💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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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