Actively Recruiting

Phase Not Applicable
Age: 10Years +
All Genders
ID06363357

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

Led by Seoul National University Hospital · Updated on 2025-12-03

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how a muscle-mimicking, fabric-type shoulder orthosis affects upper limb functional movements in patients with neuromuscular disorders. The study aims to understand if wearing this shoulder orthosis changes upper limb function, range of motion, and muscle activity compared to not wearing it. This research is important for patients with conditions such as muscular dystrophies, motor neuron diseases, peripheral neuropathies, and spinal cord injuries who experience upper limb muscle weakness. Participants will use the shoulder orthosis device, which mimics muscle function, and receive education on how to wear and operate it. The study compares various measurements before and after wearing the orthosis. These include upper limb performance, shoulder muscle strength, active range of motion, functional workspace, goal attainment, surface electromyography, heart rate, blood pressure, pain levels, and hand dexterity tests. During the study, participants will undergo multiple assessments to evaluate upper limb movement and physiological responses. Researchers will monitor muscle activity and function with and without the orthosis in place. Participants will be observed while performing standard tasks lasting approximately 3 to 4 hours. The study includes safety checks for any musculoskeletal or skin issues and fatigue evaluations. The total participation time and follow-up details are based on these evaluations to determine the orthosis's impact.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 10Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a confirmed diagnosis of a neuromuscular disease by genetic testing, muscle biopsy, or electrodiagnostic studies, showing significant upper limb muscle weakness, including muscular dystrophies, motor neuron diseases, peripheral neuropathies, or cervical spinal cord injury
  • Age 10 years or older
  • Brooke Upper Extremity Functional Rating Scale score between 2 and 5
  • Manual Muscle Test grade less than 3 for shoulder abduction
  • Ability to provide written informed consent from the participant or legal representative indicating willingness to participate
Not Eligible

You will not qualify if you...

  • Unwillingness or inability to provide informed consent
  • Brooke Upper Extremity Functional Rating Scale score of 1 or 6
  • Severe cognitive impairment interfering with proper use of the shoulder orthosis
  • Any condition deemed by the investigator to make participation inappropriate or unsafe

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Approximately 3 to 4 hours on the day of orthosis wear

Participants wear the muscle-mimicking, fabric-type shoulder orthosis and undergo assessments before and after use to evaluate functional movements of the upper limb.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Seoul National University Hospital

Seoul, Jongno-gu, South Korea, 03080

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Research Team

S

Sungbae Jo, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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