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

Wandercraft

Status

Completed

Conditions

Stroke, Subacute

Stroke

Stroke, Acute

Chronic Stroke

Treatments

Device: Use of the Atalante exoskeleton

Study type

Interventional

Funder types

Industry

Identifiers

NCT04694001

INSPIRE

Details and patient eligibility

About

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).

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.