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

National University of Malaysia

Status: Enrolling

Conditions: Cerebral Vascular Accident (CVA)/Stroke

Treatments: Other: Single-Layered No Circumferential Reduction (S-0) Pressure Garment; Other: Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment; Other: Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment

Study type: Interventional

Funder types: Other

Identifiers

NCT06587308

JEP-2024-582

Details and patient eligibility

About

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).

Enrollment: 165 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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165 participants in 3 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

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

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

Active Comparator group

Description:

A custom-fabricated single-layered finger-to-above-elbow (long glove) pressure garment with 10% of stress.

Treatment:

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

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

Placebo Comparator group

Description:

A custom-fabricated single-layered finger-to-above-elbow (long glove) pressure garment with 0% of stress

Treatment:

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