Spinal Cord InjuriesExoUserNCT06715631
Human Factors Validation Testing of the Wandercraft Personal Exoskeleton
A study testing Hands-free exoskeleton in people with Spinal Cord Injuries and Tetraplegia, run by Wandercraft at 1 site in France.
Trial summary
The goal of this interventional, national, prospective, open and monocentric study is to demonstrate that a personal exoskeleton 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
- Spinal Cord Injuries, Tetraplegia, Paraplegia
- What is being tested?
- Hands-free exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 20 Aug 2024to 31 Oct 2024
- 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
SCI user inclusion criteria:
- Any gender, age 18 years old or older.
- Motor complete or incomplete SCI with a clinical presentation of a neurological level at or above T6.
- Has been released from acute inpatient care following their SCI.
- Able and willing to attend 6 one-to-two-hour sessions of training.
- Able to read, understand, and provide informed consent.
- Patients affiliated to a social security system.
SCI user exclusion criteria:
- Any neurological injury other than spinal cord injury (SCI), except where such injury does not result in physical disability
- Progressive condition that would be expected to result in changing neurological status.
- Severe concurrent medical disease, illness or condition judged to be contraindicated by the site physician.
- Unhealed or unstable traumatic or high impact lower extremity fracture of any duration that is, in the clinical judgement of the study physician, exclusionary for standing and walking.
- Individual with history of osteoporotic fracture and / or pathology or treatment causing secondary osteoporosis.
- Untreatable severe spasticity judged to be contraindicated by the site physician.
- Untreated/uncontrolled hypertension as judged to be contraindicated by the site physician.
- Unresolved orthostatic hypotension as judged to be contraindicated by the site physician.
- History of uncontrolled autonomic dysreflexia.
- Presence of colostomy and/or urostomy.
- Ventilator use at the time of exoskeleton use.
- Presence of life supporting device (e.g., pacemaker).
- Open or unhealed skin pressure sores, abrasions, or bruises at any of the contact points of the exoskeleton.
- Morphological contraindications to the use of the device.
- Uncorrectable leg length discrepancy over 2 cm (about 0.79 in) when using additional correction tools.
- Individuals with functional and/or cognitive impairments that prevent them from effectively operating the device using a hand control interface.
- Improper fitting in the device.
- Psychopathology documentation in the medical record that may conflict with study objectives.
- Pregnancy or women who plan to become pregnant during the study period.
- Concurrent participation in another interventional trial.
- Patient under legal protection.
Companion inclusion criteria:
- Any gender, age 18 years or older.
- Able and willing to attend 6 one-to-two-hour sessions of training.
- Able to read, understand and provide informed consent.
Companion exclusion criteria:
- Inability to communicate with an assistant due to cognitive or language disorders.
- Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol- specified assessments.
- Insufficient strength and performance capability, evidenced by the ability to hold and retain the device in case of unbalance/fall.
- Presence of life supporting device (e.g., pacemaker).
- Concurrent participation in another interventional trial.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this interventional, national, prospective, open and monocentric study is to demonstrate that a personal exoskeleton 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
The Atalante X exoskeleton, Wandercraft's first-generation hands-free, self-balancing device covered by an EC certificate and cleared by the FDA, was primarily utilized in rehabilitation institutions. However, recognizing the potential benefits of self-balancing exoskeleton technology in home settings for individuals with paraplegia and tetraplegia, Wandercraft developed a personal exoskeleton designed for home and community use.
The scope of this protocol is to validate all the critical tasks performed by the intended SCI users and companions of the device, according to IEC 62366-1(2020) and the FDA Guidance "Applying human Factors and Usability Engineering to Medical Devices.
Up to 14 participants will be recruited and will include:
- SCI users: adult patients with motor complete or incomplete SCI with a clinical presentation of a neurological level at or above T6,
- Companions: adult individuals in charge of assisting the patient during the use of the device.
Both the SCI user and their companion must complete a joint certification program to ensure safe and effective use of the device. The program is provided by a Wandercraft certified trainer and consists of five sessions spread over a maximum period of two months. These sessions include both theoretical presentations on the exoskeleton and practical hands-on training. As a precautionary measure in this usability study, a safety rail will be used to secure the user but it will not be part of the final product.
Usability will be assessed by:
- IFU questionnaire,
- Simulated tasks test,
- Final debriefing.
- Conditions
- Spinal Cord Injuries, Tetraplegia, Paraplegia
- Being tested
- Hands-free exoskeleton
- Keywords
- Spinal Cord Injuries, Robotics, Community use, Hands-free exoskeleton, Overground exoskeleton, Walking, Self-balancing
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hands-free exoskeletonDevice
Before the simulated-use test, the SCI user and his/her companion must attend five training sessions provided by a Wandercraft certified trainer. Training will be composed by a theoretical part including presentation and description of the personal exoskeleton and its use modes and a hands-on practice. Each session lasts between 1 to 2 hours, varying according to the user's learning pace and tolerance. The training program is representative of the intended training for the end product.
| Study group | Role | What they receive |
|---|---|---|
| Hands-free exoskeleton | Experimental | Not described Receives: Device: Hands-free exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCI user and companion performance when carrying out tasks that are critical tasks
The acceptance criterion for this test is 100% of the trained SCI users and trained companions are able to perform each of the critical task successfully during a simulated-use test.
