[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656534":3},{"organization":4,"outcomesModule":7,"designInfo":69,"detailedDescription":72,"studyPopulation":72,"armGroups":78,"interventions":94,"overallOfficials":103,"centralContacts":107,"locations":112,"responsibleParty":133,"collaborators":136,"id":140,"slug":141,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":72,"eligibilityCriteria":146,"healthyVolunteers":142,"sex":147,"minAge":148,"maxAge":149,"enrollmentInfo":150,"targetDuration":72,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":161,"overallStatus":115,"whyStopped":72,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"The Hong Kong Polytechnic University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":52},[9,13],{"measure":10,"description":11,"timeFrame":12},"General-health related quality of life","General health related quality of life will be measured using the Hong Kong version of the EuroQoL 5-Dimension instrument 5-level (EQ-5D-5L-HK). Five aspects will be meausred including mobility, self-care, usual activities, pain\u002Fdiscomport, anxiety\u002Fdepression. A scale of 1 to 5 will be rated. The participant will also be asked to give an overall score for their health at the time of measurement, which is out of 100, 0 means poorest","Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.",{"measure":14,"description":15,"timeFrame":12},"Vision-related quality of life","Vision-related quality of life will be measured by the Low Vision Visual Functioning Questionnaire 48 (LV VFQ-48). The LV VFQ48 was translated into Traditional Chinese. LV VFQ-48 measures the difficulties in performing daily activities.",[17,20,24,27,30,34,37,41,45,48],{"measure":18,"description":19,"timeFrame":12},"Visual function","Visual function will be measured using the Melbourne Low-Vision ADL Index (MLVAI). It includes 17 functional performance measures and 9 self-reported questions related to real-world daily activities. The original 17-item functional tasks in MLVAI were modified to align with the local context. Item descriptions were translated into Traditional Chinese. The scoring system has been revised to include quantifiable completion time to improve the reliability of performance scoring between assessors. Baseline assessment will collect two types of data: the original performance using habitual glasses and the performance score using a mobile phone (with any assistive functions enabled). The post-intervention assessment will collect performance scores using the advanced assistive technology prescribed to the participants during the intervention (i.e., smart glasses and\u002For an AI assistant on their mobile phone).",{"measure":21,"description":22,"timeFrame":23},"Level of hope (psychological wellbeing)","The level of hope is measured by the Herth Hope Index (HHI). This index includes 12 self-reported items, covering three subscales \"Sense of temporality and future\", \"Positive readiness and expectancy\", and \"Interconnectedness with self and others\". Each item is rated on a 4-point Likert scale, where 1 indicates strongly disagree, and 4 indicates strongly agree. The total score can range from 12 to 48. The higher the score, the greater the level of hope.","Changes from baseline and within one month after the completion of an eight-week intervention.",{"measure":25,"description":26,"timeFrame":12},"Depression severity (psychological wellbeing)","Depression severity is measured using the Patient Health Questionnaire (PHQ-9) . The PHQ-9 comprises nine questions, along with an impact question measuring the extent to which depressive symptoms affect daily functioning. Depression severity is measured over a two-week period. The frequency of the symptoms is rated on a four-point scale, where 0 = \"Not at all\", 1 = \"several days\", 2 = \"More than half of the days\", and 3 = \"Nearly every day\". The total score can range from 0 to 27. A higher PHQ-9 score indicates higher depressive severity. A cutoff score of 20 or above indicates severe depression.",{"measure":28,"description":29,"timeFrame":12},"Anxiety severity (Psychological wellbeing)","Severity of anxiety is assessed using the Generalised Anxiety Disorder-7 (GAD-7). GAD-7 includes seven questions along with one impact question. On a four-level scale, GAD-7 captures the frequency of anxiety symptoms