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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorFondazione David Chiossone - Impresa Sociale

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early multisensory audio-visual stimulation training

    Other intervention

    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

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Standard interventionOther 1 intervention
Group B: Early intervention rehabilitationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
2 months
2

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

Time frame
2 months

Secondary outcomes

1

Incidence of visual field defects in post-stroke patients

Number of patients with visual field defects, will be compared with literature and retrospective study on clinical records of the hospital neurology clinic.

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione David Chiossone - Impresa Sociale

Lead sponsor

IRCCS AOU San Martino, Genova, Italy

Collaborator

This trial is not recruiting at the moment. You can still explore other options: