FHSS
Hong Kong
NCT Number: NCT07308691
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.
This study is active but is not currently recruiting participants.
60 year–90 year
All sexes
Interventional
Not applicable
Hong Kong
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This intervention combines generative AI conversational interface with therapist backend monitoring. It supplements (does not replace) 2x/week outpatient occupational therapy, focusing on conservative distal radius fracture.
standard outpatient occupational therapy rehabilitation for conservatively treated distal radius fractures (2 sessions/week for 12 weeks) plus a conventional paper-based home exercise program. This includes printed instructions for daily wrist range of motion, strengthening, and functional exercises, with weekly paper exercise logs for self-monitoring. No digital tools, reminders, or interactive features are provided.
Time frame: 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.
The Hong Kong Polytechnic University
Other
Acronym: OT FDR CHATBOT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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