Post-stroke Gait Rehabilitation Using the SHAJA-R Exoskeleton
Post-stroke Gait Rehabilitation With a Unilateral Hip Exoskeleton: Clinical and Neuromuscular Outcomes
Carmelo Chisari
20 participants
Jul 7, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria18
- 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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Interventions
Unilateral hip exoskeleton assisted gait training. Gait training will consist of overground walking with the exoskeleton SHAJA for 30-40 minutes.
Conventional gait training will consist of overground walking without the exoskeleton SHAJA for 30-40 minutes.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07035730