Status:
UNKNOWN
Assessment of Safety and Acute Effects of a Lower-limb Powered Dermoskeleton 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 programmable ambulation exoskeleton (KeeogoTM Dermoskeleton System, B-Temia Inc., Quebec, Can...
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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05199246
Start Date
December 1 2021
End Date
July 1 2024
Last Update
September 28 2023
Active Locations (1)
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1
Institute of Myology
Paris, France, 75013