Use of the Atalante exoskeleton
DeviceSix weeks of exoskeleton sessions replacing conventional therapy sessions three times a week
NCT Number: NCT06107010
The present clinical investigation - EarlyExo, is an interventional, international, multicentric, prospective, single-blinded randomized controlled trial.
This clinical investigation is designed to test the hypothesis that early and intense introduction of walking sessions assisted by the Atalante exoskeleton, in a sample of hemiparetic patients with still non or poor ambulatory capacities (FAC 0 or 1) between one- and four-months post stroke, would result in a better recovery of functional walking compared to a control group only receiving conventional therapy. Improved recovery will be measured through the proportion of patients reaching a FAC score of 4 or higher at the end of the intervention period. The tested hypothesis is that this proportion will be higher in the Exo group.
The duration of the intervention period in both groups is 6 weeks.
* For the Exo group: 3 sessions per week (i.e., 18 one-hour sessions) with the Atalante device and 2 sessions per week (i.e., 12 one-hour sessions) of conventional therapy. * For the Control group: 5 sessions per week of conventional therapy (i.e., 30 one-hour sessions).
The study will include 66 patients (33 in each arm) and takes place in two French centers, two German centers and one Spanish center.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hôpitaux Universitaires Henri Mondor APHP, site Albert Chenevier, Créteil, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Six weeks of exoskeleton sessions replacing conventional therapy sessions three times a week
Time frame: End of the intervention period (week 6)
The FAC is a 6-item ordinal scale that classifies the level of support needed to walk safely, irrespective of the use of a lower extremity orthosis or walking aid, ranging from 0 (unable to walk without the assistance of two people) to 5 (independent walking on uneven surfaces and on stairs).
Time frame: 6 months post stroke
Time frame: Day 1 (± 3 days), week 2 (± 3 days) and week 4 (± 3 days) after the beginning of the intervention period, end of the intervention period (Week 6 ± 3 days), discharge from hospital and 6 months post stroke (± 6 days).
Time frame: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)
The 10MWT is used to assess gait speed in meters/second over a short distance. Two tests are successively administered, barefoot, at comfortable then at maximal walking speed without walking aids. If a patient is unable to ambulate at all, a score of 0 m/s is documented.
Time frame: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)
The BBS is a subjective, ordinal scale that assesses the ability to safely balance and avoid falls, during a series of functional tasks. It is thus also a measure of the amount of assistance needed to perform these tasks safely. In most items, the subject must maintain a given position for a specified time or complete moving tasks of varying difficulty. Subject receives a score from 0-4 at each of the 14 items on the ability to meet these balance dimensions.
Time frame: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)
The purpose is to record the time needed by the patient to do the transfer wheelchair /toilet seat/ wheelchair. Reduction of this time could mean an improvement of independence in daily life for stroke patients for whom transferring to the toilet is a common difficulty.
Time frame: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)
Measurements of XV1 and XA for soleus, gastrocnemius, gluteus maximus, hamstrings, vastus and rectus femoris muscles, using to the Five Step Assessment
Time frame: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)
The HAD is a two-dimension self-administered questionnaire developed to identify depression and anxiety among physically ill patients. Identifying these disorders and the context in which they develop is interesting as motivation of the patient seems to have an important impact on his progression. It consists of 14 items rated with a score from 0-4, divided into 7 items for anxiety and 7 items for depression based on the concept of anhedonia.
Time frame: Day 1 (± 3 days) and 6 months post stroke (± 6 days)
The SF-36 is a self-administered questionnaire that provides an evaluation of the generic Quality of Life. The version used is the RAND-36 Item Health Survey. There are 36 items (or questions) divided into eight domains:
Physical component:
Mental component:
Time frame: End of Week 1 (± 3 days), end of Week 3 (± 3 days) and end of the intervention period (Week 6 ± 3 days)
The subject is asked to answer two questions regarding his satisfaction and willingness to continue training sessions. The therapist answers one question on his satisfaction. The score of each question is evaluated with a 5-level Likert scale.
Time frame: End of Week 1 (± 3 days) and end of the intervention period (Week 6 ± 3 days)
The NASA Task Load Index is a multidimensional, subjective scale that rates perceived workload in order to assess a task.There are six items, answered by the therapists after the therapy session:
Contact information is provided by the study sponsor or research team.
Dr Rebecca Sauvagnac, MD
CONTACT
Laure Bouché
CONTACT
Wandercraft
Industry
Acronym: EarlyExo
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06575140
Brain Diseases, Cardiovascular Diseases
Mexico City, Mexico
View Trial DetailsNCT04770363
Behavior, Brain Diseases
Alexandria, Egypt
View Trial DetailsNCT06121336
Brain Diseases, Brain Injuries
Munich, Bavaria, Germany
View Trial DetailsNCT05179473
Brain Diseases, Cardiovascular Diseases
Montreal, Quebec, Canada
View Trial Details