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Recruiting NCT06363357

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

No phase Interventional Muscular Dystrophy, Duchenne Orthotic Devices Upper Extremity Neuromuscular Diseases (NMD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Shoulder orthosis.
Who it may be relevant to
Registry conditions: Muscular Dystrophy, Duchenne, Orthotic Devices, Upper Extremity, Neuromuscular Diseases (NMD). Basic parameters: from 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Shoulder orthosis
    muscle-mimicking, fabric-type shoulder orthosis

Primary outcome measures

  • Performance of the upper limb module 2.0 (PUL 2.0) [Time frame: Before orthosis wear & After orthosis wear and operation]
  • Active Range of motion [Time frame: Before orthosis wear & After orthosis wear and operation]
  • Functional workspace [Time frame: Before orthosis wear & After orthosis wear and operation]
  • Goal Attainment Scale (GAS) [Time frame: Before orthosis wear & After orthosis wear and operation]
  • Surface electromyography (sEMG) [Time frame: Before orthosis wear & After orthosis wear and operation]
  • Heart rate [Time frame: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)]
  • Blood pressure [Time frame: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)]
  • Numeral Rating Scale for Pain [Time frame: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)]
  • Box and block test [Time frame: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)]

Eligibility criteria

Inclusion criteria

  • 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:
  • Muscular Dystrophies: Duchenne/Becker Muscular Dystrophy (DMD/BMD), Limb-Girdle Muscular Dystrophy (LGMD), Facioscapulohumeral Muscular Dystrophy (FSHD), etc.
  • Motor Neuron Diseases: Spinal Muscular Atrophy (SMA, Types 2 and 3), Amyotrophic Lateral Sclerosis (ALS, upper limb-dominant), etc.
  • Peripheral Neuropathies: Charcot-Marie-Tooth (CMT) disease, etc.
  • Other Neuromuscular Conditions: Including but not limited to cervical spinal cord injury.
  • Aged over 10 years.
  • A score of 2 to 5 on the Brooke Upper Extremity Functional Rating Scale.
  • Manual Muscle Test (MMT) grade of less than 3 for shoulder abduction.
  • Ability to provide written informed consent from the participant and/or their legal representative, indicating willingness to participate in the study.

Exclusion criteria

  • Unwillingness or inability to provide informed consent.
  • A score of 1 or 6 on the Brooke Upper Extremity Functional Rating Scale.
  • Cognitive impairment severe enough to interfere with the proper use of a shoulder orthosis.
  • Any other condition which, in the opinion of the investigator, would make study participation inappropriate or unsafe for the patient.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT06363357 · 24B-007-0000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