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

NCT06107010 | Recruiting DMC

• 1 other identifier: EarlyExo
• Study Type: interventional
• Target: 66
• Locations: 3 countries
• Sites: 5

Brief 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.

Conditions

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

Keywords

Robotics; Rehabilitation; Powered Exoskeleton; Walking recovery; Stroke; Acute stroke; Subacute stroke; Functional Ambulation Category; Randomized controlled study

Outcome Measures

Primary Outcomes (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.

  The FAC is a 6-item ordinal scale that classifies the level of support needed to walk safely, irrespective of the use of a lower extremity orthosis or walking aid, ranging from 0 (unable to walk without the assistance of two people) to 5 (independent walking on uneven surfaces and on stairs).

  End of the intervention period (week 6)

Secondary Outcomes (10)

• Walking recovery expressed by the proportion of patients reaching a FAC score of 4 or higher at six months post stroke, assessed without the exoskeleton.

  6 months post stroke

• Time to reach FAC score of 4 or higher

  Day 1 (± 3 days), week 2 (± 3 days) and week 4 (± 3 days) after the beginning of the intervention period, end of the intervention period (Week 6 ± 3 days), discharge from hospital and 6 months post stroke (± 6 days).

• Change in walking speed measured with the 10 Meter Walk Test (10MWT)

  Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)

• Changes in static and dynamic balance measured by the Berg Balance Scale (BBS)

  Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)

• Change in transfer time from wheelchair to toilet and back to wheelchair

  Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)

Study Arms (2)

Exo group

EXPERIMENTAL

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).

Device: Use of the Atalante exoskeleton

Control group

NO INTERVENTION

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

Interventions

Use of the Atalante exoskeleton DEVICE

Six weeks of exoskeleton sessions replacing conventional therapy sessions three times a week

Exo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wandercraft: lead

Study Sites (5)

Hôpitaux Universitaires Henri Mondor APHP, site Albert Chenevier

Créteil, France

RECRUITING

Centre de Médecine Physique et de Réadaptation APAJH de Pionsat

Pionsat, France

RECRUITING

Schön Klinik

Bad Aibling, Germany

NOT YET RECRUITING

Vivantes Klinikum Spandau

Berlin, Germany

RECRUITING

Institut Guttmann

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Cerebrovascular Disorders; Paresis; Hemiplegia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Central Study Contacts

Dr Rebecca Sauvagnac, MD

CONTACT

(0)179353109; rebecca.sauvagnac@wandercraft.health

Laure Bouché

CONTACT

(0)179353109; laure.bouche@wandercraft.health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single blind

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: June 12, 2023
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); DE (2); ES (1)