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

N/AActive Not RecruitingNCT07308691

The Hong Kong Polytechnic University44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

Wrist Health chatbotDEVICE

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.

Conventional DRF rehabilitationOTHER

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.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 90 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: Primary time point: 12 weeks