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| Name | Class |
|---|---|
| IRCCS Fondazione Stella Maris | OTHER |
| Meyer Children's Hospital IRCCS | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention (IM group) | Experimental | HVDFs patients who start the audio-visual telerehabilitation immediately |
|
| WaitList Delayed Intervention (WL group) | Experimental | HVDFs patients waiting 1 month before receiving the audio-visual telerehabilitation. |
|
| Healthy Participants | No Intervention | A group of 12 healthy participants is recruited for comparisons of MRI-based connectivity metrics |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audio-visual training (AVT) telerehabilitation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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) | 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. | 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). | At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups |
| Measure | Description | Time Frame |
|---|---|---|
| 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") | At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups |
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Inclusion Criteria:
Exclusion Criteria:
not being enrolled in another VFDs therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Auxologico Italiano IRCCS | Milan | Lombardy | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39994637 | Derived | Bolognini N, Diana L, Rossetti A, Melzi L, Basso G, Manzo V, Cruz-Sanabria F, Cammarata G, Cernigliaro F, Bianchi Marzoli S, Tinelli F, Fiori S, Casati C. Telerehabilitation for visual field defects with a multisensory training: a feasibility study. J Neuroeng Rehabil. 2025 Feb 24;22(1):34. doi: 10.1186/s12984-025-01573-4. |
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Anonymized individual data will be made available on zenodo.com
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Data will become available right before the first submission of the first paper.
Upon request to l.diana@auxologico.it
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| ID | Term |
|---|---|
| D006423 | Hemianopsia |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| 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. | 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). | 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 | 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). | 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) | 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 | 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 | 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 | 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 | 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. | 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) | 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) | 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 | 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 | 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 | 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 | 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 | At baseline (at the beginning of the treatment) and at the end of the treatment |
| D001766 |
| Blindness |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |