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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2022-03-28

Brief Summary

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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).

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Detailed Description

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Conditions

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Stroke Stroke, Acute Stroke, Subacute Chronic Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Hemiplegia due to Cerebrovascular Accident (CVA)

Group Type OTHER

Use of the Atalante exoskeleton

Intervention Type DEVICE

A session includes stand-up, walks, exercises with or without the assistance of the exoskeleton, rotation, side and back step, squat and sitting.

Interventions

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Use of the Atalante exoskeleton

A session includes stand-up, walks, exercises with or without the assistance of the exoskeleton, rotation, side and back step, squat and sitting.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No