Atalante USAbility
Primary Purpose
Hemiplegia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Atalante
Sponsored by
About this trial
This is an interventional other trial for Hemiplegia focused on measuring Exoskeleton
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Sites / Locations
- Shirley Ryan AbilityLab
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Clinical Operators
Arm Description
Experimental: 15 healthcare professionals will be recruited for the study. The group includes physiotherapists (PTs), physiotherapist assistants (PTAs), clinical exercise physiologists (EPs), and rehabilitation technicians (RTs), all resident in US and representing the final users of the device. Operators are representative of the final users of the exoskeleton.
Outcomes
Primary Outcome Measures
Observational Usability - Critical Tasks
The primary usability objective that will serve as acceptance criterion for this test is 100% of recruited operators complete each of the critical tasks successfully.
Secondary Outcome Measures
Observational Usability - Non-Critical Tasks and IFU and training assessment
Secondary Outcome Measures include 90% of recruited operators can respond to the IFU questionnaire correctly and is considered "passed" if the operator can correctly answer 9 out 10 questions in the provided time and 90% of recruited operators can complete each of the non-critical tasks successfully and 90% of recruited operators rates the training and associated documents as 3 or higher on a 5-point scale.
Full Information
NCT ID
NCT05284708
First Posted
November 23, 2021
Last Updated
March 8, 2022
Sponsor
Wandercraft
Collaborators
Innovative Medical Technologies, Inc, Shirley Ryan AbilityLab
1. Study Identification
Unique Protocol Identification Number
NCT05284708
Brief Title
Atalante USAbility
Official Title
The "USAbility" Study - Human Factor Validation Testing of the Atalante Exoskeleton
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
December 17, 2021 (Actual)
Study Completion Date
January 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wandercraft
Collaborators
Innovative Medical Technologies, Inc, Shirley Ryan AbilityLab
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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 the intended uses and under the expected use conditions.
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 widespread adoption of robotic devices (e.g., exoskeletons) in clinical routine Their success is highly dependent on user acceptance, which in turn is determined by the subjective intention-to-use, as well as by the perception of usability and comfort. Approaching the design of such devices with Human Factors and Usability engineering has proven to be an effective means to enhance performance-related outcomes such as fewer errors, less time and lower mental effort. Usability testing is commonly considered a cornerstone in user-centered design, as it provides information about problematic design issues. It further serves as a validation test for performance requirements, such as efficiency or safety of operation.
Based on these considerations, we propose a study to analyze the usability of Atalante device and demonstrate that it can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions. The scope of this research study is to validate all the critical tasks performed by the intended operators of the device in a typical rehabilitation session according to IEC 62366-1(2020) and the FDA Guidance "Applying human Factors and Usability Engineering to Medical Devices". This knowledge will inform further development of exoskeletons and improve the widespread uptake and medical use of such devices, in light of the many benefits that these technologies can bring to future patients.
15 operators will be recruited and attend an 8 hours and 30 minutes training split in three days and provided by Wandercraft before the use of the device.
Usability will be assessed by:
IFU questionnaire
Simulated tasks test: users' performance will be observed to determine if the assigned task was performed correctly by the operator. 5 patients will be recruited to simulate a typical session with the exoskeleton*.
Final debriefing: subjective operators' assessments will be collected after the test The device user interfaces represent the final design of the device, and the study will be performed in actual conditions of use at the Shirley Ryan Ability Lab, a physical medicine and rehabilitation research hospital based in Chicago, Illinois, USA which is representative of the intended use environment.
Patients performance is out of the scope of the evaluation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia
Keywords
Exoskeleton
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Usability Observational Study, Operators
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinical Operators
Arm Type
Other
Arm Description
Experimental: 15 healthcare professionals will be recruited for the study. The group includes physiotherapists (PTs), physiotherapist assistants (PTAs), clinical exercise physiologists (EPs), and rehabilitation technicians (RTs), all resident in US and representing the final users of the device. Operators are representative of the final users of the exoskeleton.
Intervention Type
Device
Intervention Name(s)
Atalante
Intervention Description
Powered Exoskeleton
Primary Outcome Measure Information:
Title
Observational Usability - Critical Tasks
Description
The primary usability objective that will serve as acceptance criterion for this test is 100% of recruited operators complete each of the critical tasks successfully.
Time Frame
10.5 hours
Secondary Outcome Measure Information:
Title
Observational Usability - Non-Critical Tasks and IFU and training assessment
Description
Secondary Outcome Measures include 90% of recruited operators can respond to the IFU questionnaire correctly and is considered "passed" if the operator can correctly answer 9 out 10 questions in the provided time and 90% of recruited operators can complete each of the non-critical tasks successfully and 90% of recruited operators rates the training and associated documents as 3 or higher on a 5-point scale.
Time Frame
10.5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arun Jayaraman, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT04110561?term=atalante+exoskeleton&draw=2&rank=3
Description
M4 Study
URL
https://clinicaltrials.gov/ct2/show/NCT04187209?term=atalante+exoskeleton&draw=2&rank=2
Description
SPIRIT Study
URL
https://clinicaltrials.gov/ct2/show/NCT04694001?term=atalante+exoskeleton&draw=2&rank=1
Description
INSPIRE Study
Learn more about this trial
Atalante USAbility
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