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.
>18 years old
First clinically significant disability due to stroke
Hemiparesis in acute-subacute phase (1 to 4 months since lesion) due to a stroke
Functional Ambulation Category score (FAC) <2
Muscle overactivity in hip adductors, hamstrings, quadriceps and plantar flexors, which interferes with exoskeleton use, based on clinician investigator's opinion
Recent fracture (< 3 months) or any therapy inducing secondary osteoporosis
Excessive joint mechanical pain in the lower limbs based on clinician investigator's opinion
Pressure sore grade I or more over contact zones with Atalante system, according to the International Pressure Ulcer Classification System NPUAP - EPUA
Parallel
Use of the Atalante exoskeleton
DeviceSix weeks of exoskeleton sessions replacing conventional therapy sessions three times a week
Walking recovery expressed by the proportion of patients reaching a Functional Ambulation Category (FAC) score of 4 or higher at the end of the intervention period, assessed without the exoskeleton.
The FAC is a 6-item ordinal scale that classifies the level of support needed to walk safely, irrespective of the use of a lower extremity orthosis or walking aid, ranging from 0 (unable to walk without the assistance of two people) to 5 (independent walking on uneven surfaces and on stairs).
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 to reach FAC score of 4 or higher
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.
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.
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