StrokeINSPIRENCT04694001
Evaluation of the Use of the Atalante Exoskeleton in Patients Presenting an Hemiplegia Due to Cerebrovascular Accident
A study testing Use of the Atalante exoskeleton in people with Stroke and Stroke, Acute, run by Wandercraft at 6 sites in 3 countries.
Trial summary
The INSPIRE study is interventional, European, prospective, open, multicentric, each patient being his/her own control. It is conducted to assess the safety and performance of the Atalante exoskeleton system in patients presenting an hemiplegia due to cerebrovascular accident. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke, Acute, Stroke, Subacute
- What is being tested?
- Use of the Atalante exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 12 Apr 2021to 28 Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with hemiplegia due to cerebrovascular accident, occurred two weeks ago or more, follow up in a rehabilitation center or in a hospital (inpatient or outpatient),
- Patient presenting a FAC score of 0, 1, 2 or 3,
- Patient whose etiological evaluation of the stroke has been complete,
- Adult patient ≥18 years old,
- Patient able to read and write in at least one of the languages of the country and who have signed an informed consent form.
Who cannot join
- Individuals with severe spasticity of adductor muscles, hamstring, quadriceps and triceps surae. Severe spasticity is defined by a score greater than 3 on the modified Ashworth scale,
- Pregnant women
- Individuals with history of osteoporotic fracture and pathology or treatment causing secondary osteoporosis,
- Pressure Ulcer of Grade I or higher according to the National Pressure Ulcer Advisory Panel (NPUAP) International Pressure Ulcer Classification System- European Pressure Ulcer Advisory Panel (EPUAP), in areas of contact with the Atalante system,
- Severe aphasia limiting ability to express needs or to fulfil questionnaires, at the discretion of the physician.
- Patient with a cardiac or respiratory contraindication to physical exertion,
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- Patient with a score below 18 on the Mini Mental State test,
- Patient unable to deliver his/her consent,
- Patient under legal protection,
- Patient participating at the same time in another study,
- Patients with morphological contraindications to the use of the Atalante exoskeleton.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
France4 sites
Centre Jacques Calvé - Fondation Hopale
Berck, 62600
Centre de Médecine Physique et de Réadaptation
Pionsat, 63330
Centre mutualiste de Rééducation et de Réadaptation de Kerpape
Ploemeur, 56270
Hôpital La Musse, La Renaissance Sanitaire
Saint-Sébastien-de-Morsent, 20119
About this study
The INSPIRE study is interventional, European, prospective, open, multicentric, each patient being his/her own control.
It is conducted to assess the safety and performance of the Atalante exoskeleton system in patients presenting an hemiplegia due to cerebrovascular accident. The primary endpoint is defined by the reported adverse events.
The study will include 40 patients and takes place in six rehabilitation centers (4 in France, 1 in Luxembourg, 1 in Belgium).
- Conditions
- Stroke, Stroke, Acute, Stroke, Subacute, Chronic Stroke
- Being tested
- Use of the Atalante exoskeleton
- Keywords
- Robotics, Rehabilitation, Physiotherapy, Powered exoskeleton, Walking, Exercises, Ambulation, Stroke, Acute stroke, Subacute stroke, Chronic stroke
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the Atalante exoskeletonDevice
A session includes stand-up, walks, exercises with or without the assistance of the exoskeleton, rotation, side and back step, squat and sitting.
| Study group | Role | What they receive |
|---|---|---|
| Hemiplegia due to Cerebrovascular Accident (CVA) | Other | Not described Receives: Device: Use of the Atalante exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to evaluate the incidence of treatment-emergent adverse events.
The primary endpoint is measured through reported Adverse Events (AEs) including adverse events (AEs), adverse device effects (ADEs), serious adverse events (SAEs), serious adverse device effects (SADEs), adverse procedure effects (APE), and new findings (NFs).
