The Effect of a Muscle-mimicking, Fabric-type Shoulder Orthosis on Functional Movements of the Up… (NCT06363357) | Clinical Trial Compass
RecruitingNot Applicable
The Effect of a Muscle-mimicking, Fabric-type Shoulder Orthosis on Functional Movements of the Upper Limb in Patients With Neuromuscular Disorder
South Korea30 participantsStarted 2024-04-20
Plain-language 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.
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.
Who can participate
Age range
10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Performance of the upper limb module 2.0 (PUL 2.0)
Timeframe: Before orthosis wear & After orthosis wear and operation
2
Active Range of motion
Timeframe: Before orthosis wear & After orthosis wear and operation
3
Functional workspace
Timeframe: Before orthosis wear & After orthosis wear and operation
4
Goal Attainment Scale (GAS)
Timeframe: Before orthosis wear & After orthosis wear and operation
5
Surface electromyography (sEMG)
Timeframe: Before orthosis wear & After orthosis wear and operation
6
Heart rate
Timeframe: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)
7
Blood pressure
Timeframe: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)