Muscular Dystrophy, DuchenneNCT06363357
The Effect of a Muscle-mimicking, Fabric-type Shoulder Orthosis on Functional Movements of the Upper Limb in Patients With Neuromuscular Disorder
A study testing Shoulder orthosis in people with Muscular Dystrophy, Duchenne and Orthotic Devices, run by Seoul National University Hospital at 1 site in South Korea.
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 neuromuscular disorder. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Muscular Dystrophy, Duchenne, Orthotic Devices, Upper Extremity
- What is being tested?
- Shoulder orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Apr 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a confirmed diagnosis of a neuromuscular disease (NMD) by genetic testing, muscle biopsy, or electrodiagnostic studies, presenting with prominent upper limb muscle weakness. Examples include:
- 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.
- Aged over 10 years.
Show all 9Show fewer
- A score of 2 to 5 on the Brooke Upper Extremity Functional Rating Scale.
- Manual Muscle Test (MMT) grade of less than 3 for shoulder abduction.
- Ability to provide written informed consent from the participant and/or their legal representative, indicating willingness to participate in the study.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
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:
Read more
- 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.
- Conditions
- Muscular Dystrophy, Duchenne, Orthotic Devices, Upper Extremity, Neuromuscular Diseases (NMD), Fascioscapulohumeral Muscular Dystrophy, Spinal Muscular Atrophy (SMA)
- Being tested
- Shoulder orthosis
- Medical subject headings
- Muscular Dystrophy, Duchenne, Neuromuscular Diseases, Muscular Dystrophy, Facioscapulohumeral, Muscular Atrophy, Spinal, Amyotrophic Lateral Sclerosis, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder orthosisDevice
muscle-mimicking, fabric-type shoulder orthosis
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular disorder participants | Experimental | This study compares variables before and after wearing the shoulder orthosis in patients with neuromuscular disorder. Receives: Device: Shoulder orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before orthosis wear & After orthosis wear and operation
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.
Measured: Before orthosis wear & After orthosis wear and operation
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.
Measured: Before orthosis wear & After orthosis wear and operation
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.
Measured: Before orthosis wear & After orthosis wear and operation
Surface electromyography (sEMG)
- Measurement Tasks:
The following items are selected based on the examiner's judgment, with 3-5 items chosen for measurement:
- 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. Brushing teeth xi. Brushing front hair
- Sensor Attachment Sites:
- Selected based on the measurement task: i. Anterior/Middle Deltoid (dominant) ii. Biceps Brachii (dominant) iii. Upper Trapezius (dominant) iv. Sternocleidomastoid (dominant) v. External/Internal Oblique Muscles (both sides) vi. Longissimus muscles (both sides)
- Sensor Signal Parameters:
- EMG Parameters: Amplitude after Rectification (RMS), area, percentage ratio of amplitude to RVC during motion.
Measured: Before orthosis wear & After orthosis wear and operation
Heart rate
changes in heart rate
Measured: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)
Blood pressure
changes in blood pressure in systolic and diastolic
Measured: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)
Numeral Rating Scale for Pain
changes in pain score using Numeral Rating Scale
Measured: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)
Box and block test
A wooden box with a partition will be used with wooden blocks placed in one side of the box.
The box is placed longitudinally on a table in front of the participant. The side of the box containing 150 blocks is positioned on the side of the hand being tested.
The participant is instructed to move as many blocks as possible, one at a time, from the starting compartment to the empty compartment by reaching over the central partition, within a specified time limit.
The researcher provides a clear demonstration of the task, emphasizing that blocks must clear the partition and enter the opposite side completely.
A 15-second practice trial is administered first to ensure the participant understands the directions and task demands.
A 60-second test trial is administered for each hand, starting with the dominant hand. The stopwatch starts when the participant's hand touches the first block and stops precisely at 60 seconds.
Measured: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start20 Apr 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular Dystrophy, DuchenneStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study compares variables before and after wearing the shoulder orthosis in patients with neuromuscular disorder.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo Hyung Lee, Seoul National University Hospital
- Investigators
- Woo Hyung Lee, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363357
- Sponsor's protocol ID
- 24B-007-0000
- Status last verified
- Jul 2025
- First submitted
- 9 Apr 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Muscle-mimicking, Fabric-type Shoulder Orthosis on Functional Movements of the Upper Limb in Patients With Neuromuscular Disorder
- ClinicalTrials.gov ID
- NCT06363357
- Acronym / sponsor ID
- 24B-007-0000
- Conditions
- Muscular Dystrophy, Duchenne, Orthotic Devices, Upper Extremity, Neuromuscular Diseases (NMD), Fascioscapulohumeral Muscular Dystrophy, Spinal Muscular Atrophy (SMA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study compares variables before and after wearing the shoulder orthosis in patients with neuromuscular disorder.
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular disorder participants | Experimental | Device: Shoulder orthosisThis study compares variables before and after wearing the shoulder orthosis in patients with neuromuscular disorder. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with a confirmed diagnosis of a neuromuscular disease (NMD) by genetic testing, muscle biopsy, or electrodiagnostic studies, presenting with prominent upper limb muscle weakness. Examples include:
- Aged over 10 years.
- A score of 2 to 5 on the Brooke Upper Extremity Functional Rating Scale.
- Manual Muscle Test (MMT) grade of less than 3 for shoulder abduction.
- Ability to provide written informed consent from the participant and/or their legal representative, indicating willingness to participate in the study.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder orthosismuscle-mimicking, fabric-type shoulder orthosis | Device | Neuromuscular disorder participants |
Primary outcome
Performance of the upper limb module 2.0 (PUL 2.0)
Time frame: 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 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.
Active Range of motion
Time frame: 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/extension and abduction/adduction of the humerus are each measured three times, with the average value used.
Functional workspace
Time frame: 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.
Goal Attainment Scale (GAS)
Time frame: 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.
Surface electromyography (sEMG)
Time frame: 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. Brushing teeth xi. Brushing front hair C. Sensor Attachment Sites: - Selected based on the measurement task: i. Anterior/Middle Deltoid (dominant) ii. Biceps Brachii (dominant) iii. Upper Trapezius (dominant) iv. Sternocleidomastoid (dominant) v. External/Internal Oblique Muscles (both sides) vi. Longissimus muscles (both sides) D. Sensor Signal Parameters: - EMG Parameters: Amplitude after Rectification (RMS), area, percentage ratio of amplitude to RVC during motion.
Heart rate
Time frame: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)
changes in heart rate
Blood pressure
Time frame: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)
changes in blood pressure in systolic and diastolic
Numeral Rating Scale for Pain
Time frame: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)
changes in pain score using Numeral Rating Scale
Box and block test
Time frame: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)
A wooden box with a partition will be used with wooden blocks placed in one side of the box. The box is placed longitudinally on a table in front of the participant. The side of the box containing 150 blocks is positioned on the side of the hand being tested. The participant is instructed to move as many blocks as possible, one at a time, from the starting compartment to the empty compartment by reaching over the central partition, within a specified time limit. The researcher provides a clear demonstration of the task, emphasizing that blocks must clear the partition and enter the opposite side completely. A 15-second practice trial is administered first to ensure the participant understands the directions and task demands. A 60-second test trial is administered for each hand, starting with the dominant hand. The stopwatch starts when the participant's hand touches the first block and stops precisely at 60 seconds.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woo Hyung Lee, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder orthosis in people with Muscular Dystrophy, Duchenne and Orthotic Devices, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the upper limb module 2.0 (PUL 2.0) (time frame: Before orthosis wear & After orthosis wear and operation). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.