Measured: Throughout study completion, an average of 6 days
Secondary outcomes (11)
Evaluate the patient's ability to walk without the Atalante exoskeleton
Evaluation of the walk performance with the Functional Ambulation Category (FAC) at baseline and session 6 (from 0 to 5, 0 being "patient cannot walk" and 5 "patient can walk independently anywhere")
Measured: At study start, day 1 and at study completion, up to 6 days
Evaluate the patient's gait speed without the Atalante exoskeleton
Evaluation of the gait speed measured without the Atalante exoskeleton in 10-Meter Walk Test (10MWT) at baseline and session 6
Measured: At study start, day 1 and at study completion, up to 6 days
Evaluate the patient's endurance without the Atalante exoskeleton
Evaluation of the covered distance without the Atalante exoskeleton measured in 6-Minute Walk Test (6MWT) at baseline and session 6
Measured: At study start, day 1 and at study completion, up to 6 days
Evaluate the patient's static and dynamic balance without the Atalante exoskeleton
Evaluation of static and dynamic balance without the Atalante exoskeleton measured with the Berg Balance Scale (BBS) at baseline and session 6 (0-20 on the BBS represents balance impairment; 21-40 on the BBS represents acceptable balance; 41-56 on the BBS represents good balance)
Measured: At study start, day 1 and at study completion, up to 6 days
Evaluate the patient's spasticity
Evaluation of the spasticity of the adductor muscles, hamstrings, quadriceps, and triceps surae measured with Modified Ashworth Scale at baseline and session 6
0 No increase in muscle tone
- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
- More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
- Considerable increase in muscle tone, passive movement difficult
- Affected part(s) rigid in flexion or extension
Measured: At study start, day 1 and at study completion, up to 6 days
Evaluate the patient's pain
Evaluation of the pain measured before and after sessions 1 to 5 using the Visual Analogical Scale-Pain.
The patient is asked to make pain ratings between "No Pain" and "Maximum pain imaginable", , with "No pain" corresponding on 0 on the caregiver side and and "Maximum pain imaginable" to 10 on caregiver side.
Measured: At study start, day 2 and at study completion, up to 6 days
Evaluate the patient's capability to stop the exoskeleton on time using the remote
Evaluation of the patient's capability to stop the exoskeleton, on time using the remote at session 5
Measured: At study mid term, up to 5 days
Evaluate the patient's satisfaction and perceptions upon completion of a locomotor training program with the Atalante exoskeleton
Evaluation of the satisfaction et perceptions via a questionnaire specific to the use of robotics exoskeleton at session 6.
Questions are answered on a 7-level Likert scale.
Measured: At study completion, up to 6 days
Evaluate the use of the Atalante exoskeleton
Collection of data relating to the patient's walking parameters and level of assistance with the Atalante exoskeleton during sessions 1 to 5
Measured: At study start, day 2 and at study completion, up to 6 days
Evaluate the patient's skin condition to monitore the pressure points the patient may have with the contact of the exoskeleton.
The operator will perform a visual monitoring of the patient's skin to identify potential cutaneous morbidity at pressure points the patient may have with the exoskeleton before and after sessions 1 to 5.
Measured: At study start, day 2 and at study completion, up to 6 days
Evaluate the patient's level of anxiety and depression
Assessment of patient anxiety and depression by means of the Hospital Anxiety and Depression (HAD) scale at baseline and one week after the 5th session
Measured: At study start, day 1 and at one week afetr the study completion, up to 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start12 Apr 2021
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wandercraft
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694001
- Sponsor's protocol ID
- INSPIRE
- Acronym
- INSPIRE
- Status last verified
- Apr 2022
- First submitted
- 28 Dec 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lejeune T, Nuic D, Dehem S, Previnaire JG, Cuenot C, Debugne T, Kaps J, Paul B, Pean V, Perez SS, Juhel F, Tatsidou S, Kerdraon J. Hands-free Atalante exoskeleton in post-stroke gait and balance rehabilitation: a safety study. J Neuroeng Rehabil. 2025 Apr 12;22(1):82. doi: 10.1186/s12984-025-01621-z.
PubMed 40221748
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of the Atalante Exoskeleton in Patients Presenting an Hemiplegia Due to Cerebrovascular Accident
- ClinicalTrials.gov ID
- NCT04694001
- Acronym / sponsor ID
- INSPIRE / INSPIRE
- Conditions
- Stroke, Stroke, Acute, Stroke, Subacute, Chronic Stroke
- Keywords
- Robotics, Rehabilitation, Physiotherapy, Powered exoskeleton, Walking, Exercises, Ambulation, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- WandercraftIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 5 Jan 2021 (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 INSPIRE study is interventional, European, prospective, open, multicentric, each patient being his/her own control.
It is conducted to assess the safety and performance of the Atalante exoskeleton system in patients presenting an hemiplegia due to cerebrovascular accident. The primary endpoint is defined by the reported adverse events.
