DementiaPhase 1NCT07239869
A Robot-assisted Tailored Activity Programme for People With Dementia and Their Caregivers
A Phase 1 study testing Intervention in people with Dementia and Caregiver, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
To assess the feasibility and preliminary efficacy of the tailored activity programme on improving the physical inactivity of the caregiving dyads. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Caregiver, Physical Activity
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2025to 31 Aug 2026
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- primary informal caregivers who reside with the of the person with dementia;
- have provided care for more than six months;
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- have no intention to send the care recipient to nursing homes in the next six months;
- being physically inactive;
- use a smartphone.
Who cannot join
- 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.
- caregivers with unstable physical or mental conditions;
- cannot communicate logically;
- not suitable for doing physical activity as recommended by a primary care physician.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Shanshan Wang, +85227664696, shan-shan.wang@polyu.edu.hk
About this study
Official title: An AI Robot-assisted Tailored Activity Programme for Improving the Physical Inactivity of People With Dementia and Their Informal Caregivers
To assess the feasibility and preliminary efficacy of the tailored activity programme on improving the physical inactivity of the caregiving dyads.
Read the 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.
- Conditions
- Dementia, Caregiver, Physical Activity, Psychological Well Being
- Being tested
- Intervention, Control
- Medical subject headings
- Dementia, Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
12 weeks of robot assisted tailored activity programme
ControlOther
Usual care provided by community centers
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Tweleve weeks of robot-assisted tailored activity programme Receives: Other: Intervention |
| Control | Other | Usual care provided by community centers Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in physical activity
Physical 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.
Measured: Pre-intervention and immediately post-intervention
Secondary outcomes (4)
Changes in self-efficacy in physical activity
Self-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.
Measured: Pre-intervention and immediately post-intervention
Changes in quality of life
Dyadic quality of life will be measured with the 12-item Short Form Survey (SF-12). Higher scores indicate better quality of life
Measured: Pre-intervention and immediately post-intervention
Changes in neuropsychiatric symptoms of people with dementia
People 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
Measured: Pre-intervention and immediately post-intervention
Changes in psychological well-being
Dyads' 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.
Measured: Pre-intervention and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Sep 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 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
- NCT07239869
- Sponsor's protocol ID
- P0044775
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An AI Robot-assisted Tailored Activity Programme for Improving the Physical Inactivity of People With Dementia and Their Informal Caregivers
- ClinicalTrials.gov ID
- NCT07239869
- Acronym / sponsor ID
- P0044775
- Conditions
- Dementia, Caregiver, Physical Activity, Psychological Well Being
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 20 Nov 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: InterventionTweleve weeks of robot-assisted tailored activity programme |
| Control | Other | Other: ControlUsual care provided by community centers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- primary informal caregivers who reside with the of the person with dementia;
Key exclusion criteria (7 listed)
- 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.
- caregivers with unstable physical or mental conditions;
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 |
|---|---|---|
| Intervention12 weeks of robot assisted tailored activity programme | Other | Intervention |
| ControlUsual care provided by community centers | Other | Control |
Primary outcome
Changes in physical activity
Time frame: Pre-intervention and immediately post-intervention
Physical 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.
4 secondary outcomes
Changes in self-efficacy in physical activity
Time frame: Pre-intervention and immediately post-intervention
Changes in quality of life
Time frame: Pre-intervention and immediately post-intervention
Changes in neuropsychiatric symptoms of people with dementia
Time frame: Pre-intervention and immediately post-intervention
Changes in psychological well-being
Time frame: Pre-intervention and immediately post-intervention
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 18 Dec 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intervention in people with Dementia and Caregiver, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in physical activity (time frame: Pre-intervention and immediately post-intervention). 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 18 Dec 2025.