Evaluating a Novel Rehabilitation Chatbot: A Pilot Randomized Controlled Trial for Distal Radius Fracture Recovery (OT FDR CHATBOT)

The Hong Kong Polytechnic University

Status: Active, not recruiting

Conditions: Fracture Distal Radius

Treatments: Other: Conventional DRF rehabilitation; Device: Wrist Health chatbot

Study type: Interventional

Funder types: Other

Identifiers

NCT07308691

CIRB-2025-568-5

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Chatbot with conventional rehabilitation

Experimental group

Description:

Participants receive standard outpatient occupational therapy rehabilitation for conservatively treated distal radius fractures (2 sessions/week for 12 weeks, focusing on range of motion, strengthening, and functional tasks) plus the "Wrist Health" mHealth chatbot for home-based rehabilitation. The chatbot delivers personalized daily home exercises, educational content on fracture recovery, adherence reminders, real-time progress tracking, and Q\&A support.

Treatment:

Device: Wrist Health chatbot

Conventional Rehabilitation Only

Active Comparator group

Description:

Participants receive 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.

Treatment:

Other: Conventional DRF rehabilitation