NCT06107010Recruiting
Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)
Source: ClinicalTrials.gov · Last updated 4 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 24 Oct 2023
- Start date
- 12 Jun 2023
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- Wandercraft
- Diseases
- Stroke
- NCT number
- NCT06107010
What you commit to
- Study type: Interventional
- Planned participants: 66
- From 12 Jun 2023 to the primary completion date, 28 Feb 2026
- 5 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent fracture (\< 3 months) or any therapy inducing secondary osteoporosis
- Concurrent participation in another interventional trial
Other illness
- Pressure sore grade I or more over contact zones with Atalante system, according to the International Pressure Ulcer Classification System NPUAP - EPUA
- Uncontrolled seizures
Other
- Muscle overactivity in hip adductors, hamstrings, quadriceps and plantar flexors, which interferes with exoskeleton use, based on clinician investigator's opinion
- Excessive joint mechanical pain in the lower limbs based on clinician investigator's opinion
- Medical contra-indication to medium intensity physical strain
- Orthostatic hypotension (loss of \> 20 mmHg systolic BP after 3 minutes in standing position)
- 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
Who the study is looking for
- \>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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Schön Klinik Coordinator of this site? Confirm its status | Bad Aibling | Germany | Not yet recruiting |
| Vivantes Klinikum Spandau Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Institut Guttmann Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hôpitaux Universitaires Henri Mondor APHP, site Albert Chenevier Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
| Centre de Médecine Physique et de Réadaptation APAJH de Pionsat Coordinator of this site? Confirm its status | Pionsat | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.