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Increasing Physical Activity with a Social Robot-assisted Exercise Intervention in Older Adults with Hearing Loss: a Feasibility and Pilot Randomized Controlled Trial

Increasing Physical Activity with a Social Robot-assisted Exercise Intervention in Older Adults with Hearing Loss: a Feasibility and Pilot Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06878339
Enrollment
40
Registered
2025-03-14
Start date
2025-05-31
Completion date
2027-03-31
Last updated
2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Hearing Loss

Keywords

age-related hearing loss, physical activity, health-related quality of life

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.

Interventions

BEHAVIORALA social robot KaKa-assisted intervention

A social robot KaKa-assisted intervention (SRAI) to provide auditory rehabilitation and physical activity program

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

1. ethnic Chinese aged ≥65 years old living at home; 2. 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; 3. no cognitive impairment \[score of ≦2 on the 5-item Abbreviated Memory Inventory for the Chinese (AMIC)\]; and 4. 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.

Exclusion criteria

1. those with a diagnosis of a major neurocognitive disorder; 2. a history of symptomatic stroke or other disease of the central nervous system; 3. 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; 4. have limited access to electricity at home.

Design outcomes

Primary

MeasureTime frameDescription
Physical activity levels (objectively)10 weeksA wrist-worn ActiGraph GT3X+, valid step counter will be used to measure daily step-count.2
Physical activity levels (subjectively)10 weekswill be measured using the Chinese version of the International Physical Activity Questionnaire.

Secondary

MeasureTime frameDescription
Loneliness10 weekswill be measured using the 6-item De Jong Gierveld Loneliness Scale (Chinese version)
Communication10 weekswill be measured using Chinese version of the Hearing Handicap Inventory for the elderly (HHIE)
Health-related quality of life (HRQL)10 weekswill be assessed using the Medical Outcomes Study 36-item Short Form Health Survey (SF-36; Chinese version)

Contacts

Primary ContactIvy Zhao, PhD
yan-ivy.zhao@polyu.edu.hk+8527664550

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026