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RECRUITING
NCT06107010
NA

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

View on ClinicalTrials.gov

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

Interventions

DEVICE

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