Knee Arthroplasty, TotalNCT06162208
Action Observation Therapy Via Telerehabilitation on Total Knee Arthroplasty Surgery
A study testing Standard exercise program based on telerehabilitation in people with Knee Arthroplasty, Total and Telerehabilitation, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare patient-reported and performance-based outcomes of patients followed with a standard exercise program based on telerehabilitation and patients followed with action observation therapy program added to a standard exercise program based on telerehabilitation after total knee… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Arthroplasty, Total, Telerehabilitation
- What is being tested?
- Standard exercise program based on telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 31 Dec 2025
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer
- 40 years and older
- Undergo primary unilateral total knee arthroplasty surgery after the diagnosis of osteoarthritis
- Can understand, speak and write Turkish
- Understand verbal and written information given
- Internet access
- Able to use video conferencing program
Who cannot join
- Revision total knee arthroplasty surgery
- Previous major surgery on the extremity to be operated on
- Additional comorbid diseases such as rheumatoid arthritis, cancer
- Has any engine defect that may affect performance
- With a diagnosed psychiatric disorder
- People with alcohol or drug addiction
Show all 12Show fewer
- Hearing or visual impairment that cannot be corrected with hearing aids or glasses
- Morbidly obese (BMI > 40 kg/m2)
- Who will not be able to participate in a six-week rehabilitation program
- Patients who did not come to follow-up after surgery for any reason,
- Patients who want to leave the study,
- Patients who are unable to continue the study due to an additional condition will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale University
Denizli, 20000
Nihal Büker, Prof., +90 258 296 42 73, nasuk@pau.edu.tr
Nevriye Ünal Süzer, Msc, PT
About this study
Official title: Examining the Effect of Action Observation Therapy Added to the Telerehabilitation-Based Standard Exercise Program on Patient-Reported and Performance-Based Outcomes in Patients Undergoing Total Knee Arthroplasty Surgery
The goal of this clinical trial is to compare patient-reported and performance-based outcomes of patients followed with a standard exercise program based on telerehabilitation and patients followed with action observation therapy program added to a standard exercise program based on telerehabilitation after total knee arthroplasty surgery.
The main questions it aims to answer are:
Read more
- [What is the effect of action observation therapy added to a telerehabilitation-based standard exercise program on patient-reported outcomes after total knee arthroplasty surgery?]
- [What is the effect of action observation therapy added to a telerehabilitation-based standardized exercise program on performance-based outcomes after total knee arthroplasty surgery?]
Participants will be divided into three groups by computer-assisted randomization method: Group 1: home exercise with information leaflet group, Group 2: information leaflet + telerehabilitation-based standard exercise program group, Group 3: information leaflet + telerehabilitation-based standard exercise program + action observation therapy group.
Patients in the second and third groups will be followed up with the telerehabilitation method accompanied by a physiotherapist for 30 minutes 3 days a week for 6 weeks after discharge. The third group will receive a standard exercise program 3 days a week and 15 minutes of action observation therapy via video conferencing.
Read the detailed description
The goal of this clinical trial is to compare patient-reported and performance-based outcomes of patients followed with a standard exercise program based on telerehabilitation and patients followed with action observation therapy program added to a standard exercise program based on telerehabilitation after total knee arthroplasty surgery.
The secondary aim is to investigate the effect of a telerehabilitation-based standard exercise program added to the home program (information leaflet) on patient-reported and performance-based outcomes.
The surgical operations of all patients participating in the study will be performed by the same surgical team and a standard physiotherapy program will be applied to all patients until discharge.
Participants will be divided into three groups by computer-assisted randomization method: Group 1: home exercise with information leaflet group, Group 2: information leaflet + telerehabilitation-based standard exercise program group, Group 3: information leaflet + telerehabilitation-based standard exercise program + action observation therapy group.
Patients in the second and third groups will be followed up with the telerehabilitation method accompanied by a physiotherapist for 30 minutes 3 days a week for 6 weeks after discharge. The third group will receive a standard exercise program 3 days a week and 15 minutes of action observation therapy via video conferencing.
Telerehabilitation sessions will include information about the process and exercise training. Action observation therapy will include showing videos of the exercises in the exercise program. All patients will be evaluated before surgery and at the third, sixth, and twelfth weeks after discharge.
Evaluations
Descriptive Data: Descriptive data of the patients will be recorded using an evaluation form.
Patient Reported Assessments:
- Western Ontario McMaster University Osteoarthritis Index (WOMAC): This index questions clinically significant problems in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and knee.
- Pain intensity: Pain intensity will be assessed with the Visual Analog Scale (VAS).
- Knee range of motion: Active and passive knee range of motion will be measured in the sitting position with a digital goniometer (HALO Medical Devices, Australia)
- Quality of Life Assessment: Knee Injury and Osteoarthritis Outcome Score - Activities of Daily Livings Scale (KOOS-ADLS) and EuroQol Group (EQ-5D) scales will be used for quality of life assessment.KOOS-ADLS is a scale used to detect symptoms and limitations in daily life tasks.The EQ-5D index scale consists of a questionnaire with five dimensions (movement, self-care, usual activities, pain/discomfort and anxiety/depression).
- Physical activity assessment: International Physical Activity Survey (IPAQ-Short Form) and smart phone pedometer application (Samsung Health®) will be used for physical activity assessment. The IPAQ-Short Form consists of 7 questions asking about various degrees of physical activity and sedentary behaviors in the past 1 week.
- Patient Satisfaction Assessments: Patient satisfaction with telerehabilitation sessions will be assessed. Technical quality (such as reliability of technology, quality of audio/video synchronization, quality of image, quality of sound), achievement of treatment goals of the session and overall satisfaction with the session will be questioned.
Performance Based Assessments:
The tests recommended by the research groups of 30 seconds of sit and stand, 40 meters fast walking and stair climbing will be used.
- Lower extremity muscle strength: Lower extremity muscle strength will be assessed by 30 seconds sit and stand test.
- Walking speed: In the 40-meter walk test, the patient is asked to walk a distance of 40 meters as fast as possible and the time in seconds is recorded.
- Locomotor performance: Locomotor performance will be assessed with the stair climbing test. The patient will be asked to ascend and descend 9 steps 16-20 centimeters long stairs as quickly but safely as possible.
- Conditions
- Knee Arthroplasty, Total, Telerehabilitation
- Being tested
- Standard exercise program based on telerehabilitation
- Keywords
- Telerehabilitation, Action Observation Therapy, Total Knee Arthroplasty, Patient-Reported Outcomes, Performance-Based Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard exercise program based on telerehabilitationOther
Also called Action observation therapy added to a standard exercise program based on telerehabilitation
Exercises included in a standard exercise program based on telerehabilitation; Week 0-3 Patellar mobilization Isometric quadriceps femoris exercise Terminal extension exercise Active assisted knee flexion Straight leg lift Active hip abduction Active assisted knee flexion in sitting SAFTE Cold pack application Week 3-6 Straight leg raises with weights Hip abduction in weighted side lying Knee flexion in the prone position Knee extension in weight-bearing sitting Sliding forward in the chair to increase the knee flexion angle Standing weighted hip abduction Standing knee flexion with weight Squat Walking Climbing stairs Action observation therapy will be practiced by watching videos of all exercises with a focus on close-up action.
| Study group | Role | What they receive |
|---|---|---|
| Home exercise group with information leaflet | No intervention | These patients will be asked to do the exercises in the information leaflet themselves at home. |
| İnformation brochure+standard exercise program group based on telerehabilitation | Active comparator | Patients in this group will be followed up with telerehabilitation method accompanied by a physiotherapist for 30 minutes 3 times a week for 6 weeks after discharge. Receives: Other: Standard exercise program based on telerehabilitation |
| İnformation brochure+standard exercise program+action observation therapy group. | Active comparator | Patients in this group will be followed up with telerehabilitation method accompanied by a physiotherapist for 30 minutes 3 times a week for 6 weeks after discharge. In addition, 15 minutes of movement observation therapy will be applied via video conferencing 3 days a week. Receives: Other: Standard exercise program based on telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, stiffness and physical function (WOMAC)
- Western Ontario McMaster University Osteoarthritis Index (WOMAC): This index questions clinically significant problems in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and knee.
Measured: 5 minutes
Pain intensity
Pain intensity will be assessed with the Visual Analog Scale (VAS).
Measured: 2 minutes
Knee range of motion
Active and passive knee range of motion will be measured in the sitting position with a digital goniometer (HALO Medical Devices, Australia).
