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

Обзор

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.

Вмешательства

• Устройство Use of the Atalante exoskeleton
  Six weeks of exoskeleton sessions replacing conventional therapy sessions three times a week

Первичные конечные точки

• 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. [Срок оценки: End of the intervention period (week 6)]

Вторичные конечные точки (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. [Срок оценки: 6 months post stroke]
• Time to reach FAC score of 4 or higher [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)]
• Changes in maximal clinical muscle extensibility XV1 and maximal range of active motion XA against the resistance of the key lower limb muscles using the Five Step Assessment [Срок оценки: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)]
• Changes in anxiety and depression scores using the Hospital and Depression scale (HAD) [Срок оценки: Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days)]
• Changes in perceived quality of life assessed by the Short Form-36 (SF-36) [Срок оценки: Day 1 (± 3 days) and 6 months post stroke (± 6 days)]
• Subject and Therapist satisfaction and willingness to continue training sessions [Срок оценки: End of Week 1 (± 3 days), end of Week 3 (± 3 days) and end of the intervention period (Week 6 ± 3 days)]
• Perceived workload by the therapists conducting sessions assessed with the NASA Task Load Index [Срок оценки: End of Week 1 (± 3 days) and end of the intervention period (Week 6 ± 3 days)]

Критерии участия

Критерии включения

• >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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 2 центра

• Hôpitaux Universitaires Henri Mondor APHP, site Albert Chenevier — Créteil
• Centre de Médecine Physique et de Réadaptation APAJH de Pionsat — Pionsat

Германия · 2 центра

• Schön Klinik — Bad Aibling
• Vivantes Klinikum Spandau — Berlin

Испания · 1 центр

• Institut Guttmann — Barcelona

Идентификаторы

NCT: NCT06107010 · EarlyExo

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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