Intensive Visual Simulation before exoskeleton gait training in people with hemisensory brain injury

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

This randomized, blinded study compares two rehabilitation approaches for adults with recent cerebrovascular-related hemisensory deficits. Arm A uses a 15-minute Intensive Visual Simulation before 30 minutes of Ekso exoskeleton gait training followed by 45 minutes of non-robotic therapy; Arm B uses the same regimen without the IVS step. Sessions occur five days a week for three weeks, with evaluations by a blinded physician to assess independence in walking. The trial involves a single center in Italy and excludes individuals with major comorbidities or severe cognitive or motor impairments that would limit safety or protocol adherence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male and female patients aged 18 to 80 years (both ends included).
* Diagnosis of hemiparesis/plegia with proprioceptive sensory deficit due to a cerebrovascular event within the last 6 months
* Orientation in the 3 domains (space, time, and person)
* Cooperation
* Clinical stability
* Trunk control while standing
* Signature of the Informed Consent Form for participation in the study and for the processing of personal data

Exclusion Criteria:

* Patients aged \< 18 years and \> 80 years
* Patients who are disoriented in at least one of the three domains (space, time, and person)
* Non-cooperative patients
* Patients with global aphasia
* Patients with severe ideomotor apraxia
* Patients with cognitive or mental disorders
* Patients not eligible for EKSO:
* Severe comorbid conditions: infections, circulatory, cardiac, or pulmonary diseases, pressure ulcers.
* Severe spasticity (level 4 on the modified Ashworth scale).
* Spinal instability or unhealed fractures of the limbs or pelvis.
* Heterotopic ossification.
* Psychiatric or cognitive conditions that may interfere with the proper use of the device.
* Pregnant women.
* Reduced tolerance for standing due to orthostatic hypotension.
* Range of motion (ROM) limitations that would prevent the patient from achieving a normal bilateral gait pattern or performing normal transitions from a seated to a standing position and vice versa: Bilateral hip flexion less than 110°, knee flexion contracture greater than 12°, or inability to achieve neutral dorsiflexion of 0° with knee flexion up to 12°.
* Leg length discrepancy greater than 1.27 cm for the upper leg and 1.9 cm for the lower leg.
* Unresolved deep vein thrombosis.
* Uncontrolled autonomic dysreflexia.
* Lower limb prostheses.

Where it's running

• IRCCS Sacro Cuore Don Calabria Hospital
  Negrar, Italy, Italy Recruiting

Study contacts

• Study coordinator: Elvia Malo, Dr.
• Email: ricerca.clinica@sacrocuore.it
• Phone: +39 045.6014877

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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.