Measured: 5 minutes
Physical activity assessment
IPAQ-Short Form and smartphone pedometer application (Samsung Health®) will be used for physical activity assessment. The IPAQ-Short Form consists of 7 questions asking about various degrees of physical activity and sedentary behaviors in the past 1 week.
Measured: 5 minutes
Lower extremity muscle strength
Lower extremity muscle strength will be assessed by 30 seconds sit and stand test.
Measured: 30 seconds
Walking speed
In the 40-meter walk test, the patient is asked to walk a distance of 40 meters as fast as possible and the time in seconds is recorded.
Measured: Average 5 minutes
Locomotor performance
Locomotor performance will be assessed with the stair climbing test. The patient will be asked to ascend and descend 9 steps 16-20 centimeters long stairs as quickly but safely as possible.
Measured: Average 5 minutes
Secondary outcomes (2)
Quality of Life Assessment
KOOS-ADLS and EQ-5D scales will be used for quality of life assessment.KOOS-ADLS is a scale used to detect symptoms and limitations in daily life tasks.The EQ-5D index scale consists of a questionnaire with five dimensions (movement, self-care, usual activities, pain/discomfort and anxiety/depression).
Measured: 10 minutes
Patient satisfaction assessment
Patient satisfaction with telerehabilitation sessions will be assessed. Technical quality (such as reliability of technology, quality of audio/video synchronization, quality of image, quality of sound), achievement of treatment goals of the session and overall satisfaction with the session will be questioned.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Dec 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe 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
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihal BÜKER, Pamukkale University
- Investigators
- Sinem Yenil, Msc, PT, Principal investigator, Pamukkale UniversityHarun Reşit Güngör, Prof., Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162208
- Sponsor's protocol ID
- E-60116787-020-39072
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Villafane JH, Isgro M, Borsatti M, Berjano P, Pirali C, Negrini S. Effects of action observation treatment in recovery after total knee replacement: a prospective clinical trial. Clin Rehabil. 2017 Mar;31(3):361-368. doi: 10.1177/0269215516642605. Epub 2016 Jul 10.
PubMed 27068367Windsor EN, Sharma AK, Gkiatas I, Elbuluk AM, Sculco PK, Vigdorchik JM. An Overview of Telehealth in Total Joint Arthroplasty. HSS J. 2021 Feb;17(1):51-58. doi: 10.1177/1556331620972629. Epub 2021 Feb 21.
PubMed 33967642McKeon JF, Alvarez PM, Vajapey AS, Sarac N, Spitzer AI, Vajapey SP. Expanding Role of Technology in Rehabilitation After Lower-Extremity Joint Replacement: A Systematic Review. JBJS Rev. 2021 Sep 13;9(9). doi: 10.2106/JBJS.RVW.21.00016.
PubMed 34516463
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Action Observation Therapy Added to the Telerehabilitation-Based Standard Exercise Program on Patient-Reported and Performance-Based Outcomes in Patients Undergoing Total Knee Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT06162208
- Acronym / sponsor ID
- E-60116787-020-39072
- Conditions
- Knee Arthroplasty, Total, Telerehabilitation
- Keywords
- Telerehabilitation, Action Observation Therapy, Total Knee Arthroplasty, Patient-Reported Outcomes, Performance-Based Outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Dec 2023 (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.
The goal of this clinical trial is to compare patient-reported and performance-based outcomes of patients followed with a standard exercise program based on telerehabilitation and patients followed with action observation therapy program added to a standard exercise program based on telerehabilitation after total knee arthroplasty surgery.
The main questions it aims to answer are:
- [What is the effect of action observation therapy added to a telerehabilitation-based standard exercise program on patient-reported outcomes after total knee arthroplasty surgery?]
- [What is the effect of action observation therapy added to a telerehabilitation-based standardized exercise program on performance-based outcomes after total knee arthroplasty surgery?]
Participants will be divided into three groups by computer-assisted randomization method: Group 1: home exercise with information leaflet group, Group 2: information leaflet + telerehabilitation-based standard exercise program group, Group 3: information leaflet + telerehabilitation-based standard exercise program + action observation therapy group.
Patients in the second and third groups will be followed up with the telerehabilitation method accompanied by a physiotherapist for 30 minutes 3 days a week for 6 weeks after discharge. The third group will receive a standard exercise program 3 days a week and 15 minutes of action observation therapy via video conferencing.