Measured: At session 6, after an average of 7.5 hours of training.
Secondary outcomes (4)
Use errors, close calls, and use difficulties
Collection of observed use errors, close calls, and use difficulties and identification of critical issues during a simulated-use test - no passing criteria.
Measured: At session 6, after an average of 7.5 hours of training.
SCI user and companion general performance when carrying non-critical tasks
The acceptance criterion for this test is 90% of the trained SCI users and trained companions are able to perform each of the non-critical task successfully during a simulated-use test.
Measured: At session 6, after an average of 7.5 hours of training.
Readability and clarity of Instructions for Use (IFU)
The acceptance criteria for this test is 100% of the SCI users and companions are able to answer to the critical task questions of the IFU questionnaire correctly and 90% are able to answer to the non-critical task questions correctly.
Measured: At session 5, after an average of 6 hours of training.
SCI user and companion opinion on the accompanying documents and training
The acceptance criterion for this test is 90% of the trained SCI users and trained companion rate the accompanying documents and training 3 or higher using 5-level Likert scale (1 inadequate, 2 barely adequate, 3 neither adequate nor inadequate, 4 adequate, 5 satisfactory).
Measured: At session 6, after an average of 7.5 hours of training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start20 Aug 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wandercraft
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Sauvagnac, MD, Principal investigator, Wandercraft
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715631
- Sponsor's protocol ID
- CIP010
- Acronym
- ExoUser
- Status last verified
- Dec 2024
- First submitted
- 18 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Factors Validation Testing of the Wandercraft Personal Exoskeleton
- ClinicalTrials.gov ID
- NCT06715631
- Acronym / sponsor ID
- ExoUser / CIP010
- Conditions
- Spinal Cord Injuries, Tetraplegia, Paraplegia
- Keywords
- Spinal Cord Injuries, Robotics, Community use, Hands-free exoskeleton, Overground exoskeleton, Walking, Self-balancing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- WandercraftIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 4 Dec 2024 (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 goal of this interventional, national, prospective, open and monocentric study is to demonstrate that a personal exoskeleton 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
The Atalante X exoskeleton, Wandercraft's first-generation hands-free, self-balancing device covered by an EC certificate and cleared by the FDA, was primarily utilized in rehabilitation institutions. However, recognizing the potential benefits of self-balancing exoskeleton technology in home settings for individuals with paraplegia and tetraplegia, Wandercraft developed a personal exoskeleton designed for home and community use.
The scope of this protocol is to validate all the critical tasks performed by the intended SCI users and companions of the device, according to IEC 62366-1(2020) and the FDA Guidance "Applying human Factors and Usability Engineering to Medical Devices.
Up to 14 participants will be recruited and will include:
- SCI users: adult patients with motor complete or incomplete SCI with a clinical presentation of a neurological level at or above T6,
- Companions: adult individuals in charge of assisting the patient during the use of the device.
Both the SCI user and their companion must complete a joint certification program to ensure safe and effective use of the device. The program is provided by a Wandercraft certified trainer and consists of five sessions spread over a maximum period of two months. These sessions include both theoretical presentations on the exoskeleton and practical hands-on training. As a precautionary measure in this usability study, a safety rail will be used to secure the user but it will not be part of the final product.
Usability will be assessed by:
- IFU questionnaire,
- Simulated tasks test,
- Final debriefing.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hands-free exoskeleton | Experimental | Device: Hands-free exoskeleton |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Hands-free exoskeletonBefore the simulated-use test, the SCI user and his/her companion must attend five training sessions provided by a Wandercraft certified trainer. Training will be composed by a theoretical part including presentation and description of the personal exoskeleton and its use modes and a hands-on practice. Each session lasts between 1 to 2 hours, varying according to the user's learning pace and tolerance. The training program is representative of the intended training for the end product. | Device | Hands-free exoskeleton |
Primary outcome
SCI user and companion performance when carrying out tasks that are critical tasks
Time frame: At session 6, after an average of 7.5 hours of training.
The acceptance criterion for this test is 100% of the trained SCI users and trained companions are able to perform each of the critical task successfully during a simulated-use test.
4 secondary outcomes
Use errors, close calls, and use difficulties
Time frame: At session 6, after an average of 7.5 hours of training.
SCI user and companion general performance when carrying non-critical tasks
Time frame: At session 6, after an average of 7.5 hours of training.
Readability and clarity of Instructions for Use (IFU)
Time frame: At session 5, after an average of 6 hours of training.
SCI user and companion opinion on the accompanying documents and training
Time frame: At session 6, after an average of 7.5 hours of training.
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 4 Dec 2024.
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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.
Rebecca Sauvagnac, MD principal investigator
Wandercraft
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hands-free exoskeleton in people with Spinal Cord Injuries and Tetraplegia, run by Wandercraft at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Dec 2024. 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 France. 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?
SCI user and companion performance when carrying out tasks that are critical tasks (time frame: At session 6, after an average of 7.5 hours of training.). 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 4 Dec 2024.