Evaluating a Novel Rehabilitation Chatbot: A Pilot Randomized Controlled Trial for Distal Radius Fracture Recovery
NCT ID: NCT07308691
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
44 participants
INTERVENTIONAL
2025-12-02
2027-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chatbot with conventional rehabilitation
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.
Wrist Health chatbot
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 Rehabilitation Only
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.
Conventional DRF rehabilitation
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.
Interventions
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Wrist Health chatbot
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 rehabilitation
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 Criteria
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Inclusion Criteria
* 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
* 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)
60 Years
90 Years
ALL
No
Sponsors
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Princess Margaret Hospital, Hong Kong
OTHER_GOV
The Hong Kong Polytechnic University
OTHER
Responsible Party
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Principal Investigators
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Lun Yan Ngan, Master
Role: PRINCIPAL_INVESTIGATOR
The Hong Kong Polytechnic University
Locations
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FHSS
Hong Kong, , Hong Kong
Countries
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References
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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.
Other Identifiers
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CIRB-2025-568-5
Identifier Type: -
Identifier Source: org_study_id