Brain InjuriesNCT07849582
Pilot Study of Individualized Neurovisual Rehabilitation Following Acquired Brain Injury
A study testing Individualized Neurovisual Rehabilitation in people with Brain Injuries, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Individualized Neurovisual Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Oct 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
General University Hospital in Prague, U Nemocnice 499/2
Prague, 128 08
Anna Rejtarová, 603460685, anneinez@gmail.com
anneinez@gmail.com
About this study
Official title: Feasibility and Preliminary Outcomes of Individualized Neurovisual Rehabilitation Following Acquired Brain Injury: A Prospective Single-Group Pilot Study
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.
Read more
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.
Read the detailed description
Visual impairment following acquired brain injury may include oculomotor dysfunction, impaired visual attention and scanning, visual field loss, and other visual deficits that interfere with daily activities, mobility, and participation. Neurovisual rehabilitation may include restorative and compensatory approaches tailored to the individual's identified visual impairment and functional difficulties.
This prospective single-group pilot study will evaluate the feasibility and preliminary outcomes of an individualized neurovisual rehabilitation program in 30 adults with visual impairment following acquired brain injury.
Eligible participants will have at least one acquired visual impairment identified through standardized visual assessment and considered amenable to rehabilitation. Potential rehabilitation targets may include impaired fixation, smooth pursuit, saccadic eye movements, vergence, gaze stabilization, visual scanning and search, visual attention, and compensatory strategies for acquired visual field loss.
The intervention will consist of five individual therapist-led rehabilitation sessions, planned approximately once weekly. The period from the first to the final therapist-led session may extend to a maximum of 8 weeks to accommodate illness, scheduling difficulties, or other practical circumstances.
Treatment will be individualized according to the participant's identified visual impairment and functional difficulties. 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.
Intervention completion will be defined as completion of at least four of the five planned therapist-led sessions within 8 weeks. Full intervention completion will be defined as completion of all five sessions within this period.
The post-intervention assessment will be performed within 7 days after the participant's final completed therapist-led rehabilitation session, once the intervention period has been completed or discontinued.
The primary purpose of this pilot study is to evaluate feasibility. Feasibility outcomes will include intervention uptake, attendance, intervention 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 also be explored. Because this is an uncontrolled pilot study, analyses of clinical outcomes are exploratory and are not intended to provide definitive evidence of treatment efficacy.
- Conditions
- Brain Injuries
- Being tested
- Individualized Neurovisual Rehabilitation
- Keywords
- acquired brain injury, visual impairment, neurovisual rehabilitation, oculomotor dysfunction, visual attention, visual field impairment, occupational therapy
- Medical subject headings
- Brain Injuries, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Neurovisual RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Individualized Neurovisual Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Change from baseline in self-reported functional visual performance assessed using the Revised Self-Report Assessment of Functional Visual Performance (R-SRAFVP).
The R-SRAFVP consists of 33 items assessing vision-dependent daily activities. Applicable items are rated on a 5-point scale from 0 (unable; dependent on others to perform the task) to 4 (independent; no difficulty performing the task safely, accurately, and efficiently). Items that are not applicable to the participant may be rated as not applicable (NA).
The R-SRAFVP score calculated according to the standardized scoring procedure will be used for the pre-post comparison. Higher item ratings indicate greater independence and less difficulty in performing vision-dependent daily activities.
Measured: Baseline and within 7 days after the participant's final completed therapist-led rehabilitation session
Change in visual attention and scanning performance
Change from baseline in visual attention and visual scanning performance, assessed using selected visual search subtests of the Brain Injury Visual Assessment Battery for Adults (biVABA).
The same selected subtests will be administered at baseline and post-intervention. Performance will be evaluated using task-specific measures, including percentage of correct responses, completion time in seconds, and organization of the visual search strategy, as applicable to the respective subtest.
At least one structured and one unstructured visual search subtest will be used for repeated assessment. Outcomes for individual subtests and performance parameters will be evaluated separately; no composite biVABA visual attention score will be calculated.
Measured: Baseline and within 7 days after the participant's final completed therapist-led rehabilitation session
Change in oculomotor function
Change from baseline in oculomotor findings assessed using the oculomotor assessments of the Brain Injury Visual Assessment Battery for Adults (biVABA).
