Clinical trial NCT06341777: Multisensory Telerehabilitation for Visual Field Defects
Official title: Telerehabilitation for Visual Field Defects: Clinical Efficacy of a Novel Multisensory Therapy for Adults and Children With Acquired Brain Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Field Defect Following Cerebrovascular Accident
Hemianopia
Brain Injuries
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: IRCCS Fondazione Stella Maris
name: Meyer Children's Hospital IRCCS
First posted: 2024-04-02
Enrollment: 72
Sex: ALL
Minimum age (years): 6
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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.

Primary outcomes:
measure: Change from baseline in Accuracy on the EF Task
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups]
measure: Change from baseline in Response Times (RTs) on the EF Task
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups]
measure: Change from baseline in Accuracy on the Triangle Task
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
measure: Change from baseline in RTs on the Triangle Task
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
measure: Change from baseline in RTs on the Numbers Task
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
measure: Change from baseline in omissions on the Bell Test (only children)
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
measure: Change from baseline in RTs on the Bell Test (only children)
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
measure: Change from baseline in Accuracy on the Small Faces Test (only children)
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
measure: Change from baseline in RTs on the Small Faces Test (only children)
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Secondary outcomes:
measure: Change from baseline in Daily Living Dependent on Vision Questionnaire (total score)
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
measure: Change from baseline in the Reading test (reading time)
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
measure: Change from baseline in the Hamilton Anxiety Scale (total score; only adults)
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
measure: Change from baseline in the Beck's Depression Inventory (BDI; total score; only adults)
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
measure: Change from baseline in the Multidimensional Anxiety Scale for Children (MASC; total score; only children)
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
measure: Change from baseline in the Children Depression Inventory (CDI; total score; only children)
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
measure: Change from baseline in the visual field size (only adults)
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
measure: Change from baseline in the amplitude of Visual Evoked Potentials (VEPs)
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, and at the 6-month follow-up
measure: Change from baseline in the latency of Visual Evoked Potentials (VEPs)
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, and at the 6-month follow-up
measure: Change from baseline in the connectivity of the Inferior Longitudinal Fasciculus
timeFrame: At baseline (at the beginning of the treatment) and at the end of the treatment
measure: Change from baseline in the connectivity of the Superior Longitudinal Fasciculus
timeFrame: At baseline (at the beginning of the treatment) and at the end of the treatment
measure: Change from baseline in the connectivity of the Inferior Fronto Occipital Fasciculus
timeFrame: At baseline (at the beginning of the treatment) and at the end of the treatment
measure: Change from baseline in the connectivity of the Optic Radiations
timeFrame: At baseline (at the beginning of the treatment) and at the end of the treatment
measure: Change from baseline in the connectivity of the Optic Tracts
timeFrame: At baseline (at the beginning of the treatment) and at the end of the treatment
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano IRCCS
state: Lombardia
Study officials:
References: