Using the Atalante exoskeleton to help stroke patients walk again
Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)
This study is testing if using the Atalante exoskeleton can help stroke patients walk better compared to regular therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wandercraft Industry-sponsored |
| Locations | 5 sites (Créteil and 4 other locations) |
| Trial ID | NCT06107010 on ClinicalTrials.gov |
What this trial studies
This clinical investigation, known as EarlyExo, is an international, multicentric, prospective, single-blinded randomized controlled trial aimed at assessing the effectiveness of the Atalante exoskeleton in improving walking recovery in hemiparetic patients who have limited mobility due to stroke. Participants will be divided into two groups: one receiving intensive walking sessions with the exoskeleton and the other receiving conventional therapy. The study will measure the proportion of patients achieving a higher functional ambulation category score after six weeks of intervention. The goal is to determine if the exoskeleton-assisted therapy leads to better functional outcomes compared to standard rehabilitation methods.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are in the acute to subacute phase of stroke recovery with a functional ambulation category score of less than 2.
Not a fit: Patients with muscle overactivity or significant joint pain that interferes with exoskeleton use may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance walking recovery in stroke patients with limited mobility.
How similar studies have performed: Other studies have shown promise in using robotic exoskeletons for rehabilitation, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Créteil and 4 other locations
- Hôpitaux Universitaires Henri Mondor APHP, site Albert Chenevier — Créteil, France (Recruiting)
- Centre de Médecine Physique et de Réadaptation APAJH de Pionsat — Pionsat, France (Recruiting)
- Schön Klinik — Bad Aibling, Germany (Not_yet_recruiting)
- Vivantes Klinikum Spandau — Berlin, Germany (Recruiting)
- Institut Guttmann — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Dr Rebecca Sauvagnac, MD
- Email: rebecca.sauvagnac@wandercraft.health
- Phone: (0)179353109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.