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

Wandercraft

Status: Enrolling

Conditions: Cerebrovascular Accident; Hemiparesis;Poststroke/CVA; Stroke, Subacute; Stroke Hemorrhagic; Stroke, Acute; Hemiparesis; Cerebrovascular Disorders; Stroke, Ischemic; Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)

Treatments: Device: Use of the Atalante exoskeleton

Study type: Interventional

Funder types: Industry

Identifiers

NCT06107010

EarlyExo

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Exo group

Experimental group

Description:

During the 6-week intervention period, the Exo group will complete 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. During sessions with the exoskeleton, the patient will perform ambulatory exercises with the device, with a gradual increase of intensity through the sessions. Conventional therapy corresponds to physiotherapy as part of post stroke standard of care of the center (tasks such as lower and upper limb practice, walking in parallel bars, etc., but this list is not exhaustive and depends on the practice of the therapists/centers).

Treatment:

Device: Use of the Atalante exoskeleton

Control group

No Intervention group

Description:

During the 6-week intervention period, the Control group will complete 5 sessions per week of conventional therapy (i.e., 30 one-hour sessions).