experienced over the past two-week period. Each question is rated on a four-point scale, where 0 = \"Not at all\", 1 = \"Several days\", 2 = \"More than half the days\", 3 = \"Nearly every day\". The total score can range from 0 to 21. The higher the GAD-7 score, the higher the level of anxiety. A cutoff score of 15 or above indicates a severe level of anxiety.",{"measure":31,"description":32,"timeFrame":33},"Balance and mobility functions","Balance and mobility function will be measured using the Mini Balance Evaluation System Test (miniBesTest). This is a 14-item assessment. Each item is scored on a three-point ordinal scale, with 0 indicating severe impairment in performance, 1 indicating moderate impairment in performance, and 2 indicating normal performance. The 14 items cover anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. The highest possible score is 28, with a score of 21 or below indicating an elevated risk of falls. The performance of the miniBesTest is video-recorded.","Changes in measurement from Baseline to within one month after the completion of an eight-week intervention programme.",{"measure":35,"description":36,"timeFrame":12},"Mobility","The mobility function is assessed using the Narrow Path Walking Test (NPWT). The performance is scored based on the completion time (in seconds) taken to complete a six-metre-long path. A green mat measuring 40 x 300cm is used to divide a path into two 20-centimetre-wide pathways. The participants will be asked to stand up from a chair, walk around the green mat while avoiding stepping over the boundaries, and return to the chair at the starting point. Step errors are marked as those that step outside the boundaries. Three trials are allowed, and the average completion time will be used as final performance. The performance is video-recorded.",{"measure":38,"description":39,"timeFrame":40},"Lower body functioning","This will be assessed by the 30-second Chair Stand Test. The participant will be asked to sit fully on a chair and rise to a full standing position as many times as possible within 30 seconds. During the assessment, they are not allowed to use their hands for assistance. The assessor will count the number of repetitions a participant can complete within 30 seconds. Anyone who uses their hands to stand up will be scored a \"0\".","Changes in measurement from Baseline to within one month after completion of an eight-week intervention",{"measure":42,"description":43,"timeFrame":44},"Fear of fall","Fear of fall is assessed using the Chinese-validated version of the 16-item Fall Efficacy Scale International (FES-I). Each item is rated on a four-point Likert scale, where 1 indicates not concerned and 4 indicates extremely concerned. The total score can range from 16 to 84. The higher the FES-I score, the higher the fear of falls. A cutoff score of 28 or higher indicates a higher risk of falls.","Changes in measurement from baseline to within one month after the completion of an eight-week intervention.",{"measure":46,"description":47,"timeFrame":44},"Awareness of fall protective behaviour","This is assessed by the 30-item Fall Behavioural Scale (FaB). Each item is rated on a four-level Likert scale, with 1 = \"never\", 2 = \"sometimes\", 3 = \"often\", 4 = \"always\", and an option of \"not applicable\". The higher the FaB score, the higher the use of protective behaviours.",{"measure":49,"description":50,"timeFrame":51},"Environmental fall hazards (home environement)","Fall hazard in home environment is assessed by the WestMead Home Safety Assessment (WeHSA). The WeHSA assessed a total of 72-item hazard categories across 13 areas at home, where applicable. The outcome measure is the number of hazards identified across these 13 areas.","Changes in measurement from baseline to within one month after the completion of an eight-week intervention",[53,57,61,65],{"measure":54,"description":55,"timeFrame":56},"fall incidence","The number of falls in the past 12 months, fall characteristics and consquences will be collected","This outcome will be collected at baseline, within one month after completion of intervention, 3-month post intervention, 6-month post intervention, 9-month post intervention and 12-month post intervention.",{"measure":58,"description":59,"timeFrame":60},"advanced assistive technology adoption