An interventional study of Audio-visual training (AVT) telerehabilitation in Visual Field Defect Following Cerebrovascular Accident, Hemianopia and Brain Injuries, sponsored by Istituto Auxologico Italiano. Completed at 1 site in Italy. Open to participants aged 6 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Istituto Auxologico Italiano · Not applicable, Interventional, and Treatment
Brain injuries may cause the loss of the ability to see portions of the visual field, the so-called visual field defects (VFDs). VFDs significantly impact the survivors' functional recovery and quality of life, with the majority of patients displaying no spontaneous recovery or being left with residual deficits. Among the available therapies for VFDs, the compensatory scanning training is considered the most promising. Yet, current evidence is insufficient to recommend it in clinical practice, and the scientific community has stressed the need of more high-quality research. The present randomized clinical trial in patients with chronic VFDs caused by brain lesions aims at verifying the feasibility and efficacy of a novel telerehabilitation using a multisensory scanning therapy, by measuring its effects on visual functions and daily activities, and by looking for neural indicators of the therapy-induced improvements.
63 studies on the registry are indexed under Hemianopsia; 24 are open to participants now.
This study's enrollment of 72 is above the median of 32 across 53 interventional studies indexed under Hemianopsia.
Browse Hemianopsia studies →Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
not being enrolled in another VFDs therapy.
HVDFs patients who start the audio-visual telerehabilitation immediately
Behavioral: Audio-visual training (AVT) telerehabilitation
HVDFs patients waiting 1 month before receiving the audio-visual telerehabilitation.
Behavioral: Audio-visual training (AVT) telerehabilitation
A group of 12 healthy participants is recruited for comparisons of MRI-based connectivity metrics
Participants are trained at home, with remote supervision, for 3 weeks (5 days/week, 2 hours/day) using an audio-visual device suitable for telerehabilitation (AVDESK, Linari Medical). Specifically, visual stimuli (LEDs) appear on a semicircular panel, either alone or paired with an acoustic cues, at different eccentricities. Stimuli to the blind visual field (70%) and intact visual field (30%) are presented in random sequence. Patients are trained to scan the visual field by shifting their gaze (from the central fixation point) towards the visual target (with or without sounds), without head movements, and to report its presence by pressing the response key.
Change from baseline in Accuracy on the EF Task
Computerized visual search task. Participants have to search for the target letter "F" surrounded by distractors "E"s. RTs: median search times (seconds) of correct responses.
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups]
Change from baseline in Response Times (RTs) on the EF Task
Computerized visual search task. Participants have to search for the target letter "F" surrounded by distractors "E"s. RTs: median search times (seconds) of correct responses.
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups]
Change from baseline in Accuracy on the Triangle Task
Computerized visual search task. Participants have to report the number of triangles (targets) surrounded by square distractors. Accuracy: the proportion of correct responses (range 0-1)
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in RTs on the Triangle Task
Computerized visual search task. Participants have to report the number of triangles (targets) surrounded by square distractors. RTs: median search times (seconds) of correct responses.
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in RTs on the Numbers Task
Computerized visual search task. Participants have to point to numbers (1 to 15) in ascending order. RTs: median search times (seconds).
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in omissions on the Bell Test (only children)
Participants have to cross out Bells (targets) among different distractors. Omissions: number of omitted targets.
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in RTs on the Bell Test (only children)
Participants have to cross out Bells (targets) among different distractors. RTs: median search times (seconds).
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in Accuracy on the Small Faces Test (only children)
Participants have to cross out targets among distractors. Accuracy: the number of correct responses
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in RTs on the Small Faces Test (only children)
Participants have to cross out targets among distractors; RTs: median search times (seconds).
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in Daily Living Dependent on Vision Questionnaire (total score)
A scale assessing the impact of HVFDs on nine activities of daily living. For each item, the score ranges from 0 ("No difficulty") to 4 ("Very frequent difficulties")
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the Reading test (reading time)
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the Hamilton Anxiety Scale (total score; only adults)
A scale assessing the presence of anxiety
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the Beck's Depression Inventory (BDI; total score; only adults)
A scale assessing the presence of depressive symptoms
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the Multidimensional Anxiety Scale for Children (MASC; total score; only children)
A scale assessing the presence of anxiety in children
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the Children Depression Inventory (CDI; total score; only children)
A scale assessing the presence of depressive symptoms in children
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the visual field size (only adults)
Automated Humphrey Visual Field Analyzer.
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the amplitude of Visual Evoked Potentials (VEPs)
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, and at the 6-month follow-up
Change from baseline in the latency of Visual Evoked Potentials (VEPs)
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, and at the 6-month follow-up
Change from baseline in the connectivity of the Inferior Longitudinal Fasciculus
High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
Time frame: At baseline (at the beginning of the treatment) and at the end of the treatment
Change from baseline in the connectivity of the Superior Longitudinal Fasciculus
High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
Time frame: At baseline (at the beginning of the treatment) and at the end of the treatment
Change from baseline in the connectivity of the Inferior Fronto Occipital Fasciculus
High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
Time frame: At baseline (at the beginning of the treatment) and at the end of the treatment
Change from baseline in the connectivity of the Optic Radiations
High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
Time frame: At baseline (at the beginning of the treatment) and at the end of the treatment
Change from baseline in the connectivity of the Optic Tracts
High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
Time frame: At baseline (at the beginning of the treatment) and at the end of the treatment
Plan to share: Yes — Anonymized individual data will be made available on zenodo.com
Time frame: Data will become available right before the first submission of the first paper.
Access criteria: Upon request to l.diana@auxologico.it
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Istituto Auxologico Italiano →