Status:
COMPLETED
Atalante USAbility
Lead Sponsor:
Wandercraft
Collaborating Sponsors:
Innovative Medical Technologies, Inc
Shirley Ryan AbilityLab
Conditions:
Hemiplegia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The "USAbility" study - Human Factor Validation Testing of the Atalante exoskeleton aims at demonstrating that Atalante can be used by the intended users without serious use errors or problems, for th...
Detailed Description
Robotic assisted rehabilitation has been successfully proposed and employed especially when motor conditions do not allow the patient to walk. However, limitations in usability often prevent from a wi...
Eligibility Criteria
Inclusion
- Operators\*
- Operators belonging to one of the following categories:
- Physiotherapists
- Physiotherapist assistants
- Exercise physiologists
- Rehabilitation technicians
- Operators are US residents
- Operators can speak, write, and understand English
- Need for supervision for specific operators' categories is regulated by the specific state laws and jurisdiction and is part of the responsibility of the healthcare facility.
- Patients:
- Aged 18 and over
- More than 30 days post stroke
- English speakers: able to read, understand, and sign the informed consent
- With specific morphological characteristics
Exclusion
- Patients:
- Individuals with severe spasticity of adductor muscles, hamstring, quadriceps, and triceps surrae. Severe spasticity is defined by a score greater than 3 on the modified Ashworth scale
- Pregnant women
- History(ies) of osteoporotic fracture(s) and/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 system
- Cognitive impairment that prevents the patient from understanding instructions, at the physician's discretion
Key Trial Info
Start Date :
November 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05284708
Start Date
November 29 2021
End Date
January 10 2022
Last Update
March 17 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611