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

NCT06587308 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2024-11-27

No results posted yet for this study

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

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), 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.

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.

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.

Sponsors & Collaborators

  • The Affiliated Hospital of Shandong Second Medical University

    collaborator UNKNOWN
  • Weifang Municipal People's Hospital

    collaborator UNKNOWN
  • Weifang Hospital of Traditional Chinese Medicine

    collaborator UNKNOWN
  • National University of Malaysia

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-08
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06587308 on ClinicalTrials.gov