Stroke, AcuteEarlyExoNCT06107010
Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)
A study testing Use of the Atalante exoskeleton in people with Stroke, Acute and Stroke, Ischemic, run by Wandercraft at 5 sites in 3 countries.
Trial summary
The present clinical investigation - EarlyExo, is an interventional, international, multicentric, prospective, single-blinded randomized controlled trial. This clinical investigation is designed to test the hypothesis that early and intense introduction of walking sessions assisted by the Atalante exoskeleton, in a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Stroke, Ischemic, 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
- 66 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 12 Jun 2023to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- >18 years old
- First clinically significant disability due to stroke
- Hemiparesis in acute-subacute phase (1 to 4 months since lesion) due to a stroke
- Functional Ambulation Category score (FAC) <2
- Patient with health insurance
- Informed and willing to sign an informed consent form approved by the Ethics Committee. For clarity, if a motor impairment prevents the subject from signing by himself, he/she can still be included if the signature can be done by an impartial witness.
Who cannot join
- Muscle overactivity in hip adductors, hamstrings, quadriceps and plantar flexors, which interferes with exoskeleton use, based on clinician investigator's opinion
- Recent fracture (< 3 months) or any therapy inducing secondary osteoporosis
- Excessive joint mechanical pain in the lower limbs based on clinician investigator's opinion
- Pressure sore grade I or more over contact zones with Atalante system, according to the International Pressure Ulcer Classification System NPUAP - EPUA
- Medical contra-indication to medium intensity physical strain
- Orthostatic hypotension (loss of > 20 mmHg systolic BP after 3 minutes in standing position)
Show all 11Show fewer
- Uncontrolled seizures
- Morphological contra-indications to the use of Atalante (as per user's manual)
- Pregnant woman
- Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention
- Concurrent participation in another interventional trial
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
France2 sites, 2 recruiting
- Recruiting
Hôpitaux Universitaires Henri Mondor APHP, site Albert Chenevier
Créteil
Pr Jean-Michel Gracies, MD, PhD, +33 1 49 81 30 61, jean-michel.gracies@aphp.fr
Dr Caroline Colas, MD, +33 1 49 81 30 61, caroline.gracies@aphp.fr
- Recruiting
Centre de Médecine Physique et de Réadaptation APAJH de Pionsat
Pionsat
Dr Charles Orange, MD, c.orange@apajh.asso.fr
Thierry Halluin, +33 4 73 85 34 59, t.halluin@apajh.asso.fr
Germany2 sites, 2 recruiting
- Not yet recruiting
Schön Klinik
Bad Aibling
Dr Friedemann Müller, MD, M.Sc., fmueller@schoen-klinik.de
Dr Friedemann Müller, MD, M.Sc.
- Recruiting
Vivantes Klinikum Spandau
Berlin
Dr Anatol Kivi, MD, anatol.kivi@vivantes.de
Dr Anatol Kivi, MD
Spain1 site, 1 recruiting
- Recruiting
Institut Guttmann
Barcelona
Dr Cristian Andres Figueroa Chacón, MD, cafigueroa@guttmann.com
Dr Cristian Andres Figueroa Chacón, MD
About this study
The present clinical investigation - EarlyExo, is an interventional, international, multicentric, prospective, single-blinded randomized controlled trial.
This clinical investigation is designed to test the hypothesis that early and intense introduction of walking sessions assisted by the Atalante exoskeleton, in a sample of hemiparetic patients with still non or poor ambulatory capacities (FAC 0 or 1) between one- and four-months post stroke, would result in a better recovery of functional walking compared to a control group only receiving conventional therapy. Improved recovery will be measured through the proportion of patients reaching a FAC score of 4 or higher at the end of the intervention period. The tested hypothesis is that this proportion will be higher in the Exo group.
Read more
The duration of the intervention period in both groups is 6 weeks.
- For the Exo group: 3 sessions per week (i.e., 18 one-hour sessions) with the Atalante device and 2 sessions per week (i.e., 12 one-hour sessions) of conventional therapy.
- For the Control group: 5 sessions per week of conventional therapy (i.e., 30 one-hour sessions).
