Status:
UNKNOWN
Assessment of Safety and Acute Effects of a Knee-hip Powered Soft Exoskeleton in Patients With Neuromuscular Disorders
Lead Sponsor:
Institut de Myologie, France
Conditions:
Muscular Dystrophies
Congenital Myopathy
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The aims of the current study are as follow: i) Evaluate the safety, usability, and acute efficiency of a powered knee-hip dermoskeleton (MyoSuit, MyoSwiss, Zurich, Switzerland) in patients with neur...
Detailed Description
Patients with neuromuscular disorders display different type of symptoms depending on the type of pathology. Diseases like facioscapulohumeral dystrophy (FSHD), limb-girdle muscular dystrophy (LGMD2b)...
Eligibility Criteria
Inclusion
- 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
- 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°
Key Trial Info
Start Date :
January 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05200702
Start Date
January 5 2022
End Date
July 1 2024
Last Update
September 28 2023
Active Locations (1)
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1
Institute of Myology
Paris, France, 75013