Screening and Rehabilitation of Visual Field Defects in Post-Stroke Patients

NCT07317739 | Not Yet Recruiting

• 1 other identifier: SCRiCaViPS
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, the investigators will use a wearable device capable of performing this bedside assessment to evaluate the incidence of visual field loss in post-stroke patients. Furthermore, for those with visual field loss, the investigators will investigate whether integrating multisensory audio-visual rehabilitation into the standard physical rehabilitation protocol can help improve visual field loss compared to standard rehabilitation alone.

Conditions

Hemianopia; Visual Field Defect Following Cerebrovascular Accident

Keywords

Post stroke visual defects; Screening; Visual field; Rehabilitation; Neurorehabilitation; visual-auditory stimulation

Outcome Measures

Primary Outcomes (2)

• Recovery rate in patients who receive training with multisensory audio-visual stimuli

  Visual field test (120pt neuro programme) per each eye at follow up compared with the screening test. The functional rate will be in percentage (on 124 stimuli) adding 1 integer for seen points, 0.5 for relative points

  2 months

• Spontaneous recovery rate of visual field defects after stroke

  Visual field test (120pt neuro programme) per each eye at follow up compared with the screening test. The functional rate will be in percentage (on 124 stimuli) adding 1 integer for seen points, 0.5 for relative points

  2 months

Secondary Outcomes (1)

• Incidence of visual field defects in post-stroke patients

  1 year

Study Arms (2)

Standard intervention

OTHER

This group of patients will continue according to current clinical practice (control group), directed towards possible neuro-motor rehabilitation until full recovery, and will have access to visual rehabilitation following full recovery of physical condition. The follow up visual field test will detect the percentage of spontaneous recovery of the visual field defect during the observation period

Diagnostic Test: Early visual field test

Early intervention rehabilitation

EXPERIMENTAL

The experimental group will be enrolled for a early rehabilitation intervention through multisensory stimulations, a rehabilitation specifically aimed at improving the visual field deficit, possibly combined with standard physical rehabilitation in temporary hospitalization facilities or protected hospital discharge.

Other: Early multisensory audio-visual stimulation training; Diagnostic Test: Early visual field test

Interventions

Early multisensory audio-visual stimulation training OTHER

Multisensory audio-visual stimulation training (using the device AV DESK Linari Medical) will last four weeks. Through audiovisual stimuli produced by the Av-Desk Flexi device, patients undergo a brain cell training program that compensates for blind spots in their visual field. The recipes regulating the combinations of stimuli are provided daily, under the supervision of a physician, where the data processing unit manages the data from the stimuli provided to the patient, their response to said stimuli, and monitors their position. The follow up visual field test will detect whether early intervention with multisensory audio-visual stimuli can improve visual field loss

Also known as: audio-visual stimulation

Early intervention rehabilitation

Early visual field test DIAGNOSTIC_TEST

Visual field assessment with wearable devices (PalmScan VF2000) performed at the bedside in post-stroke patients who met the inclusion criteria during their stay in the neurology hospital unit, as soon as they were stabilized. Standard 120-point visual field tests will be performed on the left and right eyes separately, with the following quantification parameters: test duration, fixation losses, false positives, false negatives, points seen, points not seen, relative defects. Patients with a monocular residual perimetric defect of less than 106 points seen out of 124 (equal to 85% of the stimuli presented) and in any case with a defect greater than 12 points if presented in a single quadrant, will be selected for the clinical trial and invited to repeat the same visual field evaluation, using the same wearable devices in the 2-months follow-up.

Early intervention rehabilitation; Standard intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 99 years with stroke (excluding isolated cerebellar, brainstem, or spinal cord strokes), admitted to Neurology in IRCCS San Martino Polyclinic Hospital with the ability to understand and sign the informed consent for study participation.
• Mobility of at least one upper limb.

You may not qualify if:

• Presence of cognitive impairment (with an MMSE score less than 24), which limits the understanding of the informed consent or the ability to perform the test.
• Difficulty moving both upper limbs.
• Presence of ocular comorbidity that could affect visual field assessment before stroke.
• Presence of fluent aphasia, neglect, or head and gaze deviation.
• Presence of disturbances in the state of consciousness
• Presence of delirium

Sponsors & Collaborators

• Fondazione David Chiossone - Impresa Sociale: lead
• IRCCS AOU San Martino, Genova, Italy: collaborator

MeSH Terms

Conditions

Hemianopsia

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Angelo Schenone, Prof.

  University of Genova DINOGMI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Cianciosi, Dr

CONTACT

0039 1083421; cianciosi@chiossone.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study type: interventional. Allocation: randomized Intervention model: parallel assignment (1:1) This study involves two treatment groups of post-stroke patients with visual field defects identified during the screening activity.

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share