{"type":"trials","record":{"id":28379,"source_id":"clinicaltrials-gov","external_id":"NCT06878339","title":"Increasing Physical Activity with a Social Robot-assisted Exercise Intervention in Older Adults with Hearing Loss: a Feasibility and Pilot Randomized Controlled Trial","brief_summary":"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. Hypothesis 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). Design 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. Study instruments This study will feature a 2 kg, 30 cm tall and 20 cm wide, Cantonese-speaking humanoid social robot named KaKa. Interventions Each IG participant will receive SRAI at home for 10 weeks. This will include auditory rehabilitation and 60 min/day, 3 days/week 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. Main outcome measures Physical activity levels. Data analysis Descriptive statistics, an independent sample t-test or chi square test, generalized estimating equation and thematic analysis will be used. Expected results Participants could benefit from incorporating tailored intervention for physical activity with auditory rehabilitation.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"The Hong Kong Polytechnic University","enrollment":40,"countries":[],"start_date":"2025-05-01","completion_date":"2027-03-01","last_update_date":"2025-03-14","source_url":"https://clinicaltrials.gov/study/NCT06878339","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T00:17:13.50034+00:00","last_seen_at":"2026-09-25T06:25:04.647+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"65 Years to 90 Years","comparator":"control group","organization":"The Hong Kong Polytechnic University","interventions":["A social robot KaKa-assisted intervention"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Physical activity levels (objectively) — 10 weeks","Physical activity levels (subjectively) — 10 weeks","Loneliness — 10 weeks","Communication — 10 weeks","Health-related quality of life (HRQL) — 10 weeks"],"design_description":"RANDOMIZED · PARALLEL · SUPPORTIVE CARE · DOUBLE","source_has_results":false},"controlled_terms":["Age-related Hearing Loss","A social robot KaKa-assisted intervention"],"relevance_confidence":70,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Source terminology contains: age-related hearing loss.","quality_checked_at":"2026-09-25T06:25:07.732232+00:00","duplicate_cluster_key":"id:nct06878339","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-05-01 to 2027-03-01","comparator":"control group","confidence":"structured-source","population":"ALL · 65 Years to 90 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:25:04.661Z","intervention":["A social robot KaKa-assisted intervention"],"participants":40,"study_design":"RANDOMIZED · PARALLEL · SUPPORTIVE CARE · DOUBLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Physical activity levels (objectively) — 10 weeks","Physical activity levels (subjectively) — 10 weeks","Loneliness — 10 weeks","Communication — 10 weeks","Health-related quality of life (HRQL) — 10 weeks"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"hearing-aging","is_published":true,"match_reasons":["Source terminology contains: age-related hearing loss.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["controlled terminology","title context","study type"],"relevance_score":70,"intelligence_topics":{"name":"Hearing ageing","slug":"hearing-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/28379","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}