Using the Atalante exoskeleton to help stroke patients walk again

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation, known as EarlyExo, is an international, multicentric, prospective, single-blinded randomized controlled trial aimed at assessing the effectiveness of the Atalante exoskeleton in improving walking recovery in hemiparetic patients who have limited mobility due to stroke. Participants will be divided into two groups: one receiving intensive walking sessions with the exoskeleton and the other receiving conventional therapy. The study will measure the proportion of patients achieving a higher functional ambulation category score after six weeks of intervention. The goal is to determine if the exoskeleton-assisted therapy leads to better functional outcomes compared to standard rehabilitation methods.

Why it matters

Who can join: the full rules

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 interventional trial

Where it's running

• Hôpitaux Universitaires Henri Mondor APHP, site Albert Chenevier
  Créteil, France Recruiting
• Centre de Médecine Physique et de Réadaptation APAJH de Pionsat
  Pionsat, France Recruiting
• Vivantes Klinikum Spandau
  Berlin, Germany Recruiting
• Institut Guttmann
  Barcelona, Spain Recruiting
• Schön Klinik
  Bad Aibling, Germany Not yet recruiting

Study contacts

• Study coordinator: Dr Rebecca Sauvagnac, MD
• Email: rebecca.sauvagnac@wandercraft.health
• Phone: (0)179353109

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Collecting data from patients admitted to the Stroke unit

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• Inter-Limb Transfer after Acute Stroke

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.