Age-related Hearing LossNCT06878339
Increasing Physical Activity with a Social Robot-assisted Exercise Intervention in Older Adults with Hearing Loss: a Feasibility and Pilot Randomized Controlled Trial
A study testing A social robot KaKa-assisted intervention in people with Age-related Hearing Loss, run by The Hong Kong Polytechnic University.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Age-related Hearing Loss
- What is being tested?
- A social robot KaKa-assisted intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read more
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.
- Conditions
- Age-related Hearing Loss
- Being tested
- A social robot KaKa-assisted intervention
- Keywords
- age-related hearing loss, physical activity, health-related quality of life
- Medical subject headings
- Presbycusis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A social robot KaKa-assisted interventionBehavioural
A social robot KaKa-assisted intervention (SRAI) to provide auditory rehabilitation and physical activity program
| Study group | Role | What they receive |
|---|---|---|
| a home-based, social robot-assisted intervention (SRAI) for older adults with hearing loss | Experimental | This study will feature a 2 kg, 30 cm tall and 20 cm wide, Cantonese-speaking humanoid social robot named KaKa. Receives: Behavioral: A social robot KaKa-assisted intervention |
| control group | Active comparator | physical activity at the same intensity level and frequency as the IG without a robot. Receives: Behavioral: A social robot KaKa-assisted intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity levels (objectively)
A wrist-worn ActiGraph GT3X+, valid step counter will be used to measure daily step-count.2
Measured: 10 weeks
Physical activity levels (subjectively)
will be measured using the Chinese version of the International Physical Activity Questionnaire.
Measured: 10 weeks
Secondary outcomes (3)
Loneliness
will be measured using the 6-item De Jong Gierveld Loneliness Scale (Chinese version)
Measured: 10 weeks
Communication
will be measured using Chinese version of the Hearing Handicap Inventory for the elderly (HHIE)
Measured: 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)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study startMay 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878339
- Sponsor's protocol ID
- 09230027
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Physical Activity with a Social Robot-assisted Exercise Intervention in Older Adults with Hearing Loss: a Feasibility and Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06878339
- Acronym / sponsor ID
- 09230027
- Conditions
- Age-related Hearing Loss
- Keywords
- age-related hearing loss, physical activity, health-related quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a home-based, social robot-assisted intervention (SRAI) for older adults with hearing loss | Experimental | Behavioral: A social robot KaKa-assisted interventionThis study will feature a 2 kg, 30 cm tall and 20 cm wide, Cantonese-speaking humanoid social robot named KaKa. |
| control group | Active comparator | Behavioral: A social robot KaKa-assisted interventionphysical activity at the same intensity level and frequency as the IG without a robot. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A social robot KaKa-assisted interventionA social robot KaKa-assisted intervention (SRAI) to provide auditory rehabilitation and physical activity program | Behavioural | a home-based, social robot-assisted intervention (SRAI) for older adults with hearing loss, control group |
Primary outcome
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
Physical activity levels (subjectively)
Time frame: 10 weeks
will be measured using the Chinese version of the International Physical Activity Questionnaire.
3 secondary outcomes
Loneliness
Time frame: 10 weeks
Communication
Time frame: 10 weeks
Health-related quality of life (HRQL)
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing A social robot KaKa-assisted intervention in people with Age-related Hearing Loss, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivy Zhao, PhD (+8527664550, yan-ivy.zhao@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity levels (objectively) (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.