Multisensory Telerehabilitation for Visual Field Defects

NCT ID: NCT06341777

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Immediate Intervention (IM group)

HVDFs patients who start the audio-visual telerehabilitation immediately

Group Type: EXPERIMENTAL

Audio-visual training (AVT) telerehabilitation

Intervention Type: 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.

WaitList Delayed Intervention (WL group)

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

Group Type: EXPERIMENTAL

Audio-visual training (AVT) telerehabilitation

Intervention Type: 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.

Healthy Participants

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Audio-visual training (AVT) telerehabilitation

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Fondazione Stella Maris

OTHER

Sponsor Role: collaborator

Meyer Children's Hospital IRCCS

OTHER

Sponsor Role: collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Auxologico Italiano IRCCS

Milan, Lombardy, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 39994637 (View on PubMed)

Other Identifiers

25M621

Identifier Type: -

Identifier Source: org_study_id