The study will include 66 patients (33 in each arm) and takes place in two French centers, two German centers and one Spanish center.
- Conditions
- Stroke, Acute, Stroke, Ischemic, Stroke, Subacute, Stroke Hemorrhagic, Cerebrovascular Disorders, Cerebrovascular Accident
- Being tested
- Use of the Atalante exoskeleton
- Keywords
- Robotics, Rehabilitation, Powered Exoskeleton, Walking recovery, Stroke, Acute stroke, Subacute stroke, Functional Ambulation Category, Randomized controlled study
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke, Cerebrovascular Disorders, Paresis, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the Atalante exoskeletonDevice
Six weeks of exoskeleton sessions replacing conventional therapy sessions three times a week
| Study group | Role | What they receive |
|---|---|---|
| Exo group | Experimental | During the 6-week intervention period, the Exo group will complete 3 sessions per week (i.e., 18 one-hour sessions) with the Atalante device and 2 sessions per week (i.e., 12 one-hour sessions) of conventional therapy.
During sessions with the exoskeleton, the patient will perform ambulatory exercises with the device, with a gradual increase of intensity through the sessions.
Conventional therapy corresponds to physiotherapy as part of post stroke standard of care of the center (tasks such as lower and upper limb practice, walking in parallel bars, etc., but this list is not exhaustive and depends on the practice of the therapists/centers). Receives: Device: Use of the Atalante exoskeleton |
| Control group | No intervention | During the 6-week intervention period, the Control group will complete 5 sessions per week of conventional therapy (i.e., 30 one-hour sessions). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking recovery expressed by the proportion of patients reaching a Functional Ambulation Category (FAC) score of 4 or higher at the end of the intervention period, assessed without the exoskeleton.
The FAC is a 6-item ordinal scale that classifies the level of support needed to walk safely, irrespective of the use of a lower extremity orthosis or walking aid, ranging from 0 (unable to walk without the assistance of two people) to 5 (independent walking on uneven surfaces and on stairs).
Measured: End of the intervention period (week 6)
Secondary outcomes (10)
Walking recovery expressed by the proportion of patients reaching a FAC score of 4 or higher at six months post stroke, assessed without the exoskeleton.
Measured: 6 months post stroke
Time to reach FAC score of 4 or higher
Measured: Day 1 (± 3 days), week 2 (± 3 days) and week 4 (± 3 days) after the beginning of the intervention period, end of the intervention period (Week 6 ± 3 days), discharge from hospital and 6 months post stroke (± 6 days).
Change in walking speed measured with the 10 Meter Walk Test (10MWT)
The 10MWT is used to assess gait speed in meters/second over a short distance. Two tests are successively administered, barefoot, at comfortable then at maximal walking speed without walking aids. If a patient is unable to ambulate at all, a score of 0 m/s is documented.
Measured: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)
Changes in static and dynamic balance measured by the Berg Balance Scale (BBS)
The BBS is a subjective, ordinal scale that assesses the ability to safely balance and avoid falls, during a series of functional tasks. It is thus also a measure of the amount of assistance needed to perform these tasks safely. In most items, the subject must maintain a given position for a specified time or complete moving tasks of varying difficulty. Subject receives a score from 0-4 at each of the 14 items on the ability to meet these balance dimensions.
Measured: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)
Change in transfer time from wheelchair to toilet and back to wheelchair
The purpose is to record the time needed by the patient to do the transfer wheelchair /toilet seat/ wheelchair. Reduction of this time could mean an improvement of independence in daily life for stroke patients for whom transferring to the toilet is a common difficulty.
Measured: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)
Changes in maximal clinical muscle extensibility XV1 and maximal range of active motion XA against the resistance of the key lower limb muscles using the Five Step Assessment
Measurements of XV1 and XA for soleus, gastrocnemius, gluteus maximus, hamstrings, vastus and rectus femoris muscles, using to the Five Step Assessment
- XV1 is the angle of arrest at slow speed of stretch, corresponding to the passive range of motion against the resistance of the tested muscle.
