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

Study Overview
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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).

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

Conditions
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Stroke, Stroke, Acute, Stroke, Subacute, Chronic Stroke

Intervention / Treatment
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* Device: Use of the Atalante exoskeleton


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hemiplegia due to Cerebrovascular Accident (CVA)<br> | Device: Use of the Atalante exoskeleton<br>* A session includes stand-up, walks, exercises with or without the assistance of the exoskeleton, rotation, side and back step, squat and sitting.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Robotics, Rehabilitation, Physiotherapy, Powered exoskeleton, Walking, Exercises, Ambulation, Acute stroke, Subacute stroke, Chronic stroke