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

NCT07308691 | Active Not Recruiting

• 1 other identifier: CIRB-2025-568-5
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fracture Distal Radius

Outcome Measures

Primary Outcomes (1)

• PRWE change from baseline to 12 weeks (functional recovery)

  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.

  Primary time point: 12 weeks

Study Arms (2)

Chatbot with conventional rehabilitation

EXPERIMENTAL

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.

Device: Wrist Health chatbot

Conventional Rehabilitation Only

ACTIVE COMPARATOR

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.

Other: Conventional DRF rehabilitation

Interventions

Wrist Health chatbot DEVICE

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.

Chatbot with conventional rehabilitation

Conventional DRF rehabilitation OTHER

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.

Conventional Rehabilitation Only

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Princess Margaret Hospital, Hong Kong: collaborator

Study Sites (1)

FHSS

Hong Kong, Hong Kong

Location

Related Publications (1)

• Amorosa LF, Vitale MA, Brown S, Kaufmann RA. A functional outcomes survey of elderly patients who sustained distal radius fractures. Hand (N Y). 2011 Sep;6(3):260-7. doi: 10.1007/s11552-011-9327-7. Epub 2011 Mar 8.

  PMID: 22942849 BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Lun Yan Ngan, Master

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 30, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)