Total Knee ArthroplastyNCT07416877
The Effects of Dual-Task Exercises on Parameters After Total Knee Arthroplasty
A study testing Home Exercises and Dual Task Exercises in people with Total Knee Arthroplasty and Dual Task Exercises, run by Yuzuncu Yil University.
Trial summary
Introduction: Total knee arthroplasty (TKA) is a widely used surgical treatment method worldwide for advanced pain and functional loss resulting from osteoarthritis and other degenerative knee pathologies. The aim of TKA is to reduce pain, restore joint function, and improve quality of life. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Total Knee Arthroplasty, Dual Task Exercises
- What is being tested?
- Home Exercises and Dual Task Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 15 Sep 2026
- 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mini Mental State Test score ≥24; ability to provide signed informed consent and voluntary agreement to participate in the study.
- Underwent primary unilateral total knee replacement surgery.
- Being between 50 and 65 years old
Who cannot join
- Having undergone revision or bilateral knee replacement surgery,
- Having experienced postoperative complications,
- Having undergone lower extremity surgery,
- Having a neurological disease.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effects of Dual-Task Exercises on Pain, Balance, Function, and Reaction Time After Total Knee Arthroplasty
Introduction: Total knee arthroplasty (TKA) is a widely used surgical treatment method worldwide for advanced pain and functional loss resulting from osteoarthritis and other degenerative knee pathologies. The aim of TKA is to reduce pain, restore joint function, and improve quality of life. Although many patients experience a significant reduction in pain after surgery, balance problems, risk of falls, and functional limitations may persist in the postoperative period.In addition, loss of performance may occur in daily tasks requiring motor-cognitive interaction (e.g., talking while walking, changing direction while carrying objects).The dual-task paradigm describes exercises and assessments that require the simultaneous execution of both motor and cognitive tasks; in rehabilitation, it aims to improve daily living functions by targeting the simultaneous functioning of motor and cognitive systems.In the literature, studies on dual-task assessment and training in individuals with knee osteoarthritis and TKA are limited, and the findings are heterogeneous. Studies in elderly and osteoarthritic populations have reported that both single-task and dual-task training improve balance performance, but dual-task training does not always show a clear superiority compared to single-task training. These studies have generally focused on balance and gait parameters; evidence on how other clinically important variables such as pain, reaction time, and fear of movement (kinesiophobia) change with dual-task interventions is insufficient and inconsistent.
Method: The effect size of the WOMAC Osteoarthritis Index assessment parameter in the reference article is 1.02. It was calculated that a minimum of 20 individuals in total, 10 in each group, were required for a study with 80% power, using a type I error of α=0.05 and a type II error of β=0.20.After obtaining informed consent from all participants, their sociodemographic information will be recorded. Subsequently, their cognitive status will be assessed using the Mini Mental State Test (MMSE).Pain will be assessed using the Numerical Pain Rating Scale (NPRS). Functional mobility will be assessed using the Timed Up and Go (TUG). Dynamic balance will be assessed using the Functional Reach Test. Static balance will be assessed using the Berg Balance Scale (BBS). Functionality will be assessed using the WOMAC Osteoarthritis Index. Kinesiophobia will be assessed using the Tampa Kinesiophobia Scale (TKS). Lower extremity reaction time will be assessed using the Fitlight Trainer (FITLIGHT Sports Corp., Ontario, Canada), a wireless system consisting of 8 sensors.Interventions: After participants were randomly divided into two groups, those in the control group would perform a physiotherapy program consisting of strengthening and balance exercises at home, provided by us, and would not participate in any other exercise program during the study period. Exercises would be taught to the control group in person by a physiotherapist at the time of the initial assessment, and follow-up sessions would be video-recorded. The intervention group's program would be a dual-task exercise program, in addition to the exercises provided in the home exercise program. Interventions would last for 8 weeks, 2 days a week, and the program would be updated weekly.
