Evaluation of the Use of the Atalante Exoskeleton in Patients Presenting an Hemiplegia Due to Cerebrovascular Accident

Wandercraft40 enrolled

Overview

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 exoskeleton system in patients presenting an hemiplegia due to cerebrovascular accident. The primary endpoint is defined by the reported adverse events. The study will include 40 patients and takes place in six rehabilitation centers (4 in France, 1 in Luxembourg, 1 in Belgium).

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Stroke Stroke, Acute Stroke, Subacute Chronic Stroke

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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.

Outcomes

Primary Outcomes

The primary objective is to evaluate the incidence of treatment-emergent adverse events.

The primary endpoint is measured through reported Adverse Events (AEs) including adverse events (AEs), adverse device effects (ADEs), serious adverse events (SAEs), serious adverse device effects (SADEs), adverse procedure effects (APE), and new findings (NFs).

Time frame: Throughout study completion, an average of 6 days

Secondary Outcomes

Evaluate the patient's ability to walk without the Atalante exoskeleton

Evaluation of the walk performance with the Functional Ambulation Category (FAC) at baseline and session 6 (from 0 to 5, 0 being "patient cannot walk" and 5 "patient can walk independently anywhere")