- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04694001
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bruxelles, Belgium, 1200
- Cliniques Universitaires Saint-Luc
-
-
-
-
-
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, 2674
- Rehazenter
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Hemiplegia due to Cerebrovascular Accident (CVA)
|
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.
Time Frame: Throughout study completion, an average of 6 days
|
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
Time Frame: At study start, day 1 and at study completion, up to 6 days
|
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
Time Frame: At study start, day 1 and at study completion, up to 6 days
|
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
Time Frame: At study start, day 1 and at study completion, up to 6 days
|
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
Time Frame: At study start, day 1 and at study completion, up to 6 days
|
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
Time Frame: At study start, day 1 and at study completion, up to 6 days
|
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
Time Frame: At study start, day 2 and at study completion, up to 6 days
|
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
Time Frame: At study mid term, up to 5 days
|
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
Time Frame: At study completion, up to 6 days
|
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
Time Frame: At study start, day 2 and at study completion, up to 6 days
|
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.
Time Frame: At study start, day 2 and at study completion, up to 6 days
|
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
Time Frame: At study start, day 1 and at one week afetr the study completion, up to 12 days
|
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INSPIRE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Use of the Atalante exoskeleton
-
WandercraftRecruitingCerebrovascular Disorders | Stroke, Ischemic | Stroke, Acute | Stroke Hemorrhagic | Hemiparesis | Cerebrovascular Accident | Hemiparesis;Poststroke/CVA | Stroke, Subacute | Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)Germany, France, Spain
-
WandercraftCompletedStroke | Stroke, Acute | Robotics | Stroke, SubacuteFrance
-
WandercraftCompletedSpinal Cord Injuries | Paraplegia | Robotics | Lower Extremity | Paralysis, Lower LimbsFrance
-
Institut de Recherche sur la Moelle épinière et...Groupe Hospitalier Pitie-Salpetriere; Institut de Myologie, France; Association... and other collaboratorsRecruitingALS - Amyotrophic Lateral SclerosisFrance
-
Cliniques universitaires Saint-Luc- Université...Recruiting
-
WandercraftCompletedComplete Motor ParaplegiaFrance
-
MarsiBionicsFundacion para la Investigacion Biomedica del Hospital Universitario Ramon...CompletedSpinal Muscular Atrophy Type IISpain
-
Roessingh Research and DevelopmentCompleted
-
Aalborg UniversityDagrofa Logistics A/SRecruitingWork-related Musculoskeletal DisordersDenmark
-
University of RzeszowDonum Corde Rehabilitation CenterNot yet recruitingNervous System Diseases | Physical Activity | Neurorehabilitation | Biomedical Enhancement