Knee OsteoarthritisNCT05363137
Effectiveness of Using a Chatbot to Promote Adherence to Home Physiotherapy
A study testing Chatbot Assistant in people with Knee Osteoarthritis, run by University of Valencia at 1 site in Spain.
Trial summary
A Chatbot oriented to virtually assist patients in a physiotherapy treatment has been designed and developed to interact with patients with musculoskeletal disorders in need for domiciliary rehabilitation. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Chatbot Assistant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals on the waiting list for total knee replacement surgery
- Undergoing primary total knee replacement surgery
- Who have a personal smartphone
- Who have an instant messaging application installed
- Familiar with the use of such application (more than 3 accesses per week),
Who cannot join
- Evident cognitive state that prevents to understand care provider instructions
- Vestibular or central nervous system affection (e.g. stroke)
- Cannot read or write
- Do not understand Spanish language
- Not able to consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Herramienta De Procesamiento De Lenguaje Natural En Dispositivo Móvil Inteligente Para Fomentar La Adherencia a La Rehabilitación Domiciliaria
A Chatbot oriented to virtually assist patients in a physiotherapy treatment has been designed and developed to interact with patients with musculoskeletal disorders in need for domiciliary rehabilitation. The tool has been designed to promote adherence to rehabilitation, what in turn may have an impact on clinical outcome. A randomized clinical trial involving patients undergoing total knee replacement has bee designed to determine the applicability of the proposal. The participants will be assigned into exerimental group (intervention with the software tool) or control group (standard care).
- Conditions
- Knee Osteoarthritis
- Being tested
- Chatbot Assistant, Standard care
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chatbot AssistantOther
The physiotherpy treatment will be supervised via chatbot
Standard careOther
The physiotherpy treatment will be standard care
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Other: Chatbot Assistant |
| Control | Active comparator | Not described Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Compliance with intervention measured as the percentage of sessions carried out with respect to the total planned
Measured: Change from baseline to 3 months after surgery date
Secondary outcomes (2)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Self-administered questionnaire consisting of 24 items divided into pain, stiffness and physical function will register self-reported status. The score is given from 0 to 100
Measured: Change from baseline to 3 months and one year after surgery date
Knee Pain
Measured with a visual analogue scale of pain, being 0 no pain and 10 the worst possible pain
Measured: Change from baseline to 3 months and one year after surgery date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Sep 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Principal investigator, Jose María Blasco Igual, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363137
- Sponsor's protocol ID
- NLP-PTAdherence
- Status last verified
- Sep 2022
- First submitted
- 2 May 2022
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perez-Maletzki J, Roig-Casasus S, Diaz-Diaz B, Martinez-Garrido I, Hernandez-Guillen D, Blasco JM. A chatbot tool on a smart mobile device to promote adherence to home rehabilitation after total knee replacement: A randomized controlled trial. Physiotherapy. 2026 Sep;132:101872. doi: 10.1016/j.physio.2025.101872. Epub 2025 Dec 18.
PubMed 41934738Blasco JM, Diaz-Diaz B, Igual-Camacho C, Perez-Maletzki J, Hernandez-Guilen D, Roig-Casasus S. Effectiveness of using a chatbot to promote adherence to home physiotherapy after total knee replacement, rationale and design of a randomized clinical trial. BMC Musculoskelet Disord. 2023 Jun 15;24(1):491. doi: 10.1186/s12891-023-06607-3.
PubMed 37322506
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Herramienta De Procesamiento De Lenguaje Natural En Dispositivo Móvil Inteligente Para Fomentar La Adherencia a La Rehabilitación Domiciliaria
- ClinicalTrials.gov ID
- NCT05363137
- Acronym / sponsor ID
- NLP-PTAdherence
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 5 May 2022 (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.
A Chatbot oriented to virtually assist patients in a physiotherapy treatment has been designed and developed to interact with patients with musculoskeletal disorders in need for domiciliary rehabilitation. The tool has been designed to promote adherence to rehabilitation, what in turn may have an impact on clinical outcome. A randomized clinical trial involving patients undergoing total knee replacement has bee designed to determine the applicability of the proposal. The participants will be assigned into exerimental group (intervention with the software tool) or control group (standard care).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Chatbot Assistant |
| Control | Active comparator | Other: Standard care |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals on the waiting list for total knee replacement surgery
- Undergoing primary total knee replacement surgery
- Who have a personal smartphone
- Who have an instant messaging application installed
- Familiar with the use of such application (more than 3 accesses per week),
Key exclusion criteria (5 listed)
- Evident cognitive state that prevents to understand care provider instructions
- Vestibular or central nervous system affection (e.g. stroke)
- Cannot read or write
- Do not understand Spanish language
- Not able to consent to participate
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 |
|---|---|---|
| Chatbot AssistantThe physiotherpy treatment will be supervised via chatbot | Other | Experimental |
| Standard careThe physiotherpy treatment will be standard care | Other | Control |
Primary outcome
Adherence
Time frame: Change from baseline to 3 months after surgery date
Compliance with intervention measured as the percentage of sessions carried out with respect to the total planned
2 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Change from baseline to 3 months and one year after surgery date
Knee Pain
Time frame: Change from baseline to 3 months and one year after surgery date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Derived from this study: PubMed 41934738Perez-Maletzki J, Roig-Casasus S, Diaz-Diaz B, Martinez-Garrido I, Hernandez-Guillen D, Blasco JM. A chatbot tool on a smart mobile device to promote adherence to home rehabilitation after total knee replacement: A randomized controlled trial. Physiotherapy. 2026 Sep;132:101872. doi: 10.1016/j.physio.2025.101872. Epub 2025 Dec 18.
- Derived from this study: PubMed 37322506Blasco JM, Diaz-Diaz B, Igual-Camacho C, Perez-Maletzki J, Hernandez-Guilen D, Roig-Casasus S. Effectiveness of using a chatbot to promote adherence to home physiotherapy after total knee replacement, rationale and design of a randomized clinical trial. BMC Musculoskelet Disord. 2023 Jun 15;24(1):491. doi: 10.1186/s12891-023-06607-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot Assistant in people with Knee Osteoarthritis, run by University of Valencia at 1 site in Spain.
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 5 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: finished, as of the sponsor's last update on 4 Mar 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence (time frame: Change from baseline to 3 months after surgery date). 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 NCT05363137, which also lists 2 linked publications.
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 4 Mar 2025.