Testing a hip exoskeleton to help walking after stroke
Compares a hip exoskeleton walking program with usual training in stroke patients.
Plain-language title generated from the registry record
Registry title: Post-stroke Gait Rehabilitation Using the SHAJA-R Exoskeleton
Key facts
- Where
- Costa Masnaga and Pisa, ItalySee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07035730, who can take part
Where in Italy
- Centro Riabilitativo Villa BerettaCosta Masnaga, ItalyNot yet recruiting
- SD Neuroriabilitazione - Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Carmelo Chisari
- Trial code
- NCT07035730
- Record updated
- 19 August 2025
- Original description
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.Read full original descriptionShow less
Post-stroke Gait Rehabilitation With a Unilateral Hip Exoskeleton: Clinical and Neuromuscular Outcomes
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
Inclusion: 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: major orthopaedic surgery or fractures within the last 90 days (hip, knee, ankle, foot, spine); 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); skin wounds, infection, or problems at device contact locations; cardiac surgery within the last 3 months; implanted cardiac devices, such as pacemakers or automatic defibrillators (AICD); 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; 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; patient has recently or is currently participating in research that may influence, in PI's opinion, responses to study intervention; pregnancy; use of assistive device that, in the PI's opinion, could interfere with SHAJA.