SHAJA-R hip exoskeleton to improve walking after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• SD Neuroriabilitazione - Azienda Ospedaliero Universitaria Pisana
  Pisa, Italy, Italy Recruiting
• Centro Riabilitativo Villa Beretta
  Costa Masnaga, Italy, Italy Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.