NCT07035730 Post-stroke Gait Rehabilitation Using the SHAJA-R Exoskeleton

Eligibility & Interventions

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This trial targets 20 participants in total. It began in 2025-07-07 with a primary completion date of 2026-12-31.

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: * 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) Exclusion Criteria: * 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

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