Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)

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.

NCT Number	NCT06107010
Lead Sponsor	Wandercraft
Conditions	Stroke, Acute, Stroke, Ischemic, Stroke, Subacute, Stroke Hemorrhagic, Cerebrovascular Disorders, Cerebrovascular Accident, Hemiparesis, Hemiparesis;Poststroke/CVA +1 more
Enrollment	66 participants
Start Date	2023-06-12
Primary Completion	2026-02-28 (estimated)
Study Completion	2026-02-28 (estimated)
Updated on ClinicalTrials.gov	2025-02-04