Clinical trial NCT06363357: The Effect of a Muscle-mimicking, Fabric-type Shoulder Orthosis on Functional Movements of the Upper Limb in Patients With Duchenne Muscular Dystrophy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Muscular Dystrophy, Duchenne
Orthotic Devices
Upper Extremity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study compares variables before and after wearing the shoulder orthosis in patients with Duchenne muscular dystrophy.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Performance of the upper limb module 2.0 (PUL 2.0)
timeFrame: Before orthosis wear & After orthosis wear and operation
measure: Active Range of motion
timeFrame: Before orthosis wear & After orthosis wear and operation
measure: Functional workspace
timeFrame: Before orthosis wear & After orthosis wear and operation
measure: Goal Attainment Scale (GAS)
timeFrame: Before orthosis wear & After orthosis wear and operation
measure: Surface electromyography (sEMG)
timeFrame: Before orthosis wear & After orthosis wear and operation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Woo Hyung Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: