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.
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.
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.
Single group
Individualized Neurovisual Rehabilitation
BehavioralIndividualized 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.
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.
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.
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.
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.
Change in visual field findings assessed by Damato campimetry
Change from baseline in central visual field findings assessed using the Damato 30-Point Multifixation Campimeter included in the Brain Injury Visual Assessment Battery for Adults (biVABA). At each tested visual field location, failure to detect the presented target will be recorded on the visual field diagram according to the standardized biVABA procedure. Baseline and post-intervention visual field findings will be compared with respect to the location and extent of missed target locations and the resulting visual field deficit pattern. No composite visual field score will be calculated.
Uptake of the neurovisual rehabilitation study
Proportion of individuals who meet the eligibility criteria for the interventional study and consent to participate. Uptake will be calculated as the number of eligible individuals who provide informed consent and enroll in the interventional study divided by the total number of eligible individuals invited to participate.
Attendance at therapist-led rehabilitation sessions
Number of individual therapist-led neurovisual rehabilitation sessions attended by each participant out of the five planned sessions. Attendance will be reported as the number of sessions attended and as the proportion of the five planned therapist-led sessions completed by each participant.
Adherence to prescribed self-training
Adherence to individually prescribed self-training during the neurovisual rehabilitation program. Participants will be instructed to perform self-training at least 5 days per week between the first and final therapist-led rehabilitation sessions. Adherence will be calculated for each participant as the number of self-training days reported as completed divided by the number of self-training days prescribed, expressed as a percentage.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
