Assessment of Safety and Acute Effects of a Lower-limb Powered Dermoskeleton in Patients With Neu… (NCT05199246) | Clinical Trial Compass
CompletedNot Applicable
Assessment of Safety and Acute Effects of a Lower-limb Powered Dermoskeleton in Patients With Neuromuscular Disorders
France50 participantsStarted 2021-12-01
Plain-language 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, Canada) 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 range
18 Years – 70 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:
* 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
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.
1This trial tested a powered lower-limb exoskeleton in people with conditions like muscular dystrophy and congenital myopathy — given my specific diagnosis, would my muscle weakness pattern and level of mobility make me a reasonable candidate to discuss this kind of device?
2The trial's main goal was checking whether the exoskeleton caused any harmful effects during use — now that it's completed, has the safety data been published, and what kinds of adverse events, if any, were actually observed in participants?
3Since this was a study of acute, short-term effects rather than long-term outcomes, what do we still not know about whether a powered exoskeleton like this would be safe or beneficial for someone with my condition over months or years of use?
4My condition may affect not just my legs but also my breathing or heart muscles — are there specific aspects of my neuromuscular diagnosis that would make using a lower-limb powered exoskeleton riskier for me than it might be for other participants in this trial?
5If the safety results from this trial look promising, are there follow-up studies or clinical programs testing this type of exoskeleton that might now be open to enroll, and would it be worth exploring those as a next step together?
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
Absence of adverse effect attributable to the use of the device during task performed within a lower-limb powered dermoskeleton
Timeframe: Through study completion, on average 4 weeks