Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT06363357
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT06363357
Study Brief:
Protocol Section:
NCT06363357