Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 and up

Robot-assisted tailored activity programme for people with dementia and their caregivers

Official title: An AI Robot-assisted Tailored Activity Programme for Improving the Physical Inactivity of People With Dementia and Their Informal Caregivers

Run by The Hong Kong Polytechnic University · NCT07239869 · Data updated 2026-11-12

This trial will try a 12-week robot-assisted, personalized activity programme to increase physical activity for people with mild-to-moderate dementia and their family caregivers.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorThe Hong Kong Polytechnic University
Academic / other
Locations1 site (Hong Kong)
StatusRecruiting
StartedSeptember 1, 2025
Main results expectedAugust 31, 2026
Study endsAugust 31, 2026
Registry record updatedDecember 18, 2025
Trial IDNCT07239869 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal participants are community-dwelling dyads where the person has mild-to-moderate dementia (MMSE > 10), can walk independently, is physically inactive, and lives with a primary informal caregiver who has provided care for at least six months and is also physically inactive.

Probably not a fit

Patients with severe dementia or MMSE ≤ 10, high fall risk, medical contraindications to exercise, frequent recent hospitalizations, those already regularly active, or those planning nursing-home placement are unlikely to benefit from this programme.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This two-arm pilot randomized controlled trial will enroll 60 person-caregiver dyads to test a 12-week robot-assisted tailored activity programme versus usual community care. The intervention delivers personalized physical activities supported by a robot to promote activity among both the person with dementia and their primary caregiver. Primary outcomes include feasibility measures and changes in physical activity levels, with secondary outcomes of self-efficacy for exercise, dyadic quality of life, neuropsychiatric symptoms, and psychological wellbeing. All outcomes are measured at baseline and immediately after the intervention to determine preliminary efficacy and acceptability.

Why it matters

Potential benefit: If successful, the programme could increase daily physical activity and improve mood and quality of life for both people with dementia and their caregivers while offering a scalable support tool.

How similar studies have gone: Tailored activity programmes for dementia have shown benefits for engagement and caregiver outcomes, but robot-assisted delivery is relatively novel and has not yet been validated in larger trials.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria for people with dementia:

* mild to moderate stage dementia at a standardized mini-mental state examination score (MMSE) higher than 10;
* be able to walk independently;
* being physically inactive (categorized as "low/inactive" by the International Physical Activity Questionnaire);
* free from other medical/functional conditions that would limit physical activity.

Exclusion Criteria for people with dementia:

* high risk of falling (Berg Balance Scale \<45);
* not be suitable for doing physical activity as recommended by the primary care physician;
* currently involved in another interventional study involving physical exercise;
* had acute hospitalization \>3 times in the past year.

Inclusion Criteria for caregivers:

* primary informal caregivers who reside with the of the person with dementia;
* have provided care for more than six months;
* have no intention to send the care recipient to nursing homes in the next six months;
* being physically inactive;
* use a smartphone.

Exclusion Criteria for caregivers:

* caregivers with unstable physical or mental conditions;
* cannot communicate logically;
* not suitable for doing physical activity as recommended by a primary care physician.

Where it's running

  • The Hong Kong Polytechnic University
    Hong Kong, Hong Kong
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.