NCT06107010 Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)
| NCT ID | NCT06107010 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wandercraft |
| Condition | Stroke, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2023-06-12 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2023-06-12 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * \>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. Exclusion Criteria: * 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) * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06107010 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06107010 currently recruiting?
Yes, NCT06107010 is actively recruiting participants. Contact the research team at rebecca.sauvagnac@wandercraft.health for enrollment information.
Where is the NCT06107010 trial being conducted?
This trial is being conducted at Créteil, France, Pionsat, France, Bad Aibling, Germany, Berlin, Germany and 1 additional location.
Who is sponsoring the NCT06107010 clinical trial?
NCT06107010 is sponsored by Wandercraft. The trial plans to enroll 66 participants.
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