Effects of Different Pressure Garments on Upper Extremity Sensorimotor Functions and Quality of Life After Stroke

November 24, 2024 updated by: National University of Malaysia

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Weifang, Shandong, China, 261000
        • Recruiting
        • The Affiliated Hospital of Shandong Second Medical University
        • Contact:
      • Weifang, Shandong, China, 261000
        • Recruiting
        • Weifang Hospital of Traditional Chinese Medicine
        • Contact:
      • Weifang, Shandong, China, 261000
        • Recruiting
        • Weifang Municipal Peoples Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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), 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.
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.
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), 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.
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
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), 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment (FMA)
Time Frame: Baseline, Week 4. Week 8
A classic tool used to assess the rehabilitation process of stroke patients from the aspects of sensorimotor function and level of life activities. It has two main domains, i.e., upper extremity and lower extremity. The 33-item upper extremity domain that will be used in this study includes the range of motion of the shoulder, elbow, wrist, and fingers as well as elements such as grip strength and hand coordination. Scored between 0 and 66, higher scores indicating greater function.
Baseline, Week 4. Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale (MAS)
Time Frame: Baseline, Week 4. Week 8
A method used to assess muscle tone or muscle spasticity. It uses a scale of 0 to 4, where 0 indicates no spasticity and 4 indicates severe spasticity.
Baseline, Week 4. Week 8
Visual Analogue Scale (VAS)
Time Frame: Baseline, Week 4. Week 8
A 10-cm pain scale with one end of the scale represents no pain and the other end represents unbearable pain. Subjective perception of pain is obtained by drawing a vertical line between these two endpoints.
Baseline, Week 4. Week 8
Box and Block Test (BBT)
Time Frame: Baseline, Week 4. Week 8
A quantitative tool used to assess upper extremity sensorimotor function, including hand coordination, dexterity, speed of movement, and fine hand movements. Assessment is done by transferring a set of cubes from one side of a box separated into two equal-sized compartments (by a divider) to the other side within one minute.
Baseline, Week 4. Week 8
Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure
Time Frame: Baseline, Week 4. Week 8
A widely used tool for assessing upper extremity function. Its disability/symptom module has 30 items that covers a wide range of functional daily activities. Scored between 0 and 100, higher scores indicating more severe disability.
Baseline, Week 4. Week 8
36-Item Short Form Health Survey (SF-36)
Time Frame: Baseline, Week 4. Week 8
A 36-item survey questionnaire designed to provide insight into health status and quality of life of an individual, allowing comprehensive assessment of physical, psychological, and social functioning. Each dimension is converted into a score of 100 points by assigning weights to the entries according to the degree to which they affect the quality of life. The level of the score directly reflects the health status, with higher scores indicating better functional status and quality of life in this area.
Baseline, Week 4. Week 8

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brunnstrom Recovery Stage (BRS)
Time Frame: Prior to participant enrolment
A brief and easy-to-administer measure used to assess motor function. It consists of three items for the arm (BRS-A), hand (BRS-H), and leg (BRS-L), all of which are scored on a 6-point Likert-type scale, with each stage representing a different motor characteristic and change in muscle control.
Prior to participant enrolment
Modified Ashworth Score (MAS)
Time Frame: Prior to participant enrolment
A method used to assess muscle tone or muscle spasticity. It uses a scale of 0 to 4, where 0 indicates no spasticity and 4 indicates severe spasticity..
Prior to participant enrolment
Saint Louis University Mental Status (SLUMS) Examination
Time Frame: Prior to participant enrolment
A measure used to assess cognitive functioning. It assesses several cognitive domains such as attention, memory, executive functioning, orientation, and numeracy. Specific items include vocabulary learning, memory recall, numeracy, clock drawing, number reversal, and image naming. It is scored on a 30-point scale, with higher scores indicating better cognitive functioning and lower scores suggesting impaired cognitive functioning. Items are designed to cover multiple cognitive domains to provide a more comprehensive assessment.
Prior to participant enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Collaborators

Weifang Hospital of Traditional Chinese Medicine
The Affiliated Hospital of Shandong Second Medical University
Weifang Municipal People's Hospital

Investigators

  • Principal Investigator: SIaw Chui Chai, PhD, Occupational Therapy Programme, Centre for Rehabilitation and Special Needs Studies (iCaRehab)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

September 4, 2024

First Submitted That Met QC Criteria

September 5, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 24, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JEP-2024-582

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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