Assessment of Safety and Acute Effects of a Knee-hip Powered Soft Exoskeleton in Patients With Ne… (NCT05200702) | Clinical Trial Compass
CompletedNot Applicable
Assessment of Safety and Acute Effects of a Knee-hip Powered Soft Exoskeleton in Patients With Neuromuscular Disorders
France32 participantsStarted 2022-01-05
Plain-language 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 neuromuscular disorders, ii) Elaborate recommendations regarding usability criteria for safe and efficient use the device in patients with neuromuscular disorders (e.g. type and severity of patient's functional deficits), iii) generate necessary data to foresee a future study involving a home use of the device and assessment of long-term benefits.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 exc…
What they're measuring
1
Absence of adverse effect attributable to the use of the device during task performed within a knee-hip powered soft exoskeleton
Timeframe: Through study completion, on average 4 weeks