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

NCT06587308 | Recruiting

• 1 other identifier: JEP-2024-582
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 3

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).

Conditions

Cerebral Vascular Accident (CVA)/Stroke

Keywords

Pressure Garment; Quality of Life; Stroke Rehabilitation; Occupational Therapy; Motor Activity; Sensory Feedback; Upper Extremity Paresis

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment (FMA)

  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 Outcomes (5)

• Modified Ashworth Scale (MAS)

  Baseline, Week 4. Week 8

• Visual Analogue Scale (VAS)

  Baseline, Week 4. Week 8

• Box and Block Test (BBT)

  Baseline, Week 4. Week 8

• Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure

  Baseline, Week 4. Week 8

• 36-Item Short Form Health Survey (SF-36)

  Baseline, Week 4. Week 8

Other Outcomes (3)

• Brunnstrom Recovery Stage (BRS)

  Prior to participant enrolment

• Modified Ashworth Score (MAS)

  Prior to participant enrolment

• Saint Louis University Mental Status (SLUMS) Examination

  Prior to participant enrolment

Study Arms (3)

Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment

EXPERIMENTAL

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

Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment

ACTIVE COMPARATOR

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

Single-Layered No Circumferential Reduction (S-0) Pressure Garment

PLACEBO COMPARATOR

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

Interventions

Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment OTHER

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.

Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment

Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment OTHER

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 10% Circumferential Reduction (S-10) Pressure Garment

Single-Layered No Circumferential Reduction (S-0) Pressure Garment OTHER

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.

Single-Layered No Circumferential Reduction (S-0) Pressure Garment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National University of Malaysia: lead
• The Affiliated Hospital of Shandong Second Medical University: collaborator
• Weifang Municipal People's Hospital: collaborator
• Weifang Hospital of Traditional Chinese Medicine: collaborator

Study Sites (3)

The Affiliated Hospital of Shandong Second Medical University

Weifang, Shandong, 261000, China

RECRUITING

Weifang Hospital of Traditional Chinese Medicine

Weifang, Shandong, 261000, China

RECRUITING

Weifang Municipal Peoples Hospital

Weifang, Shandong, 261000, China

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity; Paresis

Interventions

S 10

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• SIaw Chui Chai, PhD

  Occupational Therapy Programme, Centre for Rehabilitation and Special Needs Studies (iCaRehab)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenkun Xu, MSc

CONTACT

0129838798; P126687@siswa.ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)