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

Fondazione David Chiossone - Impresa Sociale

Status: Not yet enrolling

Conditions: Visual Field Defect Following Cerebrovascular Accident; Hemianopia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07317739

SCRiCaViPS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Standard intervention

Other group

Description:

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

Treatment:

Diagnostic Test: Early visual field test

Early intervention rehabilitation

Experimental group

Description:

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.

Treatment:

Other: Early multisensory audio-visual stimulation training

Diagnostic Test: Early visual field test