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

Walking recovery expressed by the proportion of patients reaching a FAC score of 4 or higher at six months post stroke, assessed without the exoskeleton.

Time frame: 6 months post stroke

Time to reach FAC score of 4 or higher

Time frame: Day 1 (± 3 days), week 2 (± 3 days) and week 4 (± 3 days) after the beginning of the intervention period, end of the intervention period (Week 6 ± 3 days), discharge from hospital and 6 months post stroke (± 6 days).

Change in walking speed measured with the 10 Meter Walk Test (10MWT)

The 10MWT is used to assess gait speed in meters/second over a short distance. Two tests are successively administered, barefoot, at comfortable then at maximal walking speed without walking aids. If a patient is unable to ambulate at all, a score of 0 m/s is documented.

Time frame: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)

Changes in static and dynamic balance measured by the Berg Balance Scale (BBS)

The BBS is a subjective, ordinal scale that assesses the ability to safely balance and avoid falls, during a series of functional tasks. It is thus also a measure of the amount of assistance needed to perform these tasks safely. In most items, the subject must maintain a given position for a specified time or complete moving tasks of varying difficulty. Subject receives a score from 0-4 at each of the 14 items on the ability to meet these balance dimensions.

Time frame: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)

Change in transfer time from wheelchair to toilet and back to wheelchair

The purpose is to record the time needed by the patient to do the transfer wheelchair /toilet seat/ wheelchair. Reduction of this time could mean an improvement of independence in daily life for stroke patients for whom transferring to the toilet is a common difficulty.

Time frame: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)

Changes in maximal clinical muscle extensibility XV1 and maximal range of active motion XA against the resistance of the key lower limb muscles using the Five Step Assessment

Measurements of XV1 and XA for soleus, gastrocnemius, gluteus maximus, hamstrings, vastus and rectus femoris muscles, using to the Five Step Assessment * XV1 is the angle of arrest at slow speed of stretch, corresponding to the passive range of motion against the resistance of the tested muscle. * XA is the maximal active range of motion against the resistance of the evaluated antagonist muscle.

Time frame: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)

Changes in anxiety and depression scores using the Hospital and Depression scale (HAD)

The HAD is a two-dimension self-administered questionnaire developed to identify depression and anxiety among physically ill patients. Identifying these disorders and the context in which they develop is interesting as motivation of the patient seems to have an important impact on his progression. It consists of 14 items rated with a score from 0-4, divided into 7 items for anxiety and 7 items for depression based on the concept of anhedonia.

Time frame: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)

Changes in perceived quality of life assessed by the Short Form-36 (SF-36)

The SF-36 is a self-administered questionnaire that provides an evaluation of the generic Quality of Life. The version used is the RAND-36 Item Health Survey. There are 36 items (or questions) divided into eight domains: Physical component: 1. Physical functioning 2. Role limitations due to physical problems 3. Bodily pain 4. General health perceptions Mental component: 5. Social functioning 6. General mental health 7. Role limitations due to emotional problems 8. Vitality Each item is answered by the subject with a Likert scale.

Time frame: Day 1 (± 3 days) and 6 months post stroke (± 6 days)

Subject and Therapist satisfaction and willingness to continue training sessions

The subject is asked to answer two questions regarding his satisfaction and willingness to continue training sessions. The therapist answers one question on his satisfaction. The score of each question is evaluated with a 5-level Likert scale.

Time frame: End of Week 1 (± 3 days), end of Week 3 (± 3 days) and end of the intervention period (Week 6 ± 3 days)

Perceived workload by the therapists conducting sessions assessed with the NASA Task Load Index

The NASA Task Load Index is a multidimensional, subjective scale that rates perceived workload in order to assess a task.There are six items, answered by the therapists after the therapy session: 1. Mental demand 2. Physical demand 3. Temporal demand 4. Effort 5. Performance 6. Frustration level The therapist gives his answers for the task "conducting a therapy session with the Atalante device" for patients of the Exo group, and for the task "conducting a conventional therapy session" for patients of the Control group.

Time frame: End of Week 1 (± 3 days) and end of the intervention period (Week 6 ± 3 days)