The study will include 40 patients and takes place in six rehabilitation centers (4 in France, 1 in Luxembourg, 1 in Belgium).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemiplegia due to Cerebrovascular Accident (CVA) | Other | Device: Use of the Atalante exoskeleton |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with hemiplegia due to cerebrovascular accident, occurred two weeks ago or more, follow up in a rehabilitation center or in a hospital (inpatient or outpatient),
- Patient presenting a FAC score of 0, 1, 2 or 3,
- Patient whose etiological evaluation of the stroke has been complete,
- Adult patient ≥18 years old,
- Patient able to read and write in at least one of the languages of the country and who have signed an informed consent form.
Key exclusion criteria (11 listed)
- Individuals with severe spasticity of adductor muscles, hamstring, quadriceps and triceps surae. Severe spasticity is defined by a score greater than 3 on the modified Ashworth scale,
- Pregnant women
- Individuals with history of osteoporotic fracture and pathology or treatment causing secondary osteoporosis,
- Pressure Ulcer of Grade I or higher according to the National Pressure Ulcer Advisory Panel (NPUAP) International Pressure Ulcer Classification System- European Pressure Ulcer Advisory Panel (EPUAP), in areas of contact with the Atalante system,
- Severe aphasia limiting ability to express needs or to fulfil questionnaires, at the discretion of the physician.
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 |
|---|---|---|
| Use of the Atalante exoskeletonA session includes stand-up, walks, exercises with or without the assistance of the exoskeleton, rotation, side and back step, squat and sitting. | Device | Hemiplegia due to Cerebrovascular Accident (CVA) |
Primary outcome
The primary objective is to evaluate the incidence of treatment-emergent adverse events.
Time frame: Throughout study completion, an average of 6 days
The primary endpoint is measured through reported Adverse Events (AEs) including adverse events (AEs), adverse device effects (ADEs), serious adverse events (SAEs), serious adverse device effects (SADEs), adverse procedure effects (APE), and new findings (NFs).
11 secondary outcomes
Evaluate the patient's ability to walk without the Atalante exoskeleton
Time frame: At study start, day 1 and at study completion, up to 6 days
Evaluate the patient's gait speed without the Atalante exoskeleton
Time frame: At study start, day 1 and at study completion, up to 6 days
Evaluate the patient's endurance without the Atalante exoskeleton
Time frame: At study start, day 1 and at study completion, up to 6 days
Evaluate the patient's static and dynamic balance without the Atalante exoskeleton
Time frame: At study start, day 1 and at study completion, up to 6 days
Evaluate the patient's spasticity
Time frame: At study start, day 1 and at study completion, up to 6 days
Evaluate the patient's pain
Time frame: At study start, day 2 and at study completion, up to 6 days
Evaluate the patient's capability to stop the exoskeleton on time using the remote
Time frame: At study mid term, up to 5 days
Evaluate the patient's satisfaction and perceptions upon completion of a locomotor training program with the Atalante exoskeleton
Time frame: At study completion, up to 6 days
Evaluate the use of the Atalante exoskeleton
Time frame: At study start, day 2 and at study completion, up to 6 days
Evaluate the patient's skin condition to monitore the pressure points the patient may have with the contact of the exoskeleton.
Time frame: At study start, day 2 and at study completion, up to 6 days
Evaluate the patient's level of anxiety and depression
Time frame: At study start, day 1 and at one week afetr the study completion, up to 12 days
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 27 Apr 2022.
- Derived from this study: PubMed 40221748Lejeune T, Nuic D, Dehem S, Previnaire JG, Cuenot C, Debugne T, Kaps J, Paul B, Pean V, Perez SS, Juhel F, Tatsidou S, Kerdraon J. Hands-free Atalante exoskeleton in post-stroke gait and balance rehabilitation: a safety study. J Neuroeng Rehabil. 2025 Apr 12;22(1):82. doi: 10.1186/s12984-025-01621-z.
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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.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the Atalante exoskeleton in people with Stroke and Stroke, Acute, run by Wandercraft at 6 sites in 3 countries.
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 5 inclusion and 11 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 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Belgium, Luxembourg. 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?
The primary objective is to evaluate the incidence of treatment-emergent adverse events. (time frame: Throughout study completion, an average of 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04694001, which also lists 1 linked publication.
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 27 Apr 2022.