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

NCT ID: NCT07239869

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-08-31

Brief Summary

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

Detailed Description

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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

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Dementia Caregiver Physical Activity Psychological Well Being

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

Tweleve weeks of robot-assisted tailored activity programme

Group Type EXPERIMENTAL

Intervention

Intervention Type OTHER

12 weeks of robot assisted tailored activity programme

Control

Usual care provided by community centers

Group Type OTHER

Control

Intervention Type OTHER

Usual care provided by community centers

Interventions

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Intervention

12 weeks of robot assisted tailored activity programme

Intervention Type OTHER

Control

Usual care provided by community centers

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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;
* have no intention to send the care recipient to nursing homes in the next six months;
* being physically inactive;
* use a smartphone.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Facility Contacts

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Shanshan Wang

Role: primary

Other Identifiers

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P0044775

Identifier Type: -

Identifier Source: org_study_id