Knee Arthroplasty, TotalNCT06758297
Effect of Artificial Intelligence-Assisted Motivational Talk on Patients' Fear of Movement and Mobility Level After Knee Replacement
A study testing AI-Powered Motivational Speech in people with Knee Arthroplasty, Total, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Patients may have fears about moving after TKA surgery. This fear has been described in the literature. Fear of re-injury has also been called kinesiophobia, which is the primary psychosocial structure in the fear-avoidance model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- AI-Powered Motivational Speech
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2024to 30 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have had knee replacement surgery,
- Be over 18 years of age,
- Agree to participate in the study,
- Be able to understand and speak Turkish,
- Be able to read and write
Who cannot join
- Cancellation or postponement of patient's surgery
- Patients in pain,
- Those whose walking is not recommended by the physician,
- Those with mental disabilities or psychological disorders,
- Patients who are alcohol or drug addicts,
- Those with hearing or visual impairments,
- Patients who do not want to use the headphones that will be used in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Samsun Gazi State Hospital
Samsun, Samsun, 55000
Hatice Merve Alptekin research assistant, +902623034733, merve.alptekin@kocaeli.edu.tr
About this study
Official title: Effect of Artificial Intelligence-Assisted Motivational Talk on Patients' Fear of Movement and Mobility Level After Knee Replacement: a Randomized Controlled Trial
Patients may have fears about moving after TKA surgery. This fear has been described in the literature. Fear of re-injury has also been called kinesiophobia, which is the primary psychosocial structure in the fear-avoidance model. Injury or surgery can create feelings of uncertainty and fear of how much the injury will affect future function. This situation causes the individual to have negative attitudes towards activity. For this reason, kinesiophobia is a psychological element that can affect patient outcomes and recovery after knee trauma or knee surgery. Kinesiophobia is considered a normal reaction in the early postoperative period. However, it can affect patients' early mobility after TKA. It is important to improve functional outcomes in the early period, especially in knee surgeries. Patients may delay mobilization because they feel a fear of falling after surgery, and as this delay increases, their mobility is affected worse. The only solution to this situation, which can enter a vicious circle, is to determine patients' fear of falling and apply interventions accordingly. There are studies in the literature evaluating the fear of movement after total knee arthroplasty and its effect on patients' mobility levels. However, no study has been found investigating the effect of a motivational speech prepared with the help of artificial intelligence on patients. The World Health Organization (WHO) has published a four-year global strategy report on digital health within the scope of the vision of health everywhere and for everyone. According to this report, digital health is defined as "the adoption of digital technologies to improve and develop health". The use of artificial intelligence technology is increasing day by day in the changing and developing world. It is known that nurses constitute 45% of all health professionals in the field of health and that insufficient staff number continues to be a priority problem. It is expected that insufficient staff will be supported and efficiency will increase with the contribution of artificial intelligence, which is the copy of human intelligence with advanced technology. With this research, we aim to both support staff and improve patient outcomes by using artificial intelligence technologies. The aim of this study is to evaluate the effect of an artificial intelligence-supported motivational speech on patients' fear of movement and mobility level after knee replacement.
- Conditions
- Knee Arthroplasty, Total
- Being tested
- AI-Powered Motivational Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Powered Motivational SpeechOther
It is known that patients with knee prosthesis have difficulty in the first standing process due to fears of falling, not being able to walk again, and recurrence of their disease. For this purpose, a speech text that will motivate patients was prepared with the support of "ChatGPT". Expert opinions were obtained from 2 orthopedic specialists and 2 specialist psychiatric nurses for this speech text. Later, the speech text was converted into an audio video with the "ElevenLabs" application. Thus, it was planned to make it easier for patients to listen to it again. Patients will listen to this motivational speech in their own patient rooms and using their own headphones.
| Study group | Role | What they receive |
|---|---|---|
| AI-Powered Motivational Speech Group | Experimental | 1. Patients will be assessed for fear of falling using the "Descriptive Characteristics Form" and the "TAMPA Kinesiophobia Scale".
2. The audio recording prepared with artificial intelligence support will be listened to 3 times.
4. . Patients will be assessed for fear of falling again using the "TAMPA Kinesiophobia Scale".
