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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Wandercraft · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke, Acute
• Stroke, Ischemic
• Stroke, Subacute
• Stroke Hemorrhagic
• Cerebrovascular Disorders
• Cerebrovascular Accident
• Hemiparesis
• Hemiparesis;Poststroke/CVA
• Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)

Interventions

Type	Name	Description
DEVICE	Use of the Atalante exoskeleton	Six weeks of exoskeleton sessions replacing conventional therapy sessions three times a week

Timeline

• Start date: 2023-06-12
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2023-10-30
• Last updated: 2025-02-04

Locations

5 sites across 3 countries: France, Germany, Spain