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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemiplegia due to Cerebrovascular Accident (CVA) | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of the Atalante exoskeleton | Device | A session includes stand-up, walks, exercises with or without the assistance of the exoskeleton, rotation, side and back step, squat and sitting. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc | Brussels | 1200 | Belgium | |||
| Centre Jacques Calvé - Fondation Hopale |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40221748 | Derived | Lejeune T, Nuic D, Dehem S, Previnaire JG, Cuenot C, Debugne T, Kaps J, Paul B, Pean V, Perez SS, Juhel F, Tatsidou S, Kerdraon J. Hands-free Atalante exoskeleton in post-stroke gait and balance rehabilitation: a safety study. J Neuroeng Rehabil. 2025 Apr 12;22(1):82. doi: 10.1186/s12984-025-01621-z. |
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| 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
| 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 |
| Berck |
| 62600 |
| France |
| Centre de Médecine Physique et de Réadaptation | Pionsat | 63330 | France |
| Centre mutualiste de Rééducation et de Réadaptation de Kerpape | Ploemeur | 56270 | France |
| Hôpital La Musse, La Renaissance Sanitaire | Saint-Sébastien-de-Morsent | 20119 | France |
| Rehazenter | Luxembourg | 2674 | Luxembourg |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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