5. While the patients are standing up, the researcher will measure their mobility levels using the "Patient Mobility and Observer Mobility Scale". Receives: Other: AI-Powered Motivational Speech |
| Control Group | No intervention | 1. Patients will be assessed for fear of falling using the "Descriptive Characteristics Form" and the "TAMPA Kinesiophobia Scale". 2. After 15 minutes, patients will be assessed for fear again using the "TAMPA Kinesiophobia Scale". 3. While the patients are being stood up, the researcher will measure their mobility levels using the "Patient Mobility and Observer Mobility Scale". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiophobia
The patients' fear of falling will be evaluated with the TAMPA Kinesiophobia Scale. The scale is a 17-question scale developed to determine the level of injury/re-injury and fear-avoidance processes related to activities. The scale is scored with a four-point Likert scoring type of "1=Strongly Disagree", "2=Disagree", "3=Agree", "4=Strongly Agree". The minimum score value obtained from the scale is 17, while the maximum score value is 68. Vlaeyen et al. accepted a score above 37 from the scale as a high level of kinesiophobia.
Measured: 20 minutes before the patient starts walking, 5 minutes before the patient starts walking
Secondary outcomes (1)
Mobility Level
The patient's mobility will be assessed with the Patient Mobility and Observer Mobility Scales. The scale is a 5-point Likert-type scale with a 5-point score ranging from "It was very easy" to "It was very difficult". In the Mobility Scale, the dependency/independence status/degree during the performance of four activities after surgery is numbered between 1 and 5. A score of 1 indicates that the patient performed the relevant activity independently without verbal warning or physical assistance, and a score of 5 indicates that the patient could not perform the relevant activity despite verbal warning or physical assistance. The total score is calculated by adding the scores for turning, sitting, standing and walking. A total score of 4-20 is obtained from the scale. An increase in the score indicates that the patient's movement skills are inadequate, and a decrease in the score indicates that their movement skills after the surgical intervention are good/sufficient.
Measured: Simultaneously when the patient first stands up (approximately the 2nd postoperative day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start30 Dec 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (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 Knee Arthroplasty, TotalStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Merve Alptekin, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758297
- Sponsor's protocol ID
- 2025/01
- Status last verified
- Mar 2025
- First submitted
- 26 Dec 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alptekin HM, Ulubay S. The effect of an artificial intelligence-assisted motivational procedure on kinesiophobia and mobility after total knee arthroplasty: a randomized controlled trial. BMC Musculoskelet Disord. 2026 Apr 20;27(1):465. doi: 10.1186/s12891-026-09849-z.
PubMed 42010557
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Artificial Intelligence-Assisted Motivational Talk on Patients' Fear of Movement and Mobility Level After Knee Replacement: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06758297
- Acronym / sponsor ID
- 2025/01
- Conditions
- Knee Arthroplasty, Total
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 3 Jan 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.
