SHAJA-R hip exoskeleton to improve walking after stroke
Post-stroke Gait Rehabilitation With a Unilateral Hip Exoskeleton: Clinical and Neuromuscular Outcomes
This will test whether a hip exoskeleton called SHAJA-R helps people recovering from stroke walk faster and farther than conventional gait training.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Pisa Academic / other |
| Locations | 2 sites (Costa Masnaga, Italy and 1 other locations) |
| Trial ID | NCT07035730 on ClinicalTrials.gov |
What this trial studies
The trial randomly compares six sessions of SHAJA-assisted gait training using a unilateral hip exoskeleton to six sessions of conventional gait training, with five assessment visits to measure outcomes. Its primary goals are to test short-term safety, device reliability, and effects on walking velocity and endurance in people at least three months after a cerebral stroke. Participants are selected for ambulatory ability (self-selected speed 0.3–0.85 m/s), minimal contact assistance allowance, compatible body dimensions, and hip weakness amenable to powered assistance. Key exclusions include marked spasticity, significant cognitive or communication impairment, and recent or uncontrolled serious medical conditions.
Who should consider this trial
Good fit: Ideal candidates are people at least three months after a cerebral stroke who can ambulate with no more than minimal contact assistance, have a self-selected walking speed between 0.3 and 0.85 m/s, and exhibit hip weakness that may respond to powered assistance.
Not a fit: Patients with high spasticity (Modified Ashworth Scale >3), poor cognition (corrected MMSE <21), inability to follow multi-step commands or severe aphasia, recent myocardial infarction, uncontrolled heart failure or hypertension, or uncontrolled seizures are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, SHAJA-R training could help post-stroke patients walk faster and farther, improving independence and mobility.
How similar studies have performed: Previous small studies of wearable exoskeletons and robotic-assisted gait training have shown promising short-term gains in walking speed and endurance, but results are variable and devices differ.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Costa Masnaga, Italy and 1 other locations
- Centro Riabilitativo Villa Beretta — Costa Masnaga, Italy, Italy (Not_yet_recruiting)
- SD Neuroriabilitazione - Azienda Ospedaliero Universitaria Pisana — Pisa, Italy, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.