- Conditions
- Total Knee Arthroplasty, Dual Task Exercises
- Being tested
- Home Exercises, Dual Task Exercises
- Keywords
- Total knee arthroplasty, dual task exercises, exercise, reaction time, functionality, kinesiophobia
- Medical subject headings
- Motor Activity, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home ExercisesOther
Home exercises consisting of strengthening and balance exercises at home and will not engage in any other exercise programs during the study period.The interventions will last for 8 weeks, 2 days a week, and the program will be updated each week.
Dual Task ExercisesOther
In addition to the home exercise program, a dual-task exercise program will be implemented.The interventions will last for 8 weeks, 2 days a week, and the program will be updated each week.
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise Group: Control Group | Active comparator | Not described Receives: Other: Home Exercises |
| Dual Task Exercises: Physiotherapy Group | Experimental | Dual Task Exercises Receives: Other: Home Exercises; Other: Dual Task Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time
The total time and average time until the light turns off were recorded.
Measured: 8 weeks
WOMAC Osteoarthritis Index
This is a 24-item self-report scale used to assess functional status after osteoarthritis and TKA (Total Knee Arthroplasty). It has three sub-dimensions: pain (5 items), stiffness (2 items), and physical function (17 items). Each item is scored between 0 and 4. A higher score indicates a worse functional level.
Measured: 8 weeks
Kinesiophobia
The Tampa Kinesiophobia Scale (TKS) will be used for assessment. The TKS is a 17-item scale that measures fear of movement and re-injury. Each item is scored from 1 to 4; the total score ranges from 17 to 68. A higher score indicates a greater fear of movement.
Measured: 8 weeks
Functional Mobility
The TUG test measures the time, in seconds, for an individual to stand up from a chair, walk 3 meters, turn around, and sit back down. It comprehensively evaluates functional mobility, balance, walking speed, and lower extremity strength.
Measured: 8 weeks
Static Balance
The Berg Balance Scale (BDS) will be used for assessment. The BDS is a 14-item scale that evaluates an individual's static and dynamic balance skills. Each item is scored between 0 and 4; the total score ranges from 0 to 56.
Measured: 8 weeks
Secondary outcomes (2)
Pain Intensity
Pain will be assessed using the Numerical Pain Rating Scale (NPRS). Pain intensity is evaluated on a numerical scale of 0-10; 0 = no pain, 10 = unbearable pain.
Measured: 8 weeks
Dynamic balance
The functional reach test will be used in the dynamic balance assessment.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necati Muhammed TAT, Yuzuncu Yil University
- Investigators
- Necati Muhammed Tat, Asst.Prof., Study chair, Van Yuzuncu Yil University, Faculty of Health ScienceAnıl Şensever, Principal investigatorMehmet Ata Gökalp, Prof.Dr., Study chair, Van Yuzuncu Yil University, Faculty of MedicineŞilan Kaplan, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416877
- Sponsor's protocol ID
- Van YYUYL1
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study Protocol and Statistical Analysis Plan
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dual-Task Exercises on Pain, Balance, Function, and Reaction Time After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07416877
- Acronym / sponsor ID
- Van YYUYL1
- Conditions
- Total Knee Arthroplasty, Dual Task Exercises
- Keywords
- Total knee arthroplasty, dual task exercises, exercise, reaction time, functionality, kinesiophobia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 18 Feb 2026 (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.
Introduction: Total knee arthroplasty (TKA) is a widely used surgical treatment method worldwide for advanced pain and functional loss resulting from osteoarthritis and other degenerative knee pathologies. The aim of TKA is to reduce pain, restore joint function, and improve quality of life. Although many patients experience a significant reduction in pain after surgery, balance problems, risk of falls, and functional limitations may persist in the postoperative period.In addition, loss of performance may occur in daily tasks requiring motor-cognitive interaction (e.g., talking while walking, changing direction while carrying objects).The dual-task paradigm describes exercises and assessments that require the simultaneous execution of both motor and cognitive tasks; in rehabilitation, it aims to improve daily living functions by targeting the simultaneous functioning of motor and cognitive systems.In the literature, studies on dual-task assessment and training in individuals with knee osteoarthritis and TKA are limited, and the findings are heterogeneous. Studies in elderly and osteoarthritic populations have reported that both single-task and dual-task training improve balance performance, but dual-task training does not always show a clear superiority compared to single-task training. These studies have generally focused on balance and gait parameters; evidence on how other clinically important variables such as pain, reaction time, and fear of movement (kinesiophobia) change with dual-task interventions is insufficient and inconsistent.
