Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemip… (NCT06107010) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)
France, Germany, Spain66 participantsStarted 2023-06-12
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \>18 years old
* First clinically significant disability due to stroke
* Hemiparesis in acute-subacute phase (1 to 4 months since lesion) due to a stroke
* Functional Ambulation Category score (FAC) \<2
* Patient with health insurance
* Informed and willing to sign an informed consent form approved by the Ethics Committee. For clarity, if a motor impairment prevents the subject from signing by himself, he/she can still be included if the signature can be done by an impartial witness.
Exclusion Criteria:
* Muscle overactivity in hip adductors, hamstrings, quadriceps and plantar flexors, which interferes with exoskeleton use, based on clinician investigator's opinion
* Recent fracture (\< 3 months) or any therapy inducing secondary osteoporosis
* Excessive joint mechanical pain in the lower limbs based on clinician investigator's opinion
* Pressure sore grade I or more over contact zones with Atalante system, according to the International Pressure Ulcer Classification System NPUAP - EPUA
* Medical contra-indication to medium intensity physical strain
* Orthostatic hypotension (loss of \> 20 mmHg systolic BP after 3 minutes in standing position)
* Uncontrolled seizures
* Morphological contra-indications to the use of Atalante (as per user's manual)
* Pregnant woman
* Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention
* Concurrent participation in another inter…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Walking recovery expressed by the proportion of patients reaching a Functional Ambulation Category (FAC) score of 4 or higher at the end of the intervention period, assessed without the exoskeleton.
Timeframe: End of the intervention period (week 6)