Atalante USAbility

The "USAbility" Study - Human Factor Validation Testing of the Atalante Exoskeleton

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.

Study Overview

• Status: Completed
• Conditions: Hemiplegia
• Intervention / Treatment: Device: Atalante

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:

1. IFU questionnaire
2. 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*.

3. 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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan AbilityLab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Clinical Operators; 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.	Device: Atalante; Powered Exoskeleton

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10.5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10.5 hours

Collaborators and Investigators

• Sponsor: Wandercraft
• Collaborators: Shirley Ryan AbilityLab; Innovative Medical Technologies, Inc
• Investigators: Principal Investigator: Arun Jayaraman, PhD, Shirley Ryan AbilityLab

Publications and helpful links

Helpful Links

• M4 Study
• SPIRIT Study
• INSPIRE Study

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Actual): December 17, 2021
• Study Completion (Actual): January 10, 2022

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Exoskeleton
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Hemiplegia
• Other Study ID Numbers: CIP003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No