[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658378":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":51,"studyPopulation":48,"armGroups":52,"interventions":59,"overallOfficials":64,"centralContacts":69,"locations":74,"responsibleParty":91,"collaborators":48,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":48,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":48,"studyType":106,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":119,"whyStopped":48,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Charles University, Czech Republic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"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.\n\nIntervention 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.\n\nThe 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",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"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).\n\nThe 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).\n\nThe 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.","Baseline and within 7 days after the participant's final completed therapist-led rehabilitation session",{"measure":19,"description":20,"timeFrame":17},"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).\n\nThe 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.\n\nAt 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.",{"measure":22,"description":23,"timeFrame":17},"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).\n\nThe 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.\n\nNo composite oculomotor score will be calculated.",[25,28,32,35,39],{"measure":26,"description":27,"timeFrame":17},"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).\n\nAt 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.\n\nNo composite visual field score will be calculated.",{"measure":29,"description":30,"timeFrame":31},"Uptake of the neurovisual rehabilitation study","Proportion of individuals who meet the eligibility criteria for the interventional study and consent to participate.\n\nUptake 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.","From determination of eligibility through enrollment in the interventional study",{"measure":33,"description":34,"timeFrame":12},"Attendance at therapist-led rehabilitation sessions","Number of individual therapist-led neurovisual rehabilitation sessions attended by each participant out of the five planned sessions.\n\nAttendance will be reported as the number of sessions attended and as the proportion of the five planned therapist-led sessions completed by each participant.",{"measure":36,"description":37,"timeFrame":38},"Adherence to prescribed self-training","Adherence to individually prescribed self-training during the neurovisual rehabilitation program.\n\nParticipants will be instructed to perform self-training at least 5 days per week between the first and final therapist-led rehabilitation sessions.\n\nAdherence 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.","From the first through the final therapist-led rehabilitation session, up to 8 weeks",{"measure":40,"description":41,"timeFrame":42},"Completion of post-intervention assessment","Proportion of enrolled participants who complete the planned post-intervention assessment.\n\nThe 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.\n\nThe outcome will be reported as the number and proportion of enrolled participants who complete the post-intervention assessment within the specified time frame.","From enrollment through completion of the post-intervention assessment",{"allocation":44,"interventionModel":45,"interventionModelDescription":46,"primaryPurpose":47,"observationalModel":48,"timePerspective":48,"maskingInfo":49},"NA","SINGLE_GROUP","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.","TREATMENT",null,{"masking":50,"maskingDescription":48,"whoMasked":48},"NONE","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.\n\nThis 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.\n\nEligible 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.\n\nThe 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.\n\nTreatment 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.\n\nIntervention 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.\n\nThe 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.\n\nThe 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.",[53],{"label":54,"type":55,"description":56,"interventionNames":57},"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.",[58],"Behavioral: Individualized Neurovisual Rehabilitation",[60],{"type":61,"name":54,"description":62,"armGroupLabels":63,"otherNames":48},"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.\n\nTreatment 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.\n\nParticipants 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.",[54],[65],{"name":66,"affiliation":67,"role":68},"Anna Rejtarová","Charles University, First & 2nd faculty of medicine, General faculty hospital in Prague","PRINCIPAL_INVESTIGATOR",[70],{"name":66,"role":71,"phone":72,"phoneExt":48,"email":73},"CONTACT","+420603460685","anneinez@gmail.com",[75],{"facility":76,"status":48,"city":77,"state":48,"zip":78,"country":79,"countryCode":48,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"General University Hospital in Prague, U Nemocnice 499\u002F2","Prague","128 08","Czechia",{"type":81,"coordinates":82},"Point",[83,84],14.42076,50.08804,{"lat":84,"lon":83},[87,89,90],{"name":66,"role":71,"phone":88,"phoneExt":48,"email":73},"603460685",{"name":48,"role":71,"phone":48,"phoneExt":48,"email":73},{"name":66,"role":68,"phone":48,"phoneExt":48,"email":48},{"type":92,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100658378","pilot-study-of-individualized-neurovisual-rehabilitation-following-acquired-brain-injury-100658378",false,"NCT07849582","Pilot Study of Individualized Neurovisual Rehabilitation Following Acquired Brain Injury","Feasibility and Preliminary Outcomes of Individualized Neurovisual Rehabilitation Following Acquired Brain Injury: A Prospective Single-Group Pilot Study","Inclusion Criteria:\n\n* Age 18 to 85 years.\n* Diagnosis of acquired brain injury, including stroke, traumatic brain injury, or brain tumor.\n* 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.\n* Presence of at least one acquired visual impairment identified through standardized visual assessment and considered amenable to the planned neurovisual rehabilitation.\n* 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.\n* Sufficient ability to understand therapeutic instructions and cooperate with the study assessments and rehabilitation program.\n* Sufficient ability to communicate in Czech to understand therapeutic instructions and report visual difficulties.\n* Ability to participate regularly in the planned rehabilitation program and prescribed self-training.\n* Written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Congenital visual impairment.\n* 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.\n* 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.\n* Visual impairment not considered amenable to the planned neurovisual - rehabilitation approach.\n\nInability to complete the study assessments or participate in the rehabilitation program because of severe cognitive, communication, behavioral, or medical limitations.","ALL","18 Years","85 Years",{"count":104,"type":105},30,"ESTIMATED","INTERVENTIONAL",[44],"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.\n\nThirty 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.\n\nFeasibility 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.\n\nBecause the study has no control group, analyses of clinical outcomes will be exploratory and are not intended to provide definitive evidence of treatment efficacy.",[110],"Brain Injuries",[112,113,114,115,116,117,118],"acquired brain injury","visual impairment","neurovisual rehabilitation","oculomotor dysfunction","visual attention","visual field impairment","occupational therapy","NOT_YET_RECRUITING","2026-09-24",{"date":122,"type":123},"2026-09-30","ACTUAL",{"date":125,"type":105},"2026-10-15",{"date":127,"type":105},"2028-03-01",{"name":5,"class":6},1]