Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)

Launched by WANDERCRAFT · Oct 24, 2023

Keywords

ClinConnect Summary

This clinical trial, called EarlyExo, is exploring whether using a special device called the Atalante exoskeleton can help people who have difficulty walking after a stroke. The study focuses on patients who are 1 to 4 months post-stroke and have very limited ability to walk. The goal is to see if patients who receive therapy with the exoskeleton can regain their walking ability better than those who only receive standard therapy. Participants will be divided into two groups: one group will use the exoskeleton for part of their therapy, while the other group will continue with regular therapy sessions. The study will last for 6 weeks, with different numbers of sessions for each group.

To join this trial, participants must be at least 18 years old, have had a stroke that affects one side of their body, and have a very limited ability to walk. Certain health conditions could prevent someone from participating, such as severe joint pain or recent fractures. If eligible, participants can expect to engage in therapy sessions three times a week with the exoskeleton, along with additional sessions of regular therapy. This trial is currently recruiting participants at several centers in France, Germany, and Spain, and is designed to help improve recovery for stroke patients who struggle with mobility.

Gender

ALL

Eligibility criteria

• 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