Post-stroke Gait Rehabilitation Using the SHAJA-R Exoskeleton

NCT07035730 · tracked via the Priya Life Science Italy tracker

Sponsor

Carmelo Chisari

Phase

Not applicable

Started

2025-07-07

Last updated

2025-08-19

Condition(s) studied

Stroke

Investigational drug(s) / intervention(s)

Unilateral hip exoskeletonConventional gait training

Unilateral hip exoskeleton: Unilateral hip exoskeleton assisted gait training. Gait training will consist of overground walking with the exoskeleton SHAJA for 30-40 minutes.

Conventional gait training: Conventional gait training will consist of overground walking without the exoskeleton SHAJA for 30-40 minutes.

Study 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

Sex

ALL

Min age

18 Years

Max age

80 Years

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

Primary outcome measure(s)

Number of device-related adverse events — From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1
Documenting device hardware and software malfunctions — 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 — 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 — 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 — 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 — From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1

Trial sites (2)

Facility	City	Region	Status
Centro Riabilitativo Villa Beretta	Costa Masnaga	Italy	Not Yet Recruiting
SD Neuroriabilitazione - Azienda Ospedaliero Universitaria Pisana	Pisa	Italy	Recruiting

Other trials for the same condition

Effects of Using Advanced NEUROrehabilitation TECHnologies in Upper Limb Motor Function and Capacity Recovery in People With Stroke Recruiting

Evaluation of a Soft Elbow Exoskeleton and a Haptic Armband in Post-stroke and Parkinson's Disease Patients Starting soon

Evaluation of a Haptic Glove for Assessing Tactile Perception in Post-Stroke Patients Recruiting

Design and Validation of Innovative Strategies Based on Dual-Task Approach Active, not recruiting

Metaverse Applications in Clinical Neurorehabiliation: Device Feasibility Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07035730 on ClinicalTrials.gov ↗ ← All trials in Italy