【ChiCTR2500099547】Smart digitalized intervention for fall prevention of older adults in residential care facilities: a feasibility study and pilot randomized controlled trial (RCT)

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基本信息

登记号

ChiCTR2500099547

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2025-03-25

临床申请受理号

靶点

适应症

Fall in older adults

试验通俗题目

Smart digitalized intervention for fall prevention of older adults in residential care facilities: a feasibility study and pilot randomized controlled trial (RCT)

试验专业题目

Smart digitalized intervention for fall prevention of older adults in residential care facilities: a feasibility study and pilot randomized controlled trial (RCT)

申办单位信息

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临床试验信息

试验目的

1. The primary aim of the proposed study is to investigate the effect of a 16-week integrated Otago Exercise Program with an AI-embedded smart wearable system on balance control, functional mobility, physical activity level, exercise self-efficacy, and other health outcomes for older adults at individual level in residential care facilities. 2. The secondary aim is to examine how participants perceive their experience in the program to understand their concerns, challenges, and long-term engagement.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

A computer-generated randomization list for concealed allocation will be conducted by a research staff independent of the trial.

盲法

The research assistant (RA1) will oversee all the assessments and will be blinded to the group allocation.

试验项目经费来源

Health and Medical Research Fund - Research Fellowship Scheme (Reference number: 09230037)

试验范围

目标入组人数

实际入组人数

第一例入组时间

2025-04-19

试验终止时间

2026-10-01

是否属于一致性

入选标准

1. 65 years or older； 2. Living in residential care facilities； 3. cannot finish chair stand test in 14s； 4. have a score lower than 9 in Short Physical Performance Battery.；

排除标准

1. Need an assistive device to ambulate indoors; 2. Have been hospitalized for >6 months in the past one year; 3. Have a history of any neurological disorders or general medical or musculoskeletal problems that limited functional activities, or have undergone orthopedic surgery to the joints of trunk and/or lower limbs, any current injuries, significant foot deformities; 4. Have severe vision or hearing difficulties or cognitive impairment (Mini Mental State Exam score <24) that limited activities of daily living or communication.；

研究者信息

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试验机构

The Hong Kong Polytechnic University

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