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Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)
Sponsor: Wandercraft
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2023-06-12
Completion Date
2026-02-28
Last Updated
2025-02-04
Healthy Volunteers
No
Conditions
Interventions
Use of the Atalante exoskeleton
Six weeks of exoskeleton sessions replacing conventional therapy sessions three times a week
Locations (5)
Hôpitaux Universitaires Henri Mondor APHP, site Albert Chenevier
Créteil, France
Centre de Médecine Physique et de Réadaptation APAJH de Pionsat
Pionsat, France
Schön Klinik
Bad Aibling, Germany
Vivantes Klinikum Spandau
Berlin, Germany
Institut Guttmann
Barcelona, Spain