Status:
RECRUITING
Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)
Lead Sponsor:
Wandercraft
Conditions:
Stroke, Acute
Stroke, Ischemic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The present clinical investigation - EarlyExo, is an interventional, international, multicentric, prospective, single-blinded randomized controlled trial. This clinical investigation is designed to t...
Eligibility Criteria
Inclusion
- \>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
- 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
Key Trial Info
Start Date :
June 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06107010
Start Date
June 12 2023
End Date
February 28 2026
Last Update
February 4 2025
Active Locations (5)
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1
Hôpitaux Universitaires Henri Mondor APHP, site Albert Chenevier
Créteil, France
2
Centre de Médecine Physique et de Réadaptation APAJH de Pionsat
Pionsat, France
3
Schön Klinik
Bad Aibling, Germany
4
Vivantes Klinikum Spandau
Berlin, Germany