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

NCT ID: NCT06363357

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2025-12-31

Brief Summary

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 neuromuscular disorder.

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 neuromuscular disorder?
• 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 neuromuscular disorder 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.

Conditions

Muscular Dystrophy, Duchenne; Orthotic Devices; Upper Extremity; Neuromuscular Diseases (NMD); Fascioscapulohumeral Muscular Dystrophy; Spinal Muscular Atrophy (SMA); ALS (Amyotrophic Lateral Sclerosis); LGMD; SCI - Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Neuromuscular disorder participants

This study compares variables before and after wearing the shoulder orthosis in patients with neuromuscular disorder.

Group Type: EXPERIMENTAL

Shoulder orthosis

Intervention Type: DEVICE

muscle-mimicking, fabric-type shoulder orthosis

Interventions

Shoulder orthosis

muscle-mimicking, fabric-type shoulder orthosis

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients with a confirmed diagnosis of a neuromuscular disease (NMD) by genetic testing, muscle biopsy, or electrodiagnostic studies, presenting with prominent upper limb muscle weakness. Examples include:

1. Muscular Dystrophies: Duchenne/Becker Muscular Dystrophy (DMD/BMD), Limb-Girdle Muscular Dystrophy (LGMD), Facioscapulohumeral Muscular Dystrophy (FSHD), etc.

2. Motor Neuron Diseases: Spinal Muscular Atrophy (SMA, Types 2 and 3), Amyotrophic Lateral Sclerosis (ALS, upper limb-dominant), etc.

3. Peripheral Neuropathies: Charcot-Marie-Tooth (CMT) disease, etc.

4. Other Neuromuscular Conditions: Including but not limited to cervical spinal cord injury.

2. Aged over 10 years.

3. A score of 2 to 5 on the Brooke Upper Extremity Functional Rating Scale.

4. Manual Muscle Test (MMT) grade of less than 3 for shoulder abduction.

5. Ability to provide written informed consent from the participant and/or their legal representative, indicating willingness to participate in the study.

Exclusion Criteria

1. Unwillingness or inability to provide informed consent.

2. A score of 1 or 6 on the Brooke Upper Extremity Functional Rating Scale.

3. Cognitive impairment severe enough to interfere with the proper use of a shoulder orthosis.

4. Any other condition which, in the opinion of the investigator, would make study participation inappropriate or unsafe for the patient.

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Woo Hyung Lee

Assistant professor (MD, PhD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Woo Hyung Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sungbae Jo, PhD

Role: CONTACT

sungbaejo@snuh.org

+82-10-9381-2299

Facility Contacts

Woo Hyung Lee, MD, Ph.D

Role: primary

whlee909@snu.ac.kr

+82-2-2072-4178

Other Identifiers

24B-007-0000

Identifier Type: -

Identifier Source: org_study_id