The assessment will include fixation, smooth pursuit, saccadic eye movements, ocular alignment, and vergence, as applicable to the participant. Pre-post changes will be evaluated separately for the oculomotor functions assessed using the findings and performance criteria specified for the respective biVABA assessments.
No composite oculomotor score will be calculated.
Measured: Baseline and within 7 days after the participant's final completed therapist-led rehabilitation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion18 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Rejtarová, Principal investigator, Charles University, First & 2nd faculty of medicine, General faculty hospital in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849582
- Sponsor's protocol ID
- 506225 - INT
- Other IDs
- 506225 GAUK
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be made publicly available or shared with other researchers. Study results will be disseminated in aggregated and de-identified form through scientific publications and presentations. No individual participant data sharing plan has been established for this study.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Outcomes of Individualized Neurovisual Rehabilitation Following Acquired Brain Injury: A Prospective Single-Group Pilot Study
- ClinicalTrials.gov ID
- NCT07849582
- Acronym / sponsor ID
- 506225 - INT
- Conditions
- Brain Injuries
- Keywords
- acquired brain injury, visual impairment, neurovisual rehabilitation, oculomotor dysfunction, visual attention, visual field impairment, occupational therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 18 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Visual impairment following acquired brain injury may include oculomotor dysfunction, impaired visual attention and scanning, visual field loss, and other visual deficits that interfere with daily activities, mobility, and participation. Neurovisual rehabilitation may include restorative and compensatory approaches tailored to the individual's identified visual impairment and functional difficulties.
This prospective single-group pilot study will evaluate the feasibility and preliminary outcomes of an individualized neurovisual rehabilitation program in 30 adults with visual impairment following acquired brain injury.
Eligible participants will have at least one acquired visual impairment identified through standardized visual assessment and considered amenable to rehabilitation. Potential rehabilitation targets may include impaired fixation, smooth pursuit, saccadic eye movements, vergence, gaze stabilization, visual scanning and search, visual attention, and compensatory strategies for acquired visual field loss.
The intervention will consist of five individual therapist-led rehabilitation sessions, planned approximately once weekly. The period from the first to the final therapist-led session may extend to a maximum of 8 weeks to accommodate illness, scheduling difficulties, or other practical circumstances.
Treatment will be individualized according to the participant's identified visual impairment and functional difficulties. 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.
Intervention completion will be defined as completion of at least four of the five planned therapist-led sessions within 8 weeks. Full intervention completion will be defined as completion of all five sessions within this period.
The post-intervention assessment will be performed within 7 days after the participant's final completed therapist-led rehabilitation session, once the intervention period has been completed or discontinued.
The primary purpose of this pilot study is to evaluate feasibility. Feasibility outcomes will include intervention uptake, attendance, intervention 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 also be explored. Because this is an uncontrolled pilot study, analyses of clinical outcomes are exploratory and are not intended to provide definitive evidence of treatment efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Individualized Neurovisual Rehabilitation | Experimental | Behavioral: Individualized Neurovisual RehabilitationParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Neurovisual RehabilitationIndividualized 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. | Behavioural | Individualized Neurovisual Rehabilitation |
Primary outcome
Intervention completion
Time frame: From the first therapist-led rehabilitation session through 8 weeks
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.
3 secondary outcomes
Change in self-reported functional visual performance measured by the R-SRAFVP
Time frame: Baseline and within 7 days after the participant's final completed therapist-led rehabilitation session
Change in visual attention and scanning performance
Time frame: Baseline and within 7 days after the participant's final completed therapist-led rehabilitation session
Change in oculomotor function
Time frame: Baseline and within 7 days after the participant's final completed therapist-led rehabilitation session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be made publicly available or shared with other researchers. Study results will be disseminated in aggregated and de-identified form through scientific publications and presentations. No individual participant data sharing plan has been established for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Rejtarová principal investigator
Charles University, First & 2nd faculty of medicine, General faculty hospital in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Neurovisual Rehabilitation in people with Brain Injuries, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Rejtarová (+420603460685, anneinez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention completion (time frame: From the first therapist-led rehabilitation session through 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.