- XA is the maximal active range of motion against the resistance of the evaluated antagonist muscle.
Measured: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)
Changes in anxiety and depression scores using the Hospital and Depression scale (HAD)
The HAD is a two-dimension self-administered questionnaire developed to identify depression and anxiety among physically ill patients. Identifying these disorders and the context in which they develop is interesting as motivation of the patient seems to have an important impact on his progression. It consists of 14 items rated with a score from 0-4, divided into 7 items for anxiety and 7 items for depression based on the concept of anhedonia.
Measured: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)
Changes in perceived quality of life assessed by the Short Form-36 (SF-36)
The SF-36 is a self-administered questionnaire that provides an evaluation of the generic Quality of Life. The version used is the RAND-36 Item Health Survey. There are 36 items (or questions) divided into eight domains:
Physical component:
- Physical functioning
- Role limitations due to physical problems
- Bodily pain
- General health perceptions Mental component:
- Social functioning
- General mental health
- Role limitations due to emotional problems
- Vitality Each item is answered by the subject with a Likert scale.
Measured: Day 1 (± 3 days) and 6 months post stroke (± 6 days)
Subject and Therapist satisfaction and willingness to continue training sessions
The subject is asked to answer two questions regarding his satisfaction and willingness to continue training sessions. The therapist answers one question on his satisfaction. The score of each question is evaluated with a 5-level Likert scale.
Measured: End of Week 1 (± 3 days), end of Week 3 (± 3 days) and end of the intervention period (Week 6 ± 3 days)
Perceived workload by the therapists conducting sessions assessed with the NASA Task Load Index
The NASA Task Load Index is a multidimensional, subjective scale that rates perceived workload in order to assess a task.There are six items, answered by the therapists after the therapy session:
- Mental demand
- Physical demand
- Temporal demand
- Effort
- Performance
- Frustration level The therapist gives his answers for the task "conducting a therapy session with the Atalante device" for patients of the Exo group, and for the task "conducting a conventional therapy session" for patients of the Control group.
Measured: End of Week 1 (± 3 days) and end of the intervention period (Week 6 ± 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start12 Jun 2023
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wandercraft
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107010
- Sponsor's protocol ID
- EarlyExo
- Acronym
- EarlyExo
- Status last verified
- Jan 2025
- First submitted
- 24 Oct 2023
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)
- ClinicalTrials.gov ID
- NCT06107010
- Acronym / sponsor ID
- EarlyExo / EarlyExo
- Conditions
- Stroke, Acute, Stroke, Ischemic, Stroke, Subacute, Stroke Hemorrhagic, Cerebrovascular Disorders, Cerebrovascular Accident
- Keywords
- Robotics, Rehabilitation, Powered Exoskeleton, Walking recovery, Stroke, Acute stroke, Subacute stroke, Functional Ambulation Category
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- WandercraftIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 30 Oct 2023 (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 present clinical investigation - EarlyExo, is an interventional, international, multicentric, prospective, single-blinded randomized controlled trial.
This clinical investigation is designed to test the hypothesis that early and intense introduction of walking sessions assisted by the Atalante exoskeleton, in a sample of hemiparetic patients with still non or poor ambulatory capacities (FAC 0 or 1) between one- and four-months post stroke, would result in a better recovery of functional walking compared to a control group only receiving conventional therapy. Improved recovery will be measured through the proportion of patients reaching a FAC score of 4 or higher at the end of the intervention period. The tested hypothesis is that this proportion will be higher in the Exo group.
The duration of the intervention period in both groups is 6 weeks.
- For the Exo group: 3 sessions per week (i.e., 18 one-hour sessions) with the Atalante device and 2 sessions per week (i.e., 12 one-hour sessions) of conventional therapy.
- For the Control group: 5 sessions per week of conventional therapy (i.e., 30 one-hour sessions).
