Effects of Different Pressure Garments on Upper Extremity Sensorimotor Functions and Quality of Life After Stroke
NCT ID: NCT06587308
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
165 participants
INTERVENTIONAL
2024-10-08
2026-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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.
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 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.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Affiliated Hospital of Shandong Second Medical University
UNKNOWN
Weifang Municipal People's Hospital
UNKNOWN
Weifang Hospital of Traditional Chinese Medicine
UNKNOWN
National University of Malaysia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
SIaw Chui Chai, PhD
Role: PRINCIPAL_INVESTIGATOR
Occupational Therapy Programme, Centre for Rehabilitation and Special Needs Studies (iCaRehab)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JEP-2024-582
Identifier Type: -
Identifier Source: org_study_id