Method: The effect size of the WOMAC Osteoarthritis Index assessment parameter in the reference article is 1.02. It was calculated that a minimum of 20 individuals in total, 10 in each group, were required for a study with 80% power, using a type I error of α=0.05 and a type II error of β=0.20.After obtaining informed consent from all participants, their sociodemographic information will be recorded. Subsequently, their cognitive status will be assessed using the Mini Mental State Test (MMSE).Pain will be assessed using the Numerical Pain Rating Scale (NPRS). Functional mobility will be assessed using the Timed Up and Go (TUG). Dynamic balance will be assessed using the Functional Reach Test. Static balance will be assessed using the Berg Balance Scale (BBS). Functionality will be assessed using the WOMAC Osteoarthritis Index. Kinesiophobia will be assessed using the Tampa Kinesiophobia Scale (TKS). Lower extremity reaction time will be assessed using the Fitlight Trainer (FITLIGHT Sports Corp., Ontario, Canada), a wireless system consisting of 8 sensors.Interventions: After participants were randomly divided into two groups, those in the control group would perform a physiotherapy program consisting of strengthening and balance exercises at home, provided by us, and would not participate in any other exercise program during the study period. Exercises would be taught to the control group in person by a physiotherapist at the time of the initial assessment, and follow-up sessions would be video-recorded. The intervention group's program would be a dual-task exercise program, in addition to the exercises provided in the home exercise program. Interventions would last for 8 weeks, 2 days a week, and the program would be updated weekly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Exercise Group: Control Group | Active comparator | Other: Home Exercises |
| Dual Task Exercises: Physiotherapy Group | Experimental | Other: Home Exercises, Other: Dual Task ExercisesDual Task Exercises |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mini Mental State Test score ≥24; ability to provide signed informed consent and voluntary agreement to participate in the study.
- Underwent primary unilateral total knee replacement surgery.
- Being between 50 and 65 years old
Key exclusion criteria (4 listed)
- Having undergone revision or bilateral knee replacement surgery,
- Having experienced postoperative complications,
- Having undergone lower extremity surgery,
- Having a neurological disease.
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 |
|---|---|---|
| Home ExercisesHome exercises consisting of strengthening and balance exercises at home and will not engage in any other exercise programs during the study period.The interventions will last for 8 weeks, 2 days a week, and the program will be updated each week. | Other | Dual Task Exercises: Physiotherapy Group, Home Exercise Group: Control Group |
| Dual Task ExercisesIn addition to the home exercise program, a dual-task exercise program will be implemented.The interventions will last for 8 weeks, 2 days a week, and the program will be updated each week. | Other | Dual Task Exercises: Physiotherapy Group |
Primary outcome
Reaction time
Time frame: 8 weeks
The total time and average time until the light turns off were recorded.
WOMAC Osteoarthritis Index
Time frame: 8 weeks
This is a 24-item self-report scale used to assess functional status after osteoarthritis and TKA (Total Knee Arthroplasty). It has three sub-dimensions: pain (5 items), stiffness (2 items), and physical function (17 items). Each item is scored between 0 and 4. A higher score indicates a worse functional level.
Kinesiophobia
Time frame: 8 weeks
The Tampa Kinesiophobia Scale (TKS) will be used for assessment. The TKS is a 17-item scale that measures fear of movement and re-injury. Each item is scored from 1 to 4; the total score ranges from 17 to 68. A higher score indicates a greater fear of movement.
Functional Mobility
Time frame: 8 weeks
The TUG test measures the time, in seconds, for an individual to stand up from a chair, walk 3 meters, turn around, and sit back down. It comprehensively evaluates functional mobility, balance, walking speed, and lower extremity strength.
Static Balance
Time