Status:
RECRUITING
Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population
Lead Sponsor:
Wandercraft
Conditions:
Motor Disorders
Gait Disorders, Neurologic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In 2019, approximately 2.4 billion people worldwide required rehabilitation for various health pathologies, a 63% increase since 1990. It has been suggested that current rehabilitation frameworks (inp...
Eligibility Criteria
Inclusion
- Patient suffering from lower limb weaknesses and / or deficiencies regardless of the cause
- Adult patient ≥18 years old
- Patient able to read and write in French and who have signed an informed consent form
- Patient affiliated to a social security system.
Exclusion
- Individual with severe spasticity of adductor muscles, hamstring, quadriceps and triceps surae. Severe spasticity is defined by a score of 4 on the modified Ashworth scale
- Pregnant woman
- Individual with history of osteoporotic fracture and / or pathology or treatment causing secondary osteoporosis
- Pressure Ulcer of Grade I or higher according to the NPUAP International Pressure Ulcer Classification System- EPUAP, in areas of contact with the Atalante X system
- Severe aphasia limiting ability to express needs or to fulfil questionnaires, at the discretion of the physician.
- Patient with a cardiac or respiratory contraindication to physical exertion, at discretion of the physician
- Patient unable to deliver his/her consent
- Patient under legal protection
- Patient participating at the same time in another study
- Patients with morphological contraindications to the use of the Atalante X exoskeleton (as per user's manual) with exceptions as follows: knee flessum of 20° authorized if sensibility is present; equinus of the ankle of 20° allowed regardless of presence or absence of sensibility, hip flessum of 20° allowed regardless of presence or absence of sensibility.
Key Trial Info
Start Date :
February 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 2 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06538974
Start Date
February 16 2023
End Date
July 2 2027
Last Update
August 6 2024
Active Locations (1)
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1
Wandercraft
Paris, France, 75004