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

NCT ID: NCT07317739

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-03-31

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.

Detailed Description

The objectives of the research are:

1. To quantify the incidence and severity of visual field defects in subjects with a recent cerebrovascular accident admitted to the hospital Neurology Unit

2. To evaluate the rate of spontaneous recovery of visual field defects during observation .

3. To test the effectiveness of an early and intensive visual rehabilitation intervention based on multisensory stimulation in reducing the severity of the aforementioned visual defect.

The research is planned to be conducted in Genova Italy and to include 300 patients.

In this study, the investigators will recruit acute post-stroke patients from the Neurology Unit of IRCCS Policlinico San Martino hospital. The study will use a wearable device (PalmScan VF2000) to assess the visual field defects. Those with significant visual field defects will be randomly assigned to either the visual rehabilitation group, receiving visual rehabilitation treatment integrated into their physical rehabilitation protocol, or the standard group. Inclusion criteria include: age between 18 and 90 years, post-stroke patients (excluding isolated cerebellar, brainstem, or spinal cord strokes), admitted to the Neurology Unit of the IRCCS Policlinico San Martino hospital, able to understand and sign the informed consent for study participation, and having mobility in at least one upper limb. Exclusion criteria include: cognitive impairment that limits understanding of the informed consent or testing, difficulty with both upper limb movements, presence of ocular comorbidity that could affect pre-ictal visual field assessment, presence of fluid aphasia, neglect or deviation of the head and gaze, impaired consciousness or delirium. Baseline assessments will be conducted at the Neurology Unit of the IRCCS Policlinico San Martino hospital.

After the baseline assessment, all participants diagnosed with visual field impairment will be assigned to the David Chiossone Foundation, with the option of being referred to a post-acute residential facility or undergoing outpatient treatment. Otherwise, patients requiring intensive care will be referred to another competent local center.

Participants will be randomly divided into two groups:

• one will receive an early visual rehabilitation protocol (experimental group), possibly supplemented with neuromotor rehabilitation, immediately after discharge from the Neurology Unit of the IRCCS Policlinico San Martino hospital, with a four-week intensive stimulation protocol. Visual rehabilitation will be administered with multisensory audiovisual stimulation (AvDesk) five days a week.
• another group will continue according to current clinical practice (control group), potentially receiving neuromotor rehabilitation until full recovery, and will have access to visual rehabilitation thereafter through the access procedures agreed with the Italian National Health Service.

After 8 weeks since they are dismissed by the hospital Neurology Unit, all patients (even those not receiving vision rehabilitation) will receive a follow-up visual field assessment using the wearable device at the David Chiossone Foundation - for the rehabilitation of blind, visually impaired, and frail people - Social Enterprise.

Conditions

Hemianopia; Visual Field Defect Following Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard intervention

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

Group Type: OTHER

Early visual field test

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Early multisensory audio-visual stimulation training

Intervention Type: 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

Early visual field test

Intervention Type: 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.

Interventions

Early multisensory audio-visual stimulation training

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

Intervention Type: OTHER

Early visual field 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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

audio-visual stimulation

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Mobility of at least one upper limb.

Exclusion Criteria

1. 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.

2. Difficulty moving both upper limbs.

3. Presence of ocular comorbidity that could affect visual field assessment before stroke.

4. Presence of fluent aphasia, neglect, or head and gaze deviation.

5. Presence of disturbances in the state of consciousness

6. Presence of delirium

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS AOU San Martino, Genova, Italy

UNKNOWN

Sponsor Role: collaborator

Fondazione David Chiossone - Impresa Sociale

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angelo Schenone, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Genova DINOGMI

Central Contacts

Paola Cianciosi, Dr

Role: CONTACT

cianciosi@chiossone.it

0039 1083421

Other Identifiers

SCRiCaViPS

Identifier Type: -

Identifier Source: org_study_id