Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07239869

A Robot-assisted Tailored Activity Programme for People With Dementia and Their Caregivers

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention

Other

12 weeks of robot assisted tailored activity programme

Control

Other

Usual care provided by community centers

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in self-efficacy in physical activity

    Time frame: Pre-intervention and immediately post-intervention

    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.

  2. Changes in quality of life

    Time frame: Pre-intervention and immediately post-intervention

    Dyadic quality of life will be measured with the 12-item Short Form Survey (SF-12). Higher scores indicate better quality of life

  3. Changes in neuropsychiatric symptoms of people with dementia

    Time frame: Pre-intervention and immediately post-intervention

    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

  4. Changes in psychological well-being

    Time frame: Pre-intervention and immediately post-intervention

    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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.