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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Page 1 of 1 (1 locations)

1

Wandercraft

Paris, France, 75004

Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population | DecenTrialz