An interventional study of A social robot KaKa-assisted intervention in Age-related Hearing Loss, sponsored by The Hong Kong Polytechnic University. Not yet recruiting. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Supportive care
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.
66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 45 interventional studies indexed under Presbycusis.
Browse Presbycusis studies →The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study will feature a 2 kg, 30 cm tall and 20 cm wide, Cantonese-speaking humanoid social robot named KaKa.
Behavioral: A social robot KaKa-assisted intervention
physical activity at the same intensity level and frequency as the IG without a robot.
Behavioral: A social robot KaKa-assisted intervention
A social robot KaKa-assisted intervention (SRAI) to provide auditory rehabilitation and physical activity program
Physical activity levels (objectively)
A wrist-worn ActiGraph GT3X+, valid step counter will be used to measure daily step-count.2
Time frame: 10 weeks
Physical activity levels (subjectively)
will be measured using the Chinese version of the International Physical Activity Questionnaire.
Time frame: 10 weeks
Loneliness
will be measured using the 6-item De Jong Gierveld Loneliness Scale (Chinese version)
Time frame: 10 weeks
Communication
will be measured using Chinese version of the Hearing Handicap Inventory for the elderly (HHIE)
Time frame: 10 weeks
Health-related quality of life (HRQL)
will be assessed using the Medical Outcomes Study 36-item Short Form Health Survey (SF-36; Chinese version)
Time frame: 10 weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for Sep 2025, 4 months later.
Of 25 interventional studies with no phase under Presbycusis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 58. This study's planned 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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The Hong Kong Polytechnic University →