Robot-assisted tailored activity programme for people with dementia and their caregivers
An AI Robot-assisted Tailored Activity Programme for Improving the Physical Inactivity of People With Dementia and Their Informal Caregivers
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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07239869 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hong Kong
- The Hong Kong Polytechnic University — Hong Kong, Hong Kong (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.