Clinical trial NCT04694001: Evaluation of the Use of the Atalante Exoskeleton in Patients Presenting an Hemiplegia Due to Cerebrovascular Accident
Official title: Evaluation of the Use of the Atalante Exoskeleton in Patients Presenting an Hemiplegia Due to Cerebrovascular Accident
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Stroke, Acute
Stroke, Subacute
Chronic Stroke
Keywords: Robotics
Rehabilitation
Physiotherapy
Powered exoskeleton
Walking
Exercises
Ambulation
Stroke
Acute stroke
Subacute stroke
Chronic stroke
Lead sponsor: Wandercraft
Sponsor class: INDUSTRY
First posted: 2021-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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).


Eligibility criteria: 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.

Primary outcomes:
measure: The primary objective is to evaluate the incidence of treatment-emergent adverse events.
timeFrame: Throughout study completion, an average of 6 days
Secondary outcomes:
measure: Evaluate the patient's ability to walk without the Atalante exoskeleton
timeFrame: At study start, day 1 and at study completion, up to 6 days
measure: Evaluate the patient's gait speed without the Atalante exoskeleton
timeFrame: At study start, day 1 and at study completion, up to 6 days
measure: Evaluate the patient's endurance without the Atalante exoskeleton
timeFrame: At study start, day 1 and at study completion, up to 6 days
measure: Evaluate the patient's static and dynamic balance without the Atalante exoskeleton
timeFrame: At study start, day 1 and at study completion, up to 6 days
measure: Evaluate the patient's spasticity
timeFrame: At study start, day 1 and at study completion, up to 6 days
measure: Evaluate the patient's pain
timeFrame: At study start, day 2 and at study completion, up to 6 days
measure: Evaluate the patient's capability to stop the exoskeleton on time using the remote
timeFrame: At study mid term, up to 5 days
measure: Evaluate the patient's satisfaction and perceptions upon completion of a locomotor training program with the Atalante exoskeleton
timeFrame: At study completion, up to 6 days
measure: Evaluate the use of the Atalante exoskeleton
timeFrame: At study start, day 2 and at study completion, up to 6 days
measure: Evaluate the patient's skin condition to monitore the pressure points the patient may have with the contact of the exoskeleton.
timeFrame: At study start, day 2 and at study completion, up to 6 days
measure: Evaluate the patient's level of anxiety and depression
timeFrame: At study start, day 1 and at one week afetr the study completion, up to 12 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint-Luc
city: Berck
country: France
facility: Centre Jacques Calvé - Fondation Hopale
city: Pionsat
country: France
facility: Centre de Médecine Physique et de Réadaptation
city: Ploemeur
country: France
facility: Centre mutualiste de Rééducation et de Réadaptation de Kerpape
city: Saint-Sébastien-de-Morsent
country: France
facility: Hôpital La Musse, La Renaissance Sanitaire
city: Luxembourg
country: Luxembourg
facility: Rehazenter
Study officials:
References: