Post-stroke Gait Rehabilitation Using the SHAJA-R Exoskeleton

Launched by CARMELO CHISARI · Jun 20, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a special robotic device called the SHAJA exoskeleton to help people who have had a stroke improve their walking speed and stamina. The main goal is to see if training with the SHAJA device is safe and if it helps patients walk better compared to usual physical therapy methods. Researchers will compare the results of walking training with the SHAJA exoskeleton to conventional walking exercises to find out which is more effective.

People who might join this study are adults who had a stroke at least three months ago and can already walk a little bit with or without help, but still have some difficulty, especially with hip movement. Participants should be able to understand simple instructions and not have other serious health problems that could make the training unsafe. Those who take part will attend six training sessions using either the SHAJA device or traditional therapy, along with five assessments to check their progress. This study is not yet recruiting, but it aims to discover if this new technology could offer better support for walking rehabilitation after a stroke.

Gender

ALL

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