcome measures (5)
- Modified Ashworth Scale (MAS) [Time frame: Baseline, Week 4. Week 8]
- Visual Analogue Scale (VAS) [Time frame: Baseline, Week 4. Week 8]
- Box and Block Test (BBT) [Time frame: Baseline, Week 4. Week 8]
- Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure [Time frame: Baseline, Week 4. Week 8]
- 36-Item Short Form Health Survey (SF-36) [Time frame: Baseline, Week 4. 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 3 centers
- The Affiliated Hospital of Shandong Second Medical University — Weifang
- Weifang Hospital of Traditional Chinese Medicine — Weifang
- Weifang Municipal Peoples Hospital — Weifang
Publications
- Xu Z, Chai SC, Chu SY, Li K. 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. PLoS One. 2025 Jun 23;20(6):e0326680. doi: 10.1371/journal.pone.0326680. eCollection 2025. PMID 40549786
Identifiers
NCT: NCT06587308 · JEP-2024-582