Study on the Effects of Atalante Exoskeleton Therapy for Improving Walking in Adults With Hemiparesis After Stroke 1 to 4 Months Post-Stroke

What this Trial Is About

Researchers are evaluating the effects of early and intense walking sessions assisted by the Atalante exoskeleton in patients with hemiparesis who have poor or no ability to walk Functional Ambulation Category score of 0 or 1 between one and four months after a stroke. This trial compares the recovery of walking ability between patients using the exoskeleton plus conventional therapy and those receiving only conventional therapy. The goal is to see if more patients reach a walking ability score of 4 or higher after the intervention period. Participants are divided into two groups for a 6-week intervention. The Exo group will have three one-hour sessions per week using the Atalante exoskeleton combined with two conventional therapy sessions weekly, totaling 18 exoskeleton and 12 conventional sessions. The Control group will receive five conventional therapy sessions per week, totaling 30 one-hour sessions. Conventional therapy includes physiotherapy tasks such as limb practice and walking exercises. During the study, participants will be assessed on walking recovery without the exoskeleton, using measures like the Functional Ambulation Category score, walking speed, balance tests, muscle flexibility, and quality of life questionnaires. These assessments occur at multiple timepoints including the start, end of intervention, hospital discharge, and six months post-stroke. Researchers will also monitor anxiety, depression, patient and therapist satisfaction, and workload during sessions. The total study duration includes the 6-week intervention and follow-ups extending to six months.

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