The study will include 66 patients (33 in each arm) and takes place in two French centers, two German centers and one Spanish center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blind
| Arm | Type | Receives |
|---|---|---|
| Exo group | Experimental | Device: Use of the Atalante exoskeletonDuring the 6-week intervention period, the Exo group will complete 3 sessions per week (i.e., 18 one-hour sessions) with the Atalante device and 2 sessions per week (i.e., 12 one-hour sessions) of conventional therapy. During sessions with the exoskeleton, the patient will perform ambulatory exercises with the device, with a gradual increase of intensity through the sessions. Conventional therapy corresponds to physiotherapy as part of post stroke standard of care of the center (tasks such as lower and upper limb practice, walking in parallel bars, etc., but this list is not exhaustive and depends on the practice of the therapists/centers). |
| Control group | No intervention | –During the 6-week intervention period, the Control group will complete 5 sessions per week of conventional therapy (i.e., 30 one-hour sessions). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >18 years old
- First clinically significant disability due to stroke
- Hemiparesis in acute-subacute phase (1 to 4 months since lesion) due to a stroke
- Functional Ambulation Category score (FAC) <2
- Patient with health insurance
Key exclusion criteria (11 listed)
- Muscle overactivity in hip adductors, hamstrings, quadriceps and plantar flexors, which interferes with exoskeleton use, based on clinician investigator's opinion
- Recent fracture (< 3 months) or any therapy inducing secondary osteoporosis
- Excessive joint mechanical pain in the lower limbs based on clinician investigator's opinion
- Pressure sore grade I or more over contact zones with Atalante system, according to the International Pressure Ulcer Classification System NPUAP - EPUA
- Medical contra-indication to medium intensity physical strain
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 exoskeletonSix weeks of exoskeleton sessions replacing conventional therapy sessions three times a week | Device | Exo group |
Primary outcome
Walking recovery expressed by the proportion of patients reaching a Functional Ambulation Category (FAC) score of 4 or higher at the end of the intervention period, assessed without the exoskeleton.
Time frame: End of the intervention period (week 6)
The FAC is a 6-item ordinal scale that classifies the level of support needed to walk safely, irrespective of the use of a lower extremity orthosis or walking aid, ranging from 0 (unable to walk without the assistance of two people) to 5 (independent walking on uneven surfaces and on stairs).
10 secondary outcomes
Walking recovery expressed by the proportion of patients reaching a FAC score of 4 or higher at six months post stroke, assessed without the exoskeleton.
Time frame: 6 months post stroke
Time to reach FAC score of 4 or higher
Time frame: Day 1 (± 3 days), week 2 (± 3 days) and week 4 (± 3 days) after the beginning of the intervention period, end of the intervention period (Week 6 ± 3 days), discharge from hospital and 6 months post stroke (± 6 days).
Change in walking speed measured with the 10 Meter Walk Test (10MWT)
Time frame: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)
Changes in static and dynamic balance measured by the Berg Balance Scale (BBS)
Time frame: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)
Change in transfer time from wheelchair to toilet and back to wheelchair
Time frame: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)
Changes in maximal clinical muscle extensibility XV1 and maximal range of active motion XA against the resistance of the key lower limb muscles using the Five Step Assessment
Time frame: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)
Changes in anxiety and depression scores using the Hospital and Depression scale (HAD)
Time frame: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)
Changes in perceived quality of life assessed by the Short Form-36 (SF-36)
Time frame: Day 1 (± 3 days) and 6 months post stroke (± 6 days)
Subject and Therapist satisfaction and willingness to continue training sessions
Time frame: End of Week 1 (± 3 days), end of Week 3 (± 3 days) and end of the intervention period (Week 6 ± 3 days)
Perceived workload by the therapists conducting sessions assessed with the NASA Task Load Index
Time frame: End of Week 1 (± 3 days) and end of the intervention period (Week 6 ± 3 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 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.
5 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, Acute and Stroke, Ischemic, run by Wandercraft at 5 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 6 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: looking for participants now, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Germany, Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Rebecca Sauvagnac, MD ((0)179353109, rebecca.sauvagnac@wandercraft.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking recovery expressed by the proportion of patients reaching a Functional Ambulation Category (FAC) score of 4 or higher at the end of the intervention period, assessed without the exoskeleton. (time frame: End of the intervention period (week 6)). 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 Feb 2025.