Evaluating a powered exoskeleton for patients with neuromuscular disorders
Assessment of Safety and Acute Effects of a Knee-hip Powered Soft Exoskeleton in Patients With Neuromuscular Disorders
This study is testing a powered exoskeleton called MyoSuit to see if it can help people with muscle weakness from neuromuscular disorders move better and gain more independence.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Institut de Myologie, France Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05200702 on ClinicalTrials.gov |
What this trial studies
This study assesses the safety, usability, and immediate effectiveness of a powered knee-hip exoskeleton called MyoSuit in individuals with various neuromuscular disorders. It aims to establish usability criteria for the device based on patients' functional deficits and to gather data for future studies on long-term benefits of home use. The study focuses on patients who experience significant muscle weakness and reduced functional capacities due to conditions like muscular dystrophies and myopathies. By utilizing a powered assistive device, the research seeks to improve mobility and independence for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a confirmed diagnosis of specific neuromuscular or metabolic disorders and certain functional capabilities.
Not a fit: Patients who are unable to stand or walk independently, or those with severe orthopedic complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance mobility and quality of life for patients with neuromuscular disorders.
How similar studies have performed: Other studies using powered exoskeletons have shown promise in improving mobility for patients with similar conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 18 years and \< 70 years of age
* Height between 1.50 m and 1.95 m
* Weight between 45 kg and 110 kg
* Abdominal perimeter \< 125 cm
* Written informed consent
* Affiliate or beneficiary of a social security scheme
* Able to comply with all protocol requirements
* Confirmed diagnosis of a pathology belonging to one of the following family\*:
* Primary disorders of muscles
* Muscular dystrophy
* Congenital myopathies
* Idiopathic inflammatory myopathy
* Mitochondrial myopathies
* Metabolic disorders
* Inborn errors of metabolism
* Glycogen storage disease
* Functional capacities:
* Able to stand up from a chair with armrest without other supports at least 3 times and at most 15 times in 30 seconds.
* Report the ability to walk without the assistance of a person at least 2min
* The use of traditional orthoses and walking aids will be accepted excepted knee orthoses and walkers (e.g. canes/crutches, ankle foot orthosis).
Exclusion Criteria:
* Unable to participate in the study
* Inability to comply with protocol requirements
* Guardianship/trusteeship
* Pregnant or nursing women
* Unstable Cardiomyopathy
* Symptomatic orthostatic hypotension
* Medical history of osteoporotic fracture
* Balance disorder with extra neuromuscular causes
* Recent trauma (fall, accident, ...)
* Unstable Cardiomyopathy
* Severe respiratory insufficiency
* Flexion contracture in the knee and hip joint in excess of 10°
* Varus malposition in excess of 10° or valgus malposition in excess of 10°
Where this trial is running
Paris
- Institute of Myology — Paris, France (Recruiting)
Study contacts
- Study coordinator: Guillaume Bassez, MD
- Email: guillaume.bassez@aphp.fr
- Phone: 01 42 16 66 43
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.