Multisensory Telerehabilitation for Visual Field Defects

Not Applicable

Completed

• Conditions: Hemianopia; Brain Injuries; Visual Field Defect Following Cerebrovascular Accident
• Interventions: Behavioral: Audio-visual training (AVT) telerehabilitation

• Registration Number: NCT06341777
• Lead Sponsor: Istituto Auxologico Italiano

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-26
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Acquired homonymous visual field defect (HVFDs) due stroke, traumatic brain injury, tumor, surgery for epilepsy in a chronic stage of illness (time from the lesion >6 months)
• Normal hearing
• Normal or corrected-to-normal visual acuity

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Exclusion Criteria

• cognitive decline (adults)
• intellectual disability (children)
• major neurological or psychiatric disease
• being enrolled in another therapy for HVFDs

not being enrolled in another VFDs therapy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Intervention (IM group)	Audio-visual training (AVT) telerehabilitation	HVDFs patients who start the audio-visual telerehabilitation immediately
WaitList Delayed Intervention (WL group)	Audio-visual training (AVT) telerehabilitation	HVDFs patients waiting 1 month before receiving the audio-visual telerehabilitation.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Response Times (RTs) on the EF Task	At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups]	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.
Change from baseline in RTs on the Numbers Task	At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups	Computerized visual search task. Participants have to point to numbers (1 to 15) in ascending order. RTs: median search times (seconds).
Change from baseline in Accuracy on the EF Task	At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups]	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.
Change from baseline in RTs on the Triangle Task	At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups	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.
Change from baseline in Accuracy on the Triangle Task	At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups	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)
Change from baseline in omissions on the Bell Test (only children)	At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups	Participants have to cross out Bells (targets) among different distractors. Omissions: number of omitted targets.
Change from baseline in RTs on the Bell Test (only children)	At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups	Participants have to cross out Bells (targets) among different distractors. RTs: median search times (seconds).
Change from baseline in Accuracy on the Small Faces Test (only children)	At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups	Participants have to cross out targets among distractors. Accuracy: the number of correct responses
Change from baseline in RTs on the Small Faces Test (only children)	At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups	Participants have to cross out targets among distractors; RTs: median search times (seconds).

Secondary Outcome Measures

Name	Time	Method
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)	At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups	A scale assessing the presence of anxiety
Change from baseline in the Beck's Depression Inventory (BDI; total score; only adults)	At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups	A scale assessing the presence of depressive symptoms
Change from baseline in the Multidimensional Anxiety Scale for Children (MASC; total score; only children)	At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups	A scale assessing the presence of anxiety in children
Change from baseline in Daily Living Dependent on Vision Questionnaire (total score)	At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups	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")
Change from baseline in the Children Depression Inventory (CDI; total score; only children)	At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups	A scale assessing the presence of depressive symptoms in children
Change from baseline in the visual field size (only adults)	At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups	Automated Humphrey Visual Field Analyzer.
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	At baseline (at the beginning of the treatment) and at the end of the treatment	High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
Change from baseline in the connectivity of the Superior Longitudinal Fasciculus	At baseline (at the beginning of the treatment) and at the end of the treatment	High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
Change from baseline in the connectivity of the Inferior Fronto Occipital Fasciculus	At baseline (at the beginning of the treatment) and at the end of the treatment	High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
Change from baseline in the connectivity of the Optic Radiations	At baseline (at the beginning of the treatment) and at the end of the treatment	High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
Change from baseline in the connectivity of the Optic Tracts	At baseline (at the beginning of the treatment) and at the end of the treatment	High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity

Trial Locations

Locations (1)

Istituto Auxologico Italiano IRCCS; 🇮🇹 Milan, Lombardia, Italy