Assessment of Safety and Acute Effects of a Knee-hip Powered Soft Exoskeleton in Patients With Neuromuscular Disorders

Launched by INSTITUT DE MYOLOGIE, FRANCE · Jan 20, 2022

Keywords

ClinConnect Summary

This clinical trial is testing a special device called a powered knee-hip exoskeleton, designed to help people with neuromuscular disorders, which are conditions that affect muscle strength and movement. The goal is to see if this device is safe to use and how well it works to assist patients during activities, such as standing and walking. Researchers want to gather information that will help them make recommendations for safe use of the device and plan for future studies on its long-term benefits at home.

To participate in the trial, you need to be between 18 and 70 years old, weigh between 45 and 110 kg, and be able to stand up from a chair and walk without help for a short time. If you have a condition such as muscular dystrophy or other specific muscle disorders, you may qualify. Participants will have the chance to try the exoskeleton and share their experiences, which will help improve how it is used for people with similar conditions in the future. If you have certain health issues, such as severe heart problems or balance disorders, you might not be able to take part in this study.

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
• • 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°