Use of the Atalante exoskeleton: Six weeks of exoskeleton sessions replacing conventional therapy sessions three times a week
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* \>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
* Patient with health insurance
* Informed and willing to sign an informed consent form approved by the Ethics Committee. For clarity, if a motor impairment prevents the subject from signing by himself, he/she can still be included if the signature can be done by an impartial witness.
Exclusion Criteria:
* 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
* Medical contra-indication to medium intensity physical strain
* Orthostatic hypotension (loss of \> 20 mmHg systolic BP after 3 minutes in standing position)
* Uncontrolled seizures
* Morphological contra-indications to the use of Atalante (as per user's manual)
* Pregnant woman
* Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention
* Concurrent participation in another interventional trial
Primary outcome measure(s)
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. — End of the intervention period (week 6) 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).
Trial sites (5)
Facility
City
Region
Status
Hôpitaux Universitaires Henri Mondor APHP, site Albert Chenevier
Créteil
France
Recruiting
Centre de Médecine Physique et de Réadaptation APAJH de Pionsat
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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