[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583593":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":25,"responsibleParty":32,"collaborators":25,"id":34,"slug":25,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":37,"acronym":25,"eligibilityCriteria":38,"healthyVolunteers":35,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":25,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":55,"whyStopped":25,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":25},{"fullName":5,"class":6},"The Hong Kong Polytechnic University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"a home-based, social robot-assisted intervention (SRAI) for older adults with hearing loss","EXPERIMENTAL","This study will feature a 2 kg, 30 cm tall and 20 cm wide, Cantonese-speaking humanoid social robot named KaKa.",[13],"Behavioral: A social robot KaKa-assisted intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"control group","ACTIVE_COMPARATOR","physical activity at the same intensity level and frequency as the IG without a robot.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","A social robot KaKa-assisted intervention","A social robot KaKa-assisted intervention (SRAI) to provide auditory rehabilitation and physical activity program",[9,15],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Ivy Zhao, PhD","CONTACT","+8527664550","yan-ivy.zhao@polyu.edu.hk",{"type":33,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100583593",false,"NCT06878339","Increasing Physical Activity with a Social Robot-assisted Exercise Intervention in Older Adults with Hearing Loss: a Feasibility and Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n1. ethnic Chinese aged ≥65 years old living at home;\n2. with mild to moderate HL with a pure-tone average of 20 to 50 dB across octave frequencies 0.5 to 4kHz in both ears;\n3. no cognitive impairment \\[score of ≦2 on the 5-item Abbreviated Memory Inventory for the Chinese (AMIC)\\]; and\n4. informed consent to participate in this study. Loneliness is not a pre-requisite for taking part in the research. Nevertheless, previous findings from a longitudinal cohort study indicate that approximately 46.6% of older adults with hearing loss reported feeling lonely.\n\nExclusion Criteria:\n\n1. those with a diagnosis of a major neurocognitive disorder;\n2. a history of symptomatic stroke or other disease of the central nervous system;\n3. a serious medical or psychiatric illness (e.g., severe depression, schizophrenia, bi-polar disorder) or a visual impairment that would interfere with using a robot or using hearing aids and hearing assistive technologies;\n4. have limited access to electricity at home.","ALL","65 Years","90 Years",{"count":43,"type":44},40,"ESTIMATED","INTERVENTIONAL",[47],"NA","Objectives To assess the feasibility and acceptability of using a home-based, social robot-assisted intervention (SRAI) for older adults with hearing loss (HL), and to examine the preliminary effects of SRAI on improving physical activity, loneliness, communication, and health-related quality of life in this population.\n\nHypothesis to be tested SRAI is feasible for implementation at home and acceptable to participants. Upon completing the 10-week intervention and the 1-month follow-up, the intervention group (IG) will report significantly greater improvements in measured outcomes. These findings will support subsequent investigations in a larger-scale randomized controlled trial (RCT).\n\nDesign and subjects A two-arm, single-blinded, pilot RCT with individual semi-structured interviews. Chinese adults aged 65 years or older, with mild-to-moderate HL with a pure-tone average of 20-50 dB across octave frequencies 0.5 to 4kHz in both ears.\n\nStudy instruments This study will feature a 2 kg, 30 cm tall and 20 cm wide, Cantonese-speaking humanoid social robot named KaKa.\n\nInterventions Each IG participant will receive SRAI at home for 10 weeks. This will include auditory rehabilitation and 60 min\u002Fday, 3 days\u002Fweek of varied multicomponent physical activity following the World Health Organization's evidence-based recommendations. The control group will engage in physical activity at the same intensity level and frequency as the IG without a robot.\n\nMain outcome measures Physical activity levels.\n\nData analysis Descriptive statistics, an independent sample t-test or chi square test, generalized estimating equation and thematic analysis will be used.\n\nExpected results Participants could benefit from incorporating tailored intervention for physical activity with auditory rehabilitation.",[50],"Age-related Hearing Loss",[52,53,54],"age-related hearing loss","physical activity","health-related quality of life","NOT_YET_RECRUITING","2025-03-11",{"date":58,"type":59},"2025-03-14","ACTUAL",{"date":61,"type":44},"2025-05",{"date":63,"type":44},"2027-03",{"name":5,"class":6}]