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

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 Overview

• Status: Completed
• Conditions: Stroke; Stroke, Acute; Chronic Stroke; Stroke, Subacute
• Intervention / Treatment: Device: Use of the Atalante exoskeleton

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
• France
  • Berck, France, 62600
    • Centre Jacques Calvé - Fondation Hopale
  • Pionsat, France, 63330
    • Centre de Médecine Physique et de Réadaptation
  • Ploemeur, France, 56270
    • Centre mutualiste de Rééducation et de Réadaptation de Kerpape
  • Saint-Sébastien-de-Morsent, France, 20119
    • Hôpital La Musse, La Renaissance Sanitaire
• Luxembourg
  • Luxembourg, Luxembourg, 2674
    • Rehazenter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hemiplegia due to Cerebrovascular Accident (CVA)	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Throughout study completion, an average of 6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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")	At study start, day 1 and at study completion, up to 6 days
Evaluate the patient's gait speed without the Atalante exoskeleton	Evaluation of the gait speed measured without the Atalante exoskeleton in 10-Meter Walk Test (10MWT) at baseline and session 6	At study start, day 1 and at study completion, up to 6 days
Evaluate the patient's endurance without the Atalante exoskeleton	Evaluation of the covered distance without the Atalante exoskeleton measured in 6-Minute Walk Test (6MWT) at baseline and session 6	At study start, day 1 and at study completion, up to 6 days
Evaluate the patient's static and dynamic balance without the Atalante exoskeleton	Evaluation of static and dynamic balance without the Atalante exoskeleton measured with the Berg Balance Scale (BBS) at baseline and session 6 (0-20 on the BBS represents balance impairment; 21-40 on the BBS represents acceptable balance; 41-56 on the BBS represents good balance)	At study start, day 1 and at study completion, up to 6 days
Evaluate the patient's spasticity	Evaluation of the spasticity of the adductor muscles, hamstrings, quadriceps, and triceps surae measured with Modified Ashworth Scale at baseline and session 6 0 No increase in muscle tone; Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved; Considerable increase in muscle tone, passive movement difficult; Affected part(s) rigid in flexion or extension	At study start, day 1 and at study completion, up to 6 days
Evaluate the patient's pain	Evaluation of the pain measured before and after sessions 1 to 5 using the Visual Analogical Scale-Pain. The patient is asked to make pain ratings between "No Pain" and "Maximum pain imaginable", , with "No pain" corresponding on 0 on the caregiver side and and "Maximum pain imaginable" to 10 on caregiver side.	At study start, day 2 and at study completion, up to 6 days
Evaluate the patient's capability to stop the exoskeleton on time using the remote	Evaluation of the patient's capability to stop the exoskeleton, on time using the remote at session 5	At study mid term, up to 5 days
Evaluate the patient's satisfaction and perceptions upon completion of a locomotor training program with the Atalante exoskeleton	Evaluation of the satisfaction et perceptions via a questionnaire specific to the use of robotics exoskeleton at session 6. Questions are answered on a 7-level Likert scale.	At study completion, up to 6 days
Evaluate the use of the Atalante exoskeleton	Collection of data relating to the patient's walking parameters and level of assistance with the Atalante exoskeleton during sessions 1 to 5	At study start, day 2 and at study completion, up to 6 days
Evaluate the patient's skin condition to monitore the pressure points the patient may have with the contact of the exoskeleton.	The operator will perform a visual monitoring of the patient's skin to identify potential cutaneous morbidity at pressure points the patient may have with the exoskeleton before and after sessions 1 to 5.	At study start, day 2 and at study completion, up to 6 days
Evaluate the patient's level of anxiety and depression	Assessment of patient anxiety and depression by means of the Hospital Anxiety and Depression (HAD) scale at baseline and one week after the 5th session	At study start, day 1 and at one week afetr the study completion, up to 12 days

Collaborators and Investigators

• Sponsor: Wandercraft

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): March 28, 2022
• Study Completion (Actual): March 28, 2022

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: December 31, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Robotics; Physiotherapy; Walking; Exercises; Ambulation; Chronic stroke; Acute stroke; Powered exoskeleton; Subacute stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paralysis; Stroke; Hemiplegia
• Other Study ID Numbers: INSPIRE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No