Multisensory Telerehabilitation for Visual Field Defects

NCT06341777 | Completed

• 1 other identifier: 25M621
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Field Defect Following Cerebrovascular Accident; Hemianopia; Brain Injuries

Outcome Measures

Primary Outcomes (9)

• 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

• 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

Secondary Outcomes (14)

• 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

• 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

• 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

• 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

Study Arms (3)

Immediate Intervention (IM group)

EXPERIMENTAL

HVDFs patients who start the audio-visual telerehabilitation immediately

Behavioral: Audio-visual training (AVT) telerehabilitation

WaitList Delayed Intervention (WL group)

EXPERIMENTAL

HVDFs patients waiting 1 month before receiving the audio-visual telerehabilitation.

Behavioral: Audio-visual training (AVT) telerehabilitation

Healthy Participants

NO INTERVENTION

A group of 12 healthy participants is recruited for comparisons of MRI-based connectivity metrics

Interventions

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.

Immediate Intervention (IM group); WaitList Delayed Intervention (WL group)

Eligibility Criteria

• Age: 6 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• IRCCS Fondazione Stella Maris: collaborator
• Meyer Children's Hospital IRCCS: collaborator

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, Lombardy, 20122, Italy

Location

Related Publications (1)

• 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.

  PMID: 39994637 DERIVED

MeSH Terms

Conditions

Hemianopsia; Brain Injuries

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 2, 2024
• Study Start: January 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available right before the first submission of the first paper.
• Access Criteria: Upon request to l.diana@auxologico.it

Locations

IT (1)