Post-stroke Gait Rehabilitation Using the SHAJA-R Exoskeleton

Официальное название

Post-stroke Gait Rehabilitation With a Unilateral Hip Exoskeleton: Clinical and Neuromuscular Outcomes

Обзор

The goal of this clinical trial is to evaluate the safety, reliability, and short-term effectiveness of SHAJA-based training in improving walking velocity and endurance in post-stroke patients. The main questions it aims to answer are: * Does the SHAJA-based training improve walking velocity and endurance in post-stroke patients compared to conventional gait training? * Is the SHAJA exoskeleton safe and reliable? Researchers will compare the SHAJA-based training to a conventional gait training to see if the former works to improve walking ability. Participants will: * Perform six SHAJA-assisted gait training sessions or six conventional gait training sessions * Perform five assessment sessions

Вмешательства

• Устройство Unilateral hip exoskeleton
  Unilateral hip exoskeleton assisted gait training. Gait training will consist of overground walking with the exoskeleton SHAJA for 30-40 minutes.
• Поведенческое Conventional gait training
  Conventional gait training will consist of overground walking without the exoskeleton SHAJA for 30-40 minutes.

Первичные конечные точки

• Number of device-related adverse events [Срок оценки: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1]
• Documenting device hardware and software malfunctions [Срок оценки: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1]
• Changes in self-selected walking velocity (m/s) pre vs post Conventional training and SHAJA-assisted training interventions assessed with the 10 Metre Walk Test [Срок оценки: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]
• Changes in fast walking velocity (m/s) pre vs post Conventional training and SHAJA-assisted training interventions assessed with the 10 Metre Walk Test [Срок оценки: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]
• Changes in the difference between self-selected and fast walking velocity (delta m/s) pre vs post Conventional training and SHAJA-assisted training interventions assessed with the 10 Metre Walk Test [Срок оценки: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]
• Changes in walking endurance (in minutes) pre vs post Conventional training and SHAJA-assisted training interventions assessed with a Walk Test [Срок оценки: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]

Вторичные конечные точки (6)

• Changes in gait kinematics/kinetics pre vs post Conventional training and SHAJA-assisted training interventions assessed with a motion capture system [Срок оценки: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]
• Changes in the execution time of the Timed-Up-and-Go (TUG) test pre vs post Conventional training and SHAJA-assisted training interventions [Срок оценки: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]
• Changes in Berg Balance Scale pre vs post Conventional training and SHAJA-assisted training interventions [Срок оценки: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]
• Changes in Motricity Index for Lower Limb pre vs post Conventional training and SHAJA-assisted training interventions [Срок оценки: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]
• Changes in Modified Ashworth Scale (MAS) pre vs post Conventional training and SHAJA-assisted training interventions [Срок оценки: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]
• Changes in Functional Ambulation Classification (FAC) pre vs post Conventional training and SHAJA-assisted training interventions [Срок оценки: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]

Критерии участия

Критерии включения

• cerebral stroke, at least 3 months from cerebral event
• ability to ambulate with no more than minimal contact assistance, even with aids (Functional Ambulation Classification, FAC >= 43)
• self-selected walking velocity in the range \[0.3-0.85\] m/s
• anthropometry consistent with the specifications of the tested devices
• gait impairments that may benefit from hip assistance, e.g. hip weakness in flexion and/or extension (Medical Research Council, MRC, Scale for Muscle Strength >2 and <5 for flexion and extension)

Критерии исключения

• Modified Ashworth Scale >3 at the hip and/or ankle joints
• Poor cognitive skills (corrected Mini-Mental State Examination, MMSE < 21)
• inability to follow verbal 3 step commands
• severe aphasia causing inability to communicate with the investigators
• serious medical conditions (recent myocardial infarction in less than 3 months, uncontrolled congestive heart failure (CHF), uncontrolled hypertension, uncontrolled seizures)
• leg deep vein thrombosis less than 6 weeks ago
• other pre-existing neurological disorders (Parkinson's disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Dementia)
• severe anxiety or depression (State-Trait Anxiety Inventory-Y, STAI-Y > 44, and the Beck Depression Inventory-II, BDI-II > 19)
• severe osteoporosis
• severe hip / knee osteoarthritis with limitation of movement or significant pain
• use of a colostomy bag
• skin wounds, infection, or problems at device contact locations
• major orthopaedic surgery or fractures within the last 90 days (hip, knee, ankle, foot, spine)
• cardiac surgery within the last 3 months
• patient has recently or is currently participating in research that may influence, in PI's opinion, responses to study intervention
• pregnancy
• implanted cardiac devices, such as pacemakers or automatic defibrillators (AICD)
• use of assistive device that, in the PI's opinion, could interfere with SHAJA

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 2 центра

• Centro Riabilitativo Villa Beretta — Costa Masnaga
• SD Neuroriabilitazione - Azienda Ospedaliero Universitaria Pisana — Pisa

Идентификаторы

NCT: NCT07035730 · 0003812/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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