Patients may have fears about moving after TKA surgery. This fear has been described in the literature. Fear of re-injury has also been called kinesiophobia, which is the primary psychosocial structure in the fear-avoidance model. Injury or surgery can create feelings of uncertainty and fear of how much the injury will affect future function. This situation causes the individual to have negative attitudes towards activity. For this reason, kinesiophobia is a psychological element that can affect patient outcomes and recovery after knee trauma or knee surgery. Kinesiophobia is considered a normal reaction in the early postoperative period. However, it can affect patients' early mobility after TKA. It is important to improve functional outcomes in the early period, especially in knee surgeries. Patients may delay mobilization because they feel a fear of falling after surgery, and as this delay increases, their mobility is affected worse. The only solution to this situation, which can enter a vicious circle, is to determine patients' fear of falling and apply interventions accordingly. There are studies in the literature evaluating the fear of movement after total knee arthroplasty and its effect on patients' mobility levels. However, no study has been found investigating the effect of a motivational speech prepared with the help of artificial intelligence on patients. The World Health Organization (WHO) has published a four-year global strategy report on digital health within the scope of the vision of health everywhere and for everyone. According to this report, digital health is defined as "the adoption of digital technologies to improve and develop health". The use of artificial intelligence technology is increasing day by day in the changing and developing world. It is known that nurses constitute 45% of all health professionals in the field of health and that insufficient staff number continues to be a priority problem. It is expected that insufficient staff will be supported and efficiency will increase with the contribution of artificial intelligence, which is the copy of human intelligence with advanced technology. With this research, we aim to both support staff and improve patient outcomes by using artificial intelligence technologies. The aim of this study is to evaluate the effect of an artificial intelligence-supported motivational speech on patients' fear of movement and mobility level after knee replacement.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Powered Motivational Speech Group | Experimental | Other: AI-Powered Motivational Speech1. Patients will be assessed for fear of falling using the "Descriptive Characteristics Form" and the "TAMPA Kinesiophobia Scale". 2. The audio recording prepared with artificial intelligence support will be listened to 3 times. 4. . Patients will be assessed for fear of falling again using the "TAMPA Kinesiophobia Scale". 5. While the patients are standing up, the researcher will measure their mobility levels using the "Patient Mobility and Observer Mobility Scale". |
| Control Group | No intervention | –1. Patients will be assessed for fear of falling using the "Descriptive Characteristics Form" and the "TAMPA Kinesiophobia Scale". 2. After 15 minutes, patients will be assessed for fear again using the "TAMPA Kinesiophobia Scale". 3. While the patients are being stood up, the researcher will measure their mobility levels using the "Patient Mobility and Observer Mobility Scale". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient must have had knee replacement surgery,
- Be over 18 years of age,
- Agree to participate in the study,
- Be able to understand and speak Turkish,
- Be able to read and write
Key exclusion criteria (7 listed)
- Cancellation or postponement of patient's surgery
- Patients in pain,
- Those whose walking is not recommended by the physician,
- Those with mental disabilities or psychological disorders,
- Patients who are alcohol or drug addicts,
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 |
|---|---|---|
| AI-Powered Motivational SpeechIt is known that patients with knee prosthesis have difficulty in the first standing process due to fears of falling, not being able to walk again, and recurrence of their disease. For this purpose, a speech text that will motivate patients was prepared with the support of "ChatGPT". Expert opinions were obtained from 2 orthopedic specialists and 2 specialist psychiatric nurses for this speech text. Later, the speech text was converted into an audio video with the "ElevenLabs" application. Thus, it was planned to make it easier for patients to listen to it again. Patients will listen to this motivational speech in their own patient rooms and using their own headphones. | Other | AI-Powered Motivational Speech Group |
Primary outcome
Kinesiophobia
Time frame: 20 minutes before the patient starts walking, 5 minutes before the patient starts walking
The patients' fear of falling will be evaluated with the TAMPA Kinesiophobia Scale. The scale is a 17-question scale developed to determine the level of injury/re-injury and fear-avoidance processes related to activities. The scale is scored with a four-point Likert scoring type of "1=Strongly Disagree", "2=Disagree", "3=Agree", "4=Strongly Agree". The minimum score value obtained from the scale is 17, while the maximum score value is 68. Vlaeyen et al. accepted a score above 37 from the scale as a high level of kinesiophobia.
1 secondary outcome
Mobility Level
Time frame: Simultaneously when the patient first stands up (approximately the 2nd postoperative day)
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 25 Mar 2025.
- Derived from this study: PubMed 42010557Alptekin HM, Ulubay S. The effect of an artificial intelligence-assisted motivational procedure on kinesiophobia and mobility after total knee arthroplasty: a randomized controlled trial. BMC Musculoskelet Disord. 2026 Apr 20;27(1):465. doi: 10.1186/s12891-026-09849-z.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Powered Motivational Speech in people with Knee Arthroplasty, Total, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 7 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: looking for participants now, as of the sponsor's last update on 25 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 Turkey (Türkiye). 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?
Contact Hatice Merve Alptekin research assistant (+90262303004733, merve.alptekin@kocaeli.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinesiophobia (time frame: 20 minutes before the patient starts walking, 5 minutes before the patient starts walking). 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 NCT06758297, 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 25 Mar 2025.