rate","The adoption rate is the proportion of people who are introduced to an advanced assistive device and agree to use the device during the intervention period. A binary outcome will be collected, i.e. yes\u002F no.","The measurement will be taken at baseline.",{"measure":62,"description":63,"timeFrame":64},"advanced assistive technology continuation rate","The continuation rate of the intervention components will be recorded as a binary outcome, i.e. yes or no. We collect whether the participant continue to engage in execise training, use of AI glassess\u002F smartphone accessibility, after intervention period.","Outcome measurement collected at 3 months post intervention, 6 month post intervention, and 12 month post intervention.",{"measure":66,"description":67,"timeFrame":68},"User satisfaction of assistive tehcnology","This will be assessed using the Chinese version of the Quebec User Evaluation of Satisfaction with Assistive Technology (C-QUEST). This survey has 12 statements focusing on the device domain (Dimension, weight, adjustment, safety, durability, simplicity of use, comfort, and effectiveness) and the service domain (delivery service, repair\u002Fservicing, professional service, and follow-up service). Each statement is rated on a scale from 1 to 5, with 1 = \"not satisfied at all\" to 5 = \"very satisfied\". The questionnaire will yield three scores: the sub-scores for the device and service domains, and the total C-QUEST score. The CQUEST score can range from 12 to 60. The higher the CQUEST score, the higher the satisfaction towards the prescribed assistive technology. Each participant is also required to identify the three most important items out of the 12 items.","The outcome will be collected in the 4th week of the intervention period and within one month after the completion of the eight-week intervention.",{"allocation":70,"interventionModel":71,"interventionModelDescription":72,"primaryPurpose":73,"observationalModel":72,"timePerspective":72,"maskingInfo":74},"RANDOMIZED","PARALLEL",null,"HEALTH_SERVICES_RESEARCH",{"masking":75,"maskingDescription":72,"whoMasked":76},"SINGLE",[77],"OUTCOMES_ASSESSOR",[79,83,89],{"label":80,"type":81,"description":82,"interventionNames":72},"Control waitlist","NO_INTERVENTION","Participants will wait for 3 months before receiving intervention",{"label":84,"type":85,"description":86,"interventionNames":87},"Vision rehabilitation arm","EXPERIMENTAL","Participants assigned to the Vision rehabilitation arm will only receive the low vision training on the use of advanced assistive technology. Group-based training will be provided.",[88],"Other: Vision rehabilitation incorporating low vision training only",{"label":90,"type":85,"description":91,"interventionNames":92},"Multidisciplinary vision rehabilitation","Multidisciplinary vision rehabilitation includes group-based low-vision training, group-based solution-focused therapy, group-based exercise training, and home assessment with home modification (if needed).",[93],"Other: Multidisciplinary vision rehabilitaion",[95,99],{"type":6,"name":96,"description":97,"armGroupLabels":98,"otherNames":72},"Multidisciplinary vision rehabilitaion","A holistic approach to provide vision rehabilitation services, including low vision training incorporating advanced assistive technology, home-based exercise training, counselling and home assessment with home modification. The intervention lasts for eight weeks. On-site, group-based training sessions are provided for low vision training (1 hour), exercise training (1 hour), and solution-focused therapy (1.5 hours). Low vision training components are identical to the components received in the vision rehabilitation (low vision component) arm. Exercise training focuses on strengthening lower-limb muscles designed to reduce risk of falls. Solution-focused therapy focuses on helping participants build solutions to visual impairment problems and facilitate their development of preferred futures. Participants will receive minor home modifications, if needed, after the home assessment.",[90],{"type":6,"name":100,"description":101,"armGroupLabels":102,"otherNames":72},"Vision rehabilitation incorporating low vision training only","This intervention includes providing vision rehabilitation that incorporates advanced assistive technology to support