Post-stroke Gait Rehabilitation Using the SHAJA-R Exoskeleton

Official title

Post-stroke Gait Rehabilitation With a Unilateral Hip Exoskeleton: Clinical and Neuromuscular Outcomes

Overview

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

Interventions

• Device Unilateral hip exoskeleton
  Unilateral hip exoskeleton assisted gait training. Gait training will consist of overground walking with the exoskeleton SHAJA for 30-40 minutes.
• Behavioral Conventional gait training
  Conventional gait training will consist of overground walking without the exoskeleton SHAJA for 30-40 minutes.

Primary outcome measures

• Number of device-related adverse events [Time frame: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1]
• Documenting device hardware and software malfunctions [Time frame: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1]
• Changes in self-selected walking velocity (m/s) pre vs post Conventional training and SHAJA-assisted training interventions assessed with the 10 Metre Walk Test [Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]
• Changes in fast walking velocity (m/s) pre vs post Conventional training and SHAJA-assisted training interventions assessed with the 10 Metre Walk Test [Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]
• Changes in the difference between self-selected and fast walking velocity (delta m/s) pre vs post Conventional training and SHAJA-assisted training interventions assessed with the 10 Metre Walk Test [Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]
• Changes in walking endurance (in minutes) pre vs post Conventional training and SHAJA-assisted training interventions assessed with a Walk Test [Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]

Secondary outcome measures (6)

• Changes in gait kinematics/kinetics pre vs post Conventional training and SHAJA-assisted training interventions assessed with a motion capture system [Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]
• Changes in the execution time of the Timed-Up-and-Go (TUG) test pre vs post Conventional training and SHAJA-assisted training interventions [Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]
• Changes in Berg Balance Scale pre vs post Conventional training and SHAJA-assisted training interventions [Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]
• Changes in Motricity Index for Lower Limb pre vs post Conventional training and SHAJA-assisted training interventions [Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]
• Changes in Modified Ashworth Scale (MAS) pre vs post Conventional training and SHAJA-assisted training interventions [Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]
• Changes in Functional Ambulation Classification (FAC) pre vs post Conventional training and SHAJA-assisted training interventions [Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 2 centers

• Centro Riabilitativo Villa Beretta — Costa Masnaga
• SD Neuroriabilitazione - Azienda Ospedaliero Universitaria Pisana — Pisa

Identifiers

NCT: NCT07035730 · 0003812/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