Atalante USAbility

NCT05284708 | Completed DMC FDA Device

• 1 other identifier: CIP003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia

Keywords

Exoskeleton

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Observational Usability - Non-Critical Tasks and IFU and training assessment

  10.5 hours

Study Arms (1)

Clinical Operators

OTHER

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

Interventions

Atalante DEVICE

Powered Exoskeleton

Clinical Operators

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wandercraft: lead
• Innovative Medical Technologies, Inc: collaborator
• Shirley Ryan AbilityLab: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Related Links

• M4 Study
• SPIRIT Study
• INSPIRE Study

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arun Jayaraman, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Usability Observational Study, Operators

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: March 17, 2022
• Study Start: November 29, 2021
• Primary Completion: December 17, 2021
• Study Completion: January 10, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)