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

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Apr 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a special shoulder device designed to help improve arm movements in patients with Duchenne muscular dystrophy, a condition that weakens muscles over time. The researchers want to find out how wearing this fabric-type shoulder orthosis affects how well patients can move their arms and if there are noticeable differences in their upper limb function when they wear it compared to when they don’t.

To participate, you must be over 10 years old and have a confirmed diagnosis of Duchenne muscular dystrophy. During the trial, participants will receive guidance on how to use the shoulder device and will undergo several tests to measure their arm strength, movement range, and overall function. The study is currently recruiting participants of all genders, and it aims to gather important information that could help improve the daily lives of those living with this condition.

Gender

ALL

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.