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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNational University of Malaysia

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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.

Treatment groups

165 Participants
are divided into 3 treatment groups
Group A: Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure GarmentExperimental treatment 1 intervention
Group B: Single-Layered 10% Circumferential Reduction (S-10) Pressure GarmentActive comparator 1 intervention
Group C: Single-Layered No Circumferential Reduction (S-0) Pressure GarmentPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline, Week 4. Week 8

Secondary outcomes

1

Modified Ashworth Scale (MAS)

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.

Time frame
Baseline, Week 4. Week 8
2

Visual Analogue Scale (VAS)

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.

Time frame
Baseline, Week 4. Week 8
3

Box and Block Test (BBT)

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.

Time frame
Baseline, Week 4. Week 8
4

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

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.

Time frame
Baseline, Week 4. Week 8

Other outcomes

1

Brunnstrom Recovery Stage (BRS)

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.

Time frame
Prior to participant enrolment
2

Modified Ashworth Score (MAS)

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..

Time frame
Prior to participant enrolment
3

Saint Louis University Mental Status (SLUMS) Examination

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.

Time frame
Prior to participant enrolment

Sponsors and contacts

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National University of Malaysia

Lead sponsor

The Affiliated Hospital of Shandong Second Medical University

Collaborator

Weifang Municipal People's Hospital

Collaborator

Weifang Hospital of Traditional Chinese Medicine

Collaborator