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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The Affiliated Hospital of Shandong Second Medical University
RECRUITING
Weifang
Weifang Hospital of Traditional Chinese Medicine
RECRUITING
Weifang
Weifang Municipal Peoples Hospital
RECRUITING
Weifang
Contact Information
Primary
Zhenkun Xu, MSc
P126687@siswa.ukm.edu.my
0129838798
Time Frame
Start Date: 2024-10-08
Estimated Completion Date: 2026-08
Participants
Target number of participants: 165
Treatments
Experimental: 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
Active_comparator: 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.
Placebo_comparator: 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
Related Therapeutic Areas
Sponsors
Collaborators: The Affiliated Hospital of Shandong Second Medical University, Weifang Hospital of Traditional Chinese Medicine, Weifang Municipal People's Hospital
Leads: National University of Malaysia

This content was sourced from clinicaltrials.gov

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