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

ConditionsMuscular Dystrophy, DuchenneOrthotic DevicesUpper ExtremityNeuromuscular Diseases (NMD)Fascioscapulohumeral Muscular DystrophySpinal Muscular Atrophy (SMA)ALS (Amyotrophic Lateral Sclerosis)LGMDSCI - Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10+
SponsorSeoul National University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Shoulder orthosis

    Device

    muscle-mimicking, fabric-type shoulder orthosis

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Neuromuscular disorder participantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Performance of the upper limb module 2.0 (PUL 2.0)

The Performance of the Upper Limb module (PUL) was specifically designed to assess upper limb function across the spectrum of function in patients with neuromuscular disorder, providing information on three domains of upper limb function (shoulder, middle, distal) and overall upper limb functional abilities. Each domain (shoulder, middle, distal) can be scored separately, and the scores from the three levels are summed up to a maximum of 44 points.

Time frame
Before orthosis wear & After orthosis wear and operation
2

Active Range of motion

Measurement of range of motion is assessed using a goniometer, with the evaluator measuring the active range of motion of the shoulder joint in the same position before and after orthosis wear using the same tool. The measurement is taken with the trunk as the center, and the flexion/extension and abduction/adduction of the humerus are each measured three times, with the average value used.

Time frame
Before orthosis wear & After orthosis wear and operation
3

Functional workspace

Functional workspace analysis consists of 7 movements, where participants are asked to touch specific body parts in sequence: 1. Belly button, 2. Back pocket, 3. Same-side shoulder, 4. Opposite-side shoulder, 5. Mouth, 6. Top of head, 7. Back of head using both right and left hands. Analysis of functional workspace is manually performed based on recordings from 2 video cameras. Scores are assigned on a 4-point scale: 0 indicates inability to perform the task, 1 indicates reaching 0-49% of the target location, 2 indicates reaching 50-99% of the target location, and 3 indicates reaching the target location completely. Cumulative scores are calculated for all movements.

Time frame
Before orthosis wear & After orthosis wear and operation
4

Goal Attainment Scale (GAS)

Setting GAS goals is based on selecting the three most urgent issues among the problems the patient has based on the initial clinical assessment scores, with sufficient consideration given to the opinions of the patient and caregivers through interviews. Subsequently, three specific goals are selected based on the most urgent problems identified by the research team meeting.

Time frame
Before orthosis wear & After orthosis wear and operation

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Source ClinicalTrials.gov
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