HemiplegiaNCT05284708
Atalante USAbility
A study testing Atalante in people with Hemiplegia, run by Wandercraft at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemiplegia
- What is being tested?
- Atalante
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2021to 10 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Operators
- Operators belonging to one of the following categories:
- Physiotherapists
- Physiotherapist assistants
- Exercise physiologists
- Rehabilitation technicians
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Hemiplegia
- Being tested
- Atalante
- Keywords
- Exoskeleton
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtalanteDevice
Powered Exoskeleton
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Atalante |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10.5 hours
Secondary outcomes (1)
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.
Measured: 10.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start29 Nov 2021
- Primary completion17 Dec 2021
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Usability Observational Study, Operators
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wandercraft
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovative Medical Technologies, Inc, Shirley Ryan AbilityLab
- Responsible party
- Sponsor
- Investigators
- Arun Jayaraman, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284708
- Sponsor's protocol ID
- CIP003
- Status last verified
- Mar 2022
- First submitted
- 23 Nov 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "USAbility" Study - Human Factor Validation Testing of the Atalante Exoskeleton
- ClinicalTrials.gov ID
- NCT05284708
- Acronym / sponsor ID
- CIP003
- Conditions
- Hemiplegia
- Keywords
- Exoskeleton
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- WandercraftIndustry (pharma, biotech, devices)
- Collaborators
- Innovative Medical Technologies, Inc, Shirley Ryan AbilityLab
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Usability Observational Study, Operators
| Arm | Type | Receives |
|---|---|---|
| Clinical Operators | Other | Device: AtalanteExperimental: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Operators
- Operators belonging to one of the following categories:
- Operators are US residents
- Operators can speak, write, and understand English
- Aged 18 and over
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtalantePowered Exoskeleton | Device | Clinical Operators |
Primary outcome
Observational Usability - Critical Tasks
Time frame: 10.5 hours
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.
1 secondary outcome
Observational Usability - Non-Critical Tasks and IFU and training assessment
Time frame: 10.5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- M4 StudyLink provided by the sponsor.
- SPIRIT StudyLink provided by the sponsor.
- INSPIRE StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Jayaraman, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atalante in people with Hemiplegia, run by Wandercraft at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observational Usability - Critical Tasks (time frame: 10.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.