Status:
COMPLETED
Evaluation of the Use of the Atalante Exoskeleton in Patients Presenting an Hemiplegia Due to Cerebrovascular Accident
Lead Sponsor:
Wandercraft
Conditions:
Stroke
Stroke, Acute
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The INSPIRE study is interventional, European, prospective, open, multicentric, each patient being his/her own control. It is conducted to assess the safety and performance of the Atalante exoskeleto...
Eligibility Criteria
Inclusion
- Patient with hemiplegia due to cerebrovascular accident, occurred two weeks ago or more, follow up in a rehabilitation center or in a hospital (inpatient or outpatient),
- Patient presenting a FAC score of 0, 1, 2 or 3,
- Patient whose etiological evaluation of the stroke has been complete,
- Adult patient ≥18 years old,
- Patient able to read and write in at least one of the languages of the country and who have signed an informed consent form.
Exclusion
- Individuals with severe spasticity of adductor muscles, hamstring, quadriceps and triceps surae. Severe spasticity is defined by a score greater than 3 on the modified Ashworth scale,
- Pregnant women
- Individuals with history of osteoporotic fracture and pathology or treatment causing secondary osteoporosis,
- Pressure Ulcer of Grade I or higher according to the National Pressure Ulcer Advisory Panel (NPUAP) International Pressure Ulcer Classification System- European Pressure Ulcer Advisory Panel (EPUAP), in areas of contact with the Atalante system,
- Severe aphasia limiting ability to express needs or to fulfil questionnaires, at the discretion of the physician.
- Patient with a cardiac or respiratory contraindication to physical exertion,
- Patient with a score below 18 on the Mini Mental State test,
- Patient unable to deliver his/her consent,
- Patient under legal protection,
- Patient participating at the same time in another study,
- Patients with morphological contraindications to the use of the Atalante exoskeleton.
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04694001
Start Date
April 12 2021
End Date
March 28 2022
Last Update
April 27 2022
Active Locations (6)
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1
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
2
Centre Jacques Calvé - Fondation Hopale
Berck, France, 62600
3
Centre de Médecine Physique et de Réadaptation
Pionsat, France, 63330
4
Centre mutualiste de Rééducation et de Réadaptation de Kerpape
Ploemeur, France, 56270