Post-stroke Gait Rehabilitation Using the SHAJA-R Exoskeleton

Carmelo Chisari

Status: Enrolling

Conditions: Stroke

Treatments: Device: Unilateral hip exoskeleton; Behavioral: Conventional gait training

Study type: Interventional

Funder types: Other

Identifiers

NCT07035730

0003812/2025

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

SHAJA first, then conventional

Experimental group

Description:

Patients will perform the SHAJA-assisted gait training during the first period of the trial followed by a conventional gait training during the second period of the trial

Treatment:

Behavioral: Conventional gait training

Device: Unilateral hip exoskeleton

Conventional first, then SHAJA

Experimental group

Description:

Patients will perform the conventional gait training during the first period of the trial followed by a SHAJA-assisted gait training during the second period of the trial

Treatment:

Behavioral: Conventional gait training

Device: Unilateral hip exoskeleton