Fracture Distal RadiusOT FDR CHATBOTNCT07308691
Evaluating a Novel Rehabilitation Chatbot: A Pilot Randomized Controlled Trial for Distal Radius Fracture Recovery
A study testing Wrist Health chatbot and Conventional DRF rehabilitation in people with Fracture Distal Radius, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Fracture Distal Radius
- What is being tested?
- Wrist Health chatbot and Conventional DRF rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Dec 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Wrist Health chatbot, Conventional DRF rehabilitation
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional DRF rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Primary time point: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start2 Dec 2025
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fracture Distal RadiusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Hong Kong
- Responsible party
- Sponsor
- Investigators
- Lun Yan Ngan, Master, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308691
- Sponsor's protocol ID
- CIRB-2025-568-5
- Acronym
- OT FDR CHATBOT
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: small sample sizes, re-identification concerns, and resource limitations for data preparation.
Publications
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.
PubMed 22942849
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Novel Rehabilitation Chatbot: A Pilot Randomized Controlled Trial for Distal Radius Fracture Recovery
- ClinicalTrials.gov ID
- NCT07308691
- Acronym / sponsor ID
- OT FDR CHATBOT / CIRB-2025-568-5
- Conditions
- Fracture Distal Radius
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Hong Kong
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chatbot with conventional rehabilitation | Experimental | Device: Wrist Health chatbotParticipants 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. |
| Conventional Rehabilitation Only | Active comparator | Other: Conventional DRF rehabilitationParticipants 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. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Illiterate or unable to read Chinese.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wrist Health chatbotThis 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. | Device | Chatbot with conventional rehabilitation |
| Conventional DRF rehabilitationstandard 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 Rehabilitation Only |
Primary outcome
PRWE change from baseline to 12 weeks (functional recovery)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Background: PubMed 22942849Amorosa 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.
- Individual participant dataSharing planned: No. small sample sizes, re-identification concerns, and resource limitations for data preparation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lun Yan Ngan, Master principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wrist Health chatbot and Conventional DRF rehabilitation in people with Fracture Distal Radius, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRWE change from baseline to 12 weeks (functional recovery) (time frame: Primary time point: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07308691, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.