Detailed description
The goal of this clinical trial is to compare patient-reported and performance-based outcomes of patients followed with a standard exercise program based on telerehabilitation and patients followed with action observation therapy program added to a standard exercise program based on telerehabilitation after total knee arthroplasty surgery.
The secondary aim is to investigate the effect of a telerehabilitation-based standard exercise program added to the home program (information leaflet) on patient-reported and performance-based outcomes.
The surgical operations of all patients participating in the study will be performed by the same surgical team and a standard physiotherapy program will be applied to all patients until discharge.
Participants will be divided into three groups by computer-assisted randomization method: Group 1: home exercise with information leaflet group, Group 2: information leaflet + telerehabilitation-based standard exercise program group, Group 3: information leaflet + telerehabilitation-based standard exercise program + action observation therapy group.
Patients in the second and third groups will be followed up with the telerehabilitation method accompanied by a physiotherapist for 30 minutes 3 days a week for 6 weeks after discharge. The third group will receive a standard exercise program 3 days a week and 15 minutes of action observation therapy via video conferencing.
Telerehabilitation sessions will include information about the process and exercise training. Action observation therapy will include showing videos of the exercises in the exercise program. All patients will be evaluated before surgery and at the third, sixth, and twelfth weeks after discharge.
Evaluations
Descriptive Data: Descriptive data of the patients will be recorded using an evaluation form.
Patient Reported Assessments:
- Western Ontario McMaster University Osteoarthritis Index (WOMAC): This index questions clinically significant problems in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and knee.
- Pain intensity: Pain intensity will be assessed with the Visual Analog Scale (VAS).
- Knee range of motion: Active and passive knee range of motion will be measured in the sitting position with a digital goniometer (HALO Medical Devices, Australia)
- Quality of Life Assessment: Knee Injury and Osteoarthritis Outcome Score - Activities of Daily Livings Scale (KOOS-ADLS) and EuroQol Group (EQ-5D) scales will be used for quality of life assessment.KOOS-ADLS is a scale used to detect symptoms and limitations in daily life tasks.The EQ-5D index scale consists of a questionnaire with five dimensions (movement, self-care, usual activities, pain/discomfort and anxiety/depression).
- Physical activity assessment: International Physical Activity Survey (IPAQ-Short Form) and smart phone pedometer application (Samsung Health®) will be used for physical activity assessment. The IPAQ-Short Form consists of 7 questions asking about various degrees of physical activity and sedentary behaviors in the past 1 week.
- Patient Satisfaction Assessments: Patient satisfaction with telerehabilitation sessions will be assessed. Technical quality (such as reliability of technology, quality of audio/video synchronization, quality of image, quality of sound), achievement of treatment goals of the session and overall satisfaction with the session will be questioned.
Performance Based Assessments:
The tests recommended by the research groups of 30 seconds of sit and stand, 40 meters fast walking and stair climbing will be used.
- Lower extremity muscle strength: Lower extremity muscle strength will be assessed by 30 seconds sit and stand test.
- Walking speed: In the 40-meter walk test, the patient is asked to walk a distance of 40 meters as fast as possible and the time in seconds is recorded.
