Spinal Cord InjuryQUATRONCT06939634
Evaluation of Usability and Safety of the System Atalante in Patients With High Paraplegia and Tetraplegia
An observational study of Spinal Cord Injury and Tetraplegia/Tetraparesis, run by Wandercraft at 3 sites in France.
Trial summary
The objective of this clinical trial is to determine whether the Atalante X exoskeleton can be safely utilized by patients with tetraplegia and high paraplegia (at or above T4). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Tetraplegia/Tetraparesis, Paraplegia, Complete
- What is being tested?
- Hands-free exoskeleton
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Jun 2024to 1 Sep 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The population includes people with high paraplegia and tetraplegia.
Who may be able to join
- ≥18 years old,
- Tetraplegia or high paraplegia (at or above T4) regardless of the cause,
- Non-opposition to the participation to the study,
- Having undergone a minimum of 1 session with the Atalante device from February 2019, to now.
Who cannot join
- Neurological Level of Injury below T4 as determined by the International Standards for Neurological Classification of SCI
Trial locations and contacts
3 sites in 1 country.
France3 sites
Fondation Hopale
Berck, France, 62600
CMPR de Pionsat
Pionsat, France, 63330
Hôpital La Musse
Saint-Sébastien-de-Morsent, France, 27180
About this study
The objective of this clinical trial is to determine whether the Atalante X exoskeleton can be safely utilized by patients with tetraplegia and high paraplegia (at or above T4).
- Conditions
- Spinal Cord Injury, Tetraplegia/Tetraparesis, Paraplegia, Complete, Paraplegia, Incomplete, Guillain Barré Syndrome
- Being tested
- Hands-free exoskeleton
- Keywords
- Hands-free Exoskeleton, Atalante X, Atalante, Rehabilitation, Safety
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia, Paraplegia, Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hands-free exoskeletonDevice
Having undergone at least on session with Atalante exoskeleton. Clinical, safety and session data are collected retrospectively.
| Study group | Role | What they receive |
|---|---|---|
| Hands-free exoskeleton | Patient with high paraplegia or tetraplegia who have undergone at least one session with the exoskeleton. Receives: Device: Hands-free exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety through the collection of the reported adverse device effects
Measured through all reported adverse device effects (ADEs). ADEs are categorized into the following categories: musculoskeletal, cutaneous (skin abrasion), cardiovascular (orthostatic hypotension), pain, falls, and fractures and are further characterized as minor or serious based on the nature and the severity of the adverse event (AE).
Measured: Baseline, up to 101 weeks.
Secondary outcomes (8)
Spasticity assessment
This may involve the use of the Modified Ashworth Scale or a general description of spasticity recorded in the medical file.
Measured: Baseline, post-intervention (up to 101 weeks)
Walking ability
This may involve Walking Index for Spinal Cord Injury, version II (WISCI II) assessing the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from SCI. It ranges from 0 (unable to stand and/or participate in assisted walking) to 20 (ambulates with no devices, no braces and no physical assistance, 10 meters).
Measured: Baseline, post-intervention (up to 101 weeks)
Walking speed
This may involve 10 meters walk test (10MWT) measuring gait speed during a 10-meter walk during comfortable and rapid pace.
Measured: Baseline, post-intervention (up to 101 weeks)
Mobility, balance, walking ability, and fall
This may involve Time Up and Go (TUG), a timed task where the patient is asked to stand up from the chair, walk 3 meters, turn around, walk and sit again.
Measured: Baseline, post-intervention (up to 101 weeks)
Endurance
This may involve 6-minutes' walk test (6MWT) and 2-minutes' walk test (2MWT) measuring the walked distance during a 6- or 2-minutes' walk.
Measured: Baseline, post-intervention (up to 101 weeks)
Balance
This may involve Berg Balance Scale (BBS) including items include static and dynamic activities of varying difficulty.
Measured: Baseline, post-intervention (up to 101 weeks)
Independance
This may involve Spinal Cord Independence Measure (SCIM III) including items assessing self-care, respiration and sphincter management.
Measured: Baseline, post-intervention (up to 101 weeks)
Usability assessment
The assessment of the usability will be asked to the operators in charge of the rehabilitation of the patients included in this study. It includes a usability questionnaire and session data collection.
Measured: Post-intervention (up to 101 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 Jun 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wandercraft
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939634
- Sponsor's protocol ID
- CIP009
- Acronym
- QUATRO
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Usability and Safety of the System Atalante in Patients With High Paraplegia and Tetraplegia
- ClinicalTrials.gov ID
- NCT06939634
- Acronym / sponsor ID
- QUATRO / CIP009
- Conditions
- Spinal Cord Injury, Tetraplegia/Tetraparesis, Paraplegia, Complete, Paraplegia, Incomplete, Guillain Barré Syndrome
- Keywords
- Hands-free Exoskeleton, Atalante X, Atalante, Rehabilitation, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- WandercraftIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 23 Apr 2025 (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 objective of this clinical trial is to determine whether the Atalante X exoskeleton can be safely utilized by patients with tetraplegia and high paraplegia (at or above T4).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hands-free exoskeleton | – | Device: Hands-free exoskeletonPatient with high paraplegia or tetraplegia who have undergone at least one session with the exoskeleton. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population includes people with high paraplegia and tetraplegia.
Key inclusion criteria (4 listed)
- ≥18 years old,
- Tetraplegia or high paraplegia (at or above T4) regardless of the cause,
- Non-opposition to the participation to the study,
- Having undergone a minimum of 1 session with the Atalante device from February 2019, to now.
Key exclusion criteria (1 listed)
- Neurological Level of Injury below T4 as determined by the International Standards for Neurological Classification of SCI
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 exoskeletonHaving undergone at least on session with Atalante exoskeleton. Clinical, safety and session data are collected retrospectively. | Device | Hands-free exoskeleton |
Primary outcome
Safety through the collection of the reported adverse device effects
Time frame: Baseline, up to 101 weeks.
Measured through all reported adverse device effects (ADEs). ADEs are categorized into the following categories: musculoskeletal, cutaneous (skin abrasion), cardiovascular (orthostatic hypotension), pain, falls, and fractures and are further characterized as minor or serious based on the nature and the severity of the adverse event (AE).
8 secondary outcomes
Spasticity assessment
Time frame: Baseline, post-intervention (up to 101 weeks)
Walking ability
Time frame: Baseline, post-intervention (up to 101 weeks)
Walking speed
Time frame: Baseline, post-intervention (up to 101 weeks)
Mobility, balance, walking ability, and fall
Time frame: Baseline, post-intervention (up to 101 weeks)
Endurance
Time frame: Baseline, post-intervention (up to 101 weeks)
Balance
Time frame: Baseline, post-intervention (up to 101 weeks)
Independance
Time frame: Baseline, post-intervention (up to 101 weeks)
Usability assessment
Time frame: Post-intervention (up to 101 weeks)
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 23 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury and Tetraplegia/Tetraparesis, run by Wandercraft at 3 sites in France.
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 4 inclusion and 1 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 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Safety through the collection of the reported adverse device effects (time frame: Baseline, up to 101 weeks.). 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 23 Apr 2025.