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NCT Number: NCT06878339

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

A social robot KaKa-assisted intervention

Behavioral

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

Primary outcomes

  1. Physical activity levels (objectively)

    Time frame: 10 weeks

    A wrist-worn ActiGraph GT3X+, valid step counter will be used to measure daily step-count.2

  2. Physical activity levels (subjectively)

    Time frame: 10 weeks

    will be measured using the Chinese version of the International Physical Activity Questionnaire.

Secondary outcomes

  1. Loneliness

    Time frame: 10 weeks

    will be measured using the 6-item De Jong Gierveld Loneliness Scale (Chinese version)

  2. Communication

    Time frame: 10 weeks

    will be measured using Chinese version of the Hearing Handicap Inventory for the elderly (HHIE)

  3. Health-related quality of life (HRQL)

    Time frame: 10 weeks

    will be assessed using the Medical Outcomes Study 36-item Short Form Health Survey (SF-36; Chinese version)

Study contacts

Contact information is provided by the study sponsor or research team.

Ivy Zhao, PhD

CONTACT

[email protected]

+8527664550

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Mar 14, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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