- Locomotor performance: Locomotor performance will be assessed with the stair climbing test. The patient will be asked to ascend and descend 9 steps 16-20 centimeters long stairs as quickly but safely as possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home exercise group with information leaflet | No intervention | –These patients will be asked to do the exercises in the information leaflet themselves at home. |
| İnformation brochure+standard exercise program group based on telerehabilitation | Active comparator | Other: Standard exercise program based on telerehabilitationPatients in this group will be followed up with telerehabilitation method accompanied by a physiotherapist for 30 minutes 3 times a week for 6 weeks after discharge. |
| İnformation brochure+standard exercise program+action observation therapy group. | Active comparator | Other: Standard exercise program based on telerehabilitationPatients in this group will be followed up with telerehabilitation method accompanied by a physiotherapist for 30 minutes 3 times a week for 6 weeks after discharge. In addition, 15 minutes of movement observation therapy will be applied via video conferencing 3 days a week. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteer
- 40 years and older
- Undergo primary unilateral total knee arthroplasty surgery after the diagnosis of osteoarthritis
- Can understand, speak and write Turkish
- Understand verbal and written information given
Key exclusion criteria (12 listed)
- Revision total knee arthroplasty surgery
- Previous major surgery on the extremity to be operated on
- Additional comorbid diseases such as rheumatoid arthritis, cancer
- Has any engine defect that may affect performance
- With a diagnosed psychiatric disorder
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 |
|---|---|---|
| Standard exercise program based on telerehabilitationAlso: Action observation therapy added to a standard exercise program based on telerehabilitationExercises included in a standard exercise program based on telerehabilitation; Week 0-3 Patellar mobilization Isometric quadriceps femoris exercise Terminal extension exercise Active assisted knee flexion Straight leg lift Active hip abduction Active assisted knee flexion in sitting SAFTE Cold pack application Week 3-6 Straight leg raises with weights Hip abduction in weighted side lying Knee flexion in the prone position Knee extension in weight-bearing sitting Sliding forward in the chair to increase the knee flexion angle Standing weighted hip abduction Standing knee flexion with weight Squat Walking Climbing stairs Action observation therapy will be practiced by watching videos of all exercises with a focus on close-up action. | Other | İnformation brochure+standard exercise program group based on telerehabilitation, İnformation brochure+standard exercise program+action observation therapy group. |
Primary outcome
Pain, stiffness and physical function (WOMAC)
Time frame: 5 minutes
• Western Ontario McMaster University Osteoarthritis Index (WOMAC): This index questions clinically significant problems in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and knee.
Pain intensity
Time frame: 2 minutes
Pain intensity will be assessed with the Visual Analog Scale (VAS).
Knee range of motion
Time frame: 5 minutes
Active and passive knee range of motion will be measured in the sitting position with a digital goniometer (HALO Medical Devices, Australia).
Physical activity assessment
Time frame: 5 minutes
IPAQ-Short Form and smartphone pedometer application (Samsung Health®) will be used for physical activity assessment. The IPAQ-Short Form consists of 7 questions asking about various degrees of physical activity and sedentary behaviors in the past 1 week.
Lower extremity muscle strength
Time frame: 30 seconds
Lower extremity muscle strength will be assessed by 30 seconds sit and stand test.
Walking speed
Time frame: Average 5 minutes
In the 40-meter walk test, the patient is asked to walk a distance of 40 meters as fast as possible and the time in seconds is recorded.
Locomotor performance
Time frame: Average 5 minutes
Locomotor performance will be assessed with the stair climbing test. The patient will be asked to ascend and descend 9 steps 16-20 centimeters long stairs as quickly but safely as possible.
2 secondary outcomes
Quality of Life Assessment
Time frame: 10 minutes
Patient satisfaction assessment
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Background: PubMed 27068367Villafane JH, Isgro M, Borsatti M, Berjano P, Pirali C, Negrini S. Effects of action observation treatment in recovery after total knee replacement: a prospective clinical trial. Clin Rehabil. 2017 Mar;31(3):361-368. doi: 10.1177/0269215516642605. Epub 2016 Jul 10.
- Background: PubMed 33967642Windsor EN, Sharma AK, Gkiatas I, Elbuluk AM, Sculco PK, Vigdorchik JM. An Overview of Telehealth in Total Joint Arthroplasty. HSS J. 2021 Feb;17(1):51-58. doi: 10.1177/1556331620972629. Epub 2021 Feb 21.
- Background: PubMed 34516463McKeon JF, Alvarez PM, Vajapey AS, Sarac N, Spitzer AI, Vajapey SP. Expanding Role of Technology in Rehabilitation After Lower-Extremity Joint Replacement: A Systematic Review. JBJS Rev. 2021 Sep 13;9(9). doi: 10.2106/JBJS.RVW.21.00016.
- Individual participant dataSharing planned: No
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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.
Sinem Yenil, Msc, PT principal investigator
Pamukkale University
Harun Reşit Güngör, Prof. principal investigator
Pamukkale 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 Standard exercise program based on telerehabilitation in people with Knee Arthroplasty, Total and Telerehabilitation, run by Pamukkale 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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 8 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nevriye Ünal Süzer, Msc, PT (+90 554 274 42 80, nevriyeunal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain, stiffness and physical function (WOMAC) (time frame: 5 minutes). The study lists 7 primary outcomes in all. 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 NCT06162208, which also lists 3 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 8 Dec 2023.