Pilot Study of Individualized Neurovisual Rehabilitation Following Acquired Brain Injury

NCT07849582 | Not Yet Recruiting

• 2 other identifiers: 506225 - INT506225 GAUK
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective single-group pilot study will evaluate the feasibility and preliminary outcomes of an individualized neurovisual rehabilitation program for adults with visual impairment following acquired brain injury. Thirty participants will receive five individual therapist-led rehabilitation sessions together with individually prescribed self-training. The rehabilitation program will be tailored to each participant's identified visual impairment and functional difficulties. Feasibility will be evaluated through intervention uptake, attendance, completion, adherence to prescribed self-training, and completion of post-intervention assessment. Preliminary changes in self-reported visual functioning and selected objective measures of visual function will be assessed from baseline to post-intervention. Because the study has no control group, analyses of clinical outcomes will be exploratory and are not intended to provide definitive evidence of treatment efficacy.

Conditions

Brain Injuries

Keywords

acquired brain injury; visual impairment; neurovisual rehabilitation; oculomotor dysfunction; visual attention; visual field impairment; occupational therapy

Outcome Measures

Primary Outcomes (1)

• Intervention completion

  Proportion of participants who complete at least four of the five planned individual therapist-led neurovisual rehabilitation sessions within a maximum period of 8 weeks from the first therapist-led session. Intervention completion is defined as attendance at at least four of the five planned therapist-led sessions within this period. Completion of all five planned sessions within 8 weeks will additionally be recorded as full intervention completion. The outcome will be reported as the number and proportion of enrolled participants meeting the intervention completion criterion.

  From the first therapist-led rehabilitation session through 8 weeks

Secondary Outcomes (3)

• Change in self-reported functional visual performance measured by the R-SRAFVP

  Baseline and within 7 days after the participant's final completed therapist-led rehabilitation session

• Change in visual attention and scanning performance

  Baseline and within 7 days after the participant's final completed therapist-led rehabilitation session

• Change in oculomotor function

  Baseline and within 7 days after the participant's final completed therapist-led rehabilitation session

Other Outcomes (5)

• Change in visual field findings assessed by Damato campimetry

  Baseline and within 7 days after the participant's final completed therapist-led rehabilitation session

• Uptake of the neurovisual rehabilitation study

  From determination of eligibility through enrollment in the interventional study

• Attendance at therapist-led rehabilitation sessions

  From the first therapist-led rehabilitation session through 8 weeks

Study Arms (1)

Individualized Neurovisual Rehabilitation

EXPERIMENTAL

Participants will receive an individualized neurovisual rehabilitation program consisting of five individual therapist-led rehabilitation sessions together with individually prescribed self-training. Rehabilitation content will be selected according to each participant's identified visual impairment and functional difficulties.

Behavioral: Individualized Neurovisual Rehabilitation

Interventions

Individualized Neurovisual Rehabilitation BEHAVIORAL

Individualized neurovisual rehabilitation will be delivered in five individual therapist-led sessions, planned approximately once weekly and completed within a maximum period of 8 weeks from the first therapist-led session. Treatment content will be selected according to each participant's identified visual impairment and functional difficulties and may include training of fixation, smooth pursuit, saccadic eye movements, vergence, gaze stabilization, visual scanning and search, visual attention, and compensatory strategies for acquired visual field loss. Participants will additionally receive individually prescribed self-training and will be instructed to perform self-training on at least 5 days per week between the first and final therapist-led rehabilitation sessions.

Individualized Neurovisual Rehabilitation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 85 years.
• Diagnosis of acquired brain injury, including stroke, traumatic brain injury, or brain tumor.
• Enrollment between 4 weeks and 12 months after the relevant index event. The index event is defined as stroke onset for participants with stroke, date of injury for participants with traumatic brain injury, and diagnosis or treatment-related event associated with the onset of the acquired visual or neurological impairment for participants with a brain tumor.
• Presence of at least one acquired visual impairment identified through standardized visual assessment and considered amenable to the planned neurovisual rehabilitation.
• Sufficient cognitive ability to participate in the study assessments and rehabilitation program, defined as a Montreal Cognitive Assessment-Blind (MoCA-Blind) score greater than 10.
• Sufficient ability to understand therapeutic instructions and cooperate with the study assessments and rehabilitation program.
• Sufficient ability to communicate in Czech to understand therapeutic instructions and report visual difficulties.
• Ability to participate regularly in the planned rehabilitation program and prescribed self-training.
• Written informed consent to participate in the study.

You may not qualify if:

• Congenital visual impairment.
• Pre-existing visual impairment or eye disease that was present before the acquired brain injury and could substantially interfere with the assessment or rehabilitation of visual impairment associated with the acquired brain injury.
• Long-term metabolic disease with known visual complications that could substantially interfere with the assessment or rehabilitation of visual impairment associated with the acquired brain injury.
• Visual impairment not considered amenable to the planned neurovisual - rehabilitation approach.
• Inability to complete the study assessments or participate in the rehabilitation program because of severe cognitive, communication, behavioral, or medical limitations.

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

General University Hospital in Prague, U Nemocnice 499/2

Prague, 128 08, Czechia

Location

MeSH Terms

Conditions

Brain Injuries; Vision Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Anna Rejtarová

  Charles University, First & 2nd faculty of medicine, General faculty hospital in Prague

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Rejtarová

CONTACT

+420603460685; anneinez@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive the same individualized neurovisual rehabilitation program. The specific therapeutic content will be tailored to the visual impairment and functional difficulties identified in each participant.

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): December 18, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)