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

Muscular Dystrophy, Duchenne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06363357
• Other study ID #: 24B-007-0000
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Seoul National University Hospital
• Contact: Sungbae Jo, PhD
• Phone: +82-10-9381-2299
• Email: sungbaejo[@]snuh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Orthotic Devices
• Upper Extremity

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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.	Before orthosis wear & After orthosis wear and operation
Primary	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 and abduction of the humerus are each measured three times, with the average value used.	Before orthosis wear & After orthosis wear and operation
Primary	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.	Before orthosis wear & After orthosis wear and operation
Primary	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.	Before orthosis wear & After orthosis wear and operation
Primary	Surface electromyography (sEMG)	- 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.	Before orthosis wear & After orthosis wear and operation