Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)
NCT ID: NCT06107010
Last Updated: 2025-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2023-06-12
2026-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Exo group
During the 6-week intervention period, the Exo group will complete 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.
During sessions with the exoskeleton, the patient will perform ambulatory exercises with the device, with a gradual increase of intensity through the sessions.
Conventional therapy corresponds to physiotherapy as part of post stroke standard of care of the center (tasks such as lower and upper limb practice, walking in parallel bars, etc., but this list is not exhaustive and depends on the practice of the therapists/centers).
Use of the Atalante exoskeleton
Six weeks of exoskeleton sessions replacing conventional therapy sessions three times a week
Control group
During the 6-week intervention period, the Control group will complete 5 sessions per week of conventional therapy (i.e., 30 one-hour sessions).
No interventions assigned to this group
Interventions
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Use of the Atalante exoskeleton
Six weeks of exoskeleton sessions replacing conventional therapy sessions three times a week
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Wandercraft
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EarlyExo
Identifier Type: -
Identifier Source: org_study_id
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