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.

Study Overview

• Status: Not yet recruiting
• Conditions: Age-related Hearing Loss
• Intervention / Treatment: Behavioral: A social robot KaKa-assisted intervention

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ivy Zhao, PhD; Phone Number: +8527664550; Email: yan-ivy.zhao@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: a home-based, social robot-assisted intervention (SRAI) for older adults with hearing loss; 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; A social robot KaKa-assisted intervention (SRAI) to provide auditory rehabilitation and physical activity program
Active Comparator: control group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity levels (objectively)	A wrist-worn ActiGraph GT3X+, valid step counter will be used to measure daily step-count.2	10 weeks
Physical activity levels (subjectively)	will be measured using the Chinese version of the International Physical Activity Questionnaire.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loneliness	will be measured using the 6-item De Jong Gierveld Loneliness Scale (Chinese version)	10 weeks
Communication	will be measured using Chinese version of the Hearing Handicap Inventory for the elderly (HHIE)	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)	10 weeks

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: physical activity; health-related quality of life; age-related hearing loss
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss, Sensorineural; Hearing Loss; Deafness; Presbycusis
• Other Study ID Numbers: 09230027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No