The Effect of a Muscle-mimicking, Fabric-type Shoulder Orthosis on Functional Movements of the Upper Limb in Patients With Duchenne Muscular Dystrophy

Seoul National University

Status: Enrolling

Conditions: Orthotic Devices; Upper Extremity; Muscular Dystrophy, Duchenne

Treatments: Device: Shoulder orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT06363357

24B-007-0000

Details and patient eligibility

About

The goal of this clinical trial is to investigate the effect of a muscle-mimicking, fabric-type shoulder orthosis on functional movements of the upper limb in patients with Duchenne muscular dystrophy.

The main questions it aims to answer are:

• What is the impact of the muscle-mimicking, fabric-type shoulder orthosis on upper limb functional movements in patients with Duchenne muscular dystrophy?
• Are there observable differences in upper limb function when the shoulder orthosis is worn versus when it is not?

Participants will:

• Receive education on how to wear and use the shoulder orthosis.
• Undergo evaluations, including assessment of upper limb performance, shoulder muscle strength testing, active range of motion measurements, assessment of functional workspace, goal attainment scale evaluation, surface electromyography, physiological measurements such as blood pressure and heart rate, fatigue assessment, and assessment for any musculoskeletal or skin-related issues.

Researchers will compare Duchenne muscular dystrophy patients before and while wearing and operating the shoulder orthosis to see if there are any significant effects on variables such as upper limb function, range of motion, functional workspace, goal attainment scale, and surface electromyography.

Enrollment: 30 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of Duchenne muscular dystrophy (DMD) through genetic testing
• Older than 10 years old
• Brooke scale score of 2-5
• Shoulder abduction muscle strength grade below 3

Exclusion criteria

• Unable or unwilling to provide informed consent
• Brooke scale score of 1 or 6
• Cognitive impairment to the extent that limits the use of the shoulder orthosis

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Duchenne muscular dystrophy participants

Experimental group

Description:

This study compares variables before and after wearing the shoulder orthosis in patients with Duchenne muscular dystrophy.

Treatment:

Device: Shoulder orthosis