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A 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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07239869
Enrollment
60
Registered
2025-11-20
Start date
2025-09-01
Completion date
2026-08-31
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiver, Dementia, Physical Activity, Psychological Well Being

Brief summary

To assess the feasibility and preliminary efficacy of the tailored activity programme on improving the physical inactivity of the caregiving dyads.

Detailed description

This is a two-arm pilot randomized controlled trial evaluating the feasiblity and preliminary efficacy of the robot-assisted tailored activity programme on improving the physical inactivity of people with dementia and their caregivers. Sixty dyads will be rectuited. Participants in the intervention group will receive a 12-week tailored activity programme, while those in the control group will receive usal community care services. Outcomes including feasibility of the tailored acitivity programme, physical activity levels, self-efficacy in physical activity, dyadic quality of life, neuropsychiatric somptoms, and psychological wellbeing will be measured at baseline and immediately post intervention.

Interventions

OTHERIntervention

12 weeks of robot assisted tailored activity programme

OTHERControl

Usual care provided by community centers

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in physical activityPre-intervention and immediately post-interventionPhysical activity will be measured with the Chinese version of the International Physical Activity Questionnaire short version (IPAQ-C, short). The IPAQ-C is a 9-item instrument with good reliability and validity. Objective mesures will include number of steps, movement distance, sedentary minutes, inactive minutes collected with an activity tracker.

Secondary

MeasureTime frameDescription
Changes in self-efficacy in physical activityPre-intervention and immediately post-interventionSelf-efficacy in physical activity will be measured with a Likert 6-point scale covering three different types of self-efficacy. This instrument demonstrated satisfactory internal consistency. Higher scores indicate higher self-efficacy in physical activity.
Changes in quality of lifePre-intervention and immediately post-interventionDyadic quality of life will be measured with the 12-item Short Form Survey (SF-12). Higher scores indicate better quality of life
Changes in neuropsychiatric symptoms of people with dementiaPre-intervention and immediately post-interventionPeople with dementia's neuropsychiatric symptoms will be measured with the Neuropsychiatric Inventory (NPI). NPI evaluates 12 common neuropsychiatric disturbances in dementia. The Chinese version was reliable. Higher scores indicate worse symptoms
Changes in psychological well-beingPre-intervention and immediately post-interventionDyads' psychological well-being will be measured with the Depression Anxiety Stress Scale-21 (DASS-21). DASS-21 includes 3 subscales (stress, anxiety, and depression), and has demonstrated good reliability among the Chinese population. Higher scores indicate poorer psychological wellbeing and more psychological distress.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026