Clinical Trial

Evaluating a Novel Rehabilitation Chatbot: A Pilot Randomized Controlled Trial for Distal Radius Fracture Recovery

Study acronym: OT FDR CHATBOT
Active, Not Recruiting
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Summary
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.
Trial Details
NCT Number NCT07308691
Lead Sponsor The Hong Kong Polytechnic University
Collaborators: Princess Margaret Hospital, Hong Kong
Conditions Fracture Distal Radius
Enrollment 44 participants
Start Date 2025-12-02
Primary Completion 2026-11 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2025-12-30