Evaluating a Novel Rehabilitation Chatbot: A Pilot Randomized Controlled Trial for Distal Radius Fracture Recovery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- PRWE change from baseline to 12 weeks (functional recovery)
研究概览
简要总结
This study is a single-center pilot randomized controlled trial evaluating a rehabilitation chatbot, "Wrist Health," for elderly patients (60-90 years) recovering from conservatively treated distal radius fractures in Hong Kong. The trial compares conventional hospital-based rehabilitation plus a conventional home program with the same conventional rehabilitation supplemented by the chatbot, which delivers home exercises, education, reminders, and real-time usage tracking. Participants are randomized 1:1, followed for 12 weeks, and assessed at baseline, week 6, and week 12 using functional measures (range of motion, grip and pinch strength, PRWE), satisfaction, quality of life (EQ-5D-5L), adherence, feasibility metrics, and Technology Acceptance Model-based usability and acceptance outcomes.
Data will be analyzed primarily on an intention-to-treat basis using appropriate parametric or non-parametric tests for between-group comparisons and repeated-measures methods to examine change over time, with qualitative feedback analyzed thematically. The study has obtained/will obtain ethics approval from relevant institutional review boards, uses informed consent procedures, and applies robust data protection measures (password-protected systems, anonymization, locked physical storage, and secure destruction after the retention period). The findings are expected to provide preliminary evidence on clinical usability, feasibility, and effectiveness of the chatbot and to inform the design of a larger, definitive RCT and potential integration of digital rehabilitation tools into routine practice for elderly distal radius fracture patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60-90 years and literate (able to read Chinese).
- •Diagnosis of distal radius fracture (confirmed radiologically).
- •Completed conservative treatment (post injury approximately 6 weeks) and cleared for active rehabilitation.
- •Ability to provide informed consent and comply with study procedures.
- •Access to a compatible smartphone or tablet for chatbot use.
排除标准
- •Illiterate or unable to read Chinese.
- •Cognitive impairment or inability to follow Cantonese instructions.
- •Complications such as complex regional pain syndrome or open fractures with significant soft tissue injury.
- •Bilateral wrist fractures or previous fracture of the unaffected wrist.
- •Concurrent participation in another clinical trial.
- •Significant comorbidities limiting participation in rehabilitation (e.g., severe neurological or psychiatric illness)
结局指标
主要结局
PRWE change from baseline to 12 weeks (functional recovery)
时间窗: Primary time point: 12 weeks
The PRWE is a 15-item validated patient-reported questionnaire assessing wrist pain (5 items) and function/disability in daily activities (10 items), scored 0-100 (higher scores indicate worse pain/function). Participants complete it at baseline (post-fracture stabilization), 6 weeks, and 12 weeks post-rehabilitation start. This captures clinically meaningful recovery in elderly distal radius fracture patients.
次要结局
未报告次要终点