Effect of a shoulder orthosis on upper limb function in Duchenne muscular dystrophy

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

This study tests if wearing a special shoulder support can help improve arm movement and strength in people with Duchenne muscular dystrophy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 10 Years and up
• Sex: All
• Sponsor: Seoul National University Hospital (other)
• Locations: 1 site (Seoul, Jongno-gu)
• Trial ID: NCT06363357 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates how a muscle-mimicking, fabric-type shoulder orthosis affects the functional movements of the upper limb in patients diagnosed with Duchenne muscular dystrophy. Participants will be educated on the use of the orthosis and undergo various evaluations, including assessments of upper limb performance, muscle strength, range of motion, and physiological measurements. The study aims to determine the differences in upper limb function when the orthosis is worn compared to when it is not.

Who should consider this trial

Good fit: Ideal candidates are individuals over 10 years old with a confirmed diagnosis of Duchenne muscular dystrophy and specific muscle strength limitations.

Not a fit: Patients with a Brooke scale score of 1 or 6, or those with cognitive impairments that limit the use of the orthosis, may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could enhance upper limb functionality and quality of life for patients with Duchenne muscular dystrophy.

How similar studies have performed: While similar approaches have been explored, this specific intervention using a muscle-mimicking shoulder orthosis is relatively novel.

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.

Where this trial is running

Seoul, Jongno-gu

• Seoul National University Hospital — Seoul, Jongno-gu, South Korea (RECRUITING)

Study contacts

• Principal investigator: Woo Hyung Lee, MD, PhD — Seoul National University Hospital
• Study coordinator: Sungbae Jo, PhD

Conditions: Muscular Dystrophy, Duchenne, Orthotic Devices, Upper Extremity, Neuromuscular Diseases, Fascioscapulohumeral Muscular Dystrophy, Spinal Muscular Atrophy, ALS, LGMD