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

Not Applicable

Recruiting

• Conditions: Muscular Dystrophy, Duchenne; Upper Extremity; Orthotic Devices
• Interventions: Device: Shoulder orthosis

• Registration Number: NCT06363357
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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 Duchenne muscular dystrophy.

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 Duchenne muscular dystrophy?

* 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 Duchenne muscular dystrophy 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-12
• Study Start: 2024-04-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Confirmed diagnosis of Duchenne muscular dystrophy (DMD) through genetic testing
• Older than 10 years old
• Brooke scale score of 2-5
• Shoulder abduction muscle strength grade below 3

Exclusion Criteria

• Unable or unwilling to provide informed consent
• Brooke scale score of 1 or 6
• Cognitive impairment to the extent that limits the use of the shoulder orthosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duchenne muscular dystrophy participants	Shoulder orthosis	This study compares variables before and after wearing the shoulder orthosis in patients with Duchenne muscular dystrophy.

Primary Outcome Measures

Name	Time	Method
Goal Attainment Scale (GAS)	Before orthosis wear & After orthosis wear and operation	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.
Performance of the upper limb module 2.0 (PUL 2.0)	Before orthosis wear & After orthosis wear and operation	The Performance of the Upper Limb module (PUL) was specifically designed to assess upper limb function across the spectrum of function in patients with DMD, 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.
Active Range of motion	Before orthosis wear & After orthosis wear and operation	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 and abduction of the humerus are each measured three times, with the average value used.
Functional workspace	Before orthosis wear & After orthosis wear and operation	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.
Surface electromyography (sEMG)	Before orthosis wear & After orthosis wear and operation	- Measurement Tasks: The following items are selected based on the examiner's judgment, with 3-5 items chosen for measurement: i. Shoulder abduction with both arms raised above the head ii. Shoulder height arm raising (based on elbow position) iii. Shoulder flexion at shoulder height iv. Moving wooden blocks v. Pouring water into a cup vi. Placing hand on the abdomen vii. Placing hand in the back pocket viii. Placing hand on the shoulder of the same side ix. Placing hand on the shoulder of the opposite side x. Placing hand on the mouth xi. Placing hand on the top of the head xii. Placing hand on the back of the head; C. Sensor Attachment Sites: - Selected based on the measurement task: i. Deltoid ii. Pectoralis major iii. Trapezius; D. Sensor Signal Parameters: - EMG Parameters: Amplitude after Rectification (RMS), area, percentage ratio of amplitude to MVC, percentage ratio of amplitude to RVC during motion.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of