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

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

Study Overview

• Status: Recruiting
• Conditions: Physical Activity; Dementia; Caregiver; Psychological Well Being
• Intervention / Treatment: Other: Intervention; Other: Control

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Hong Kong Polytechnic University
    • Contact: Shanshan Wang; Phone Number: +85227664696; Email: shan-shan.wang@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Tweleve weeks of robot-assisted tailored activity programme	Other: Intervention; 12 weeks of robot assisted tailored activity programme
Other: Control; Usual care provided by community centers	Other: Control; Usual care provided by community centers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-intervention and immediately post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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.	Pre-intervention and immediately post-intervention

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Estimated): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Behavior; Personal Satisfaction; Dementia; Psychological Well-Being; Motor Activity; Investigative Techniques; Methods
• Other Study ID Numbers: P0044775

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No