Assessment of Safety and Acute Effects of a Lower-limb Powered Dermoskeleton in Patients With Neuromuscular Disorders

Launched by INSTITUT DE MYOLOGIE, FRANCE · Jan 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Keeogo™ Dermoskeleton, which is designed to help people with neuromuscular disorders walk more easily. The aim is to assess how safe and effective this exoskeleton is for patients with conditions like muscular dystrophies and mitochondrial myopathies. The researchers want to understand how well the device works in real-world situations and gather information that could lead to future studies on its long-term use at home.

To participate in the trial, individuals must be between 18 and 70 years old, weigh between 45 and 110 kg, and be able to stand up from a chair and walk independently for at least 2 minutes. Participants will receive training on how to use the device and will be monitored closely during the trial. It’s important to note that certain health conditions, like severe heart or respiratory issues, may prevent someone from joining. Overall, this study is an exciting opportunity for eligible patients to potentially improve their mobility and help researchers learn more about this innovative technology.

Gender

ALL

Eligibility 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