daily living. The intervention lasts for eight weeks, which includes four on-site training sessions (1 hour each). The group-based training includes an introduction to operating smart glasses and AI assistant applications on mobile devices, and offers scenario-based training on utilising these advanced assistive technologies to perform daily activities.",[84],[104],{"name":105,"affiliation":5,"role":106},"Ming-Yan Allen Cheong, PhD","PRINCIPAL_INVESTIGATOR",[108],{"name":105,"role":109,"phone":110,"phoneExt":72,"email":111},"CONTACT","+852 2766 6108","allen.my.cheong@polyu.edu.hk",[113],{"facility":114,"status":115,"city":116,"state":117,"zip":72,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":125,"contacts":126},"School of Optometry, The Hong Kong Polytechnic University","RECRUITING","Kowloon","Hung Hom","Hong Kong","HK",{"type":121,"coordinates":122},"Point",[123,124],114.18333,22.31667,{"lat":124,"lon":123},[127,128,132],{"name":105,"role":109,"phone":110,"phoneExt":72,"email":111},{"name":129,"role":109,"phone":130,"phoneExt":72,"email":131},"Wing Yan Lau, PhD","+852 2766 4462","ingrid.lau@polyu.edu.hk",{"name":105,"role":106,"phone":72,"phoneExt":72,"email":72},{"type":106,"investigatorFullName":134,"investigatorTitle":135,"investigatorAffiliation":5,"oldNameTitle":72,"oldOrganization":72},"Allen MY Cheong","Professor",[137],{"name":138,"class":139},"Wu Jieh Yee Charitable Foundation","UNKNOWN","100656534","effectiveness-of-a-multi-disciplinary-vision-rehabilitation-programme-in-improving-the-overall-quality-of-life-of-visually-impaired-adults-100656534",false,"NCT07827040","Effectiveness of a Multi-disciplinary Vision Rehabilitation Programme in Improving the Overall Quality of Life of Visually Impaired Adults","Effectiveness of a Multi-disciplinary Vision Rehabilitation Programme in Improving Function and Quality of Life of Visually Impaired Patients: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 18 and 80 years\n* Community-dwelling in Hong Kong\n* Cantonese Speaker\n* Clinical diagnosis of low vision (best-corrected visual acuity \\\u003C6\u002F18; and\u002For field loss of \\\u003C 20 degree)\n* Stable ocular condition for ≥ 3 months\n* Owns a smartphone\n* Not currently participating in any vision rehabilitation programme\n* Willing to participate and commit for at least 6 months to 12 months\n* Provides informed consent\n\nExclusion Criteria:\n\n* Living in a nursing home\u002F institutionalized\n* Self-reported severe cognitive impairment or HK-MoCA-VI cut off score of 12\n* Self-reported severe hearing impairment\n* Uncontrolled systemic ocular diseases\u002F neurological or psychiatric conditions\n* Immobility caused by physical impairment\n* Refuse to provide written informed consent\n* Participating in another vision rehabilitation programme during the trial period","ALL","18 Years","80 Years",{"count":151,"type":152},1000,"ESTIMATED","INTERVENTIONAL",[155],"NA","This trial compares multidisciplinary vision rehabilitation and vision rehabilitation services to determine which service works better at improving overall quality of life for adults with visual impairment. Before receiving the intervention, participants will complete baseline measurements, including an eye examination, cognitive and hearing screenings, mobility and balance assessments, questionnaires on basic demographics and health, and a home environment assessment. This randomised controlled trial includes three arms: 1) control-waitlist (wait for 3 months before joining either intervention arm), 2) vision rehabilitation with low vision training only, and 3) multidisciplinary vision rehabilitation arm.\n\nThe intervention period lasts for eight weeks, comprising of four on-site training sessions.\n\n* During the intervention period, all participants will receive low-vision training on the use of advanced assistive technology.\n* Those in the multidisciplinary group will also receive counselling, exercise training, and home assessment with home modifications (if needed).",[158,159,160],"Visual Impairments","Low Vision Digital Assistance","Adults",[162,163,164],"low vision","advanced assistive technology","vision rehabilitation","2026-09-12",{"date":167,"type":168},"2026-09-18","ACTUAL",{"date":170,"type":152},"2026-09-29",{"date":172,"type":152},"2029-09-30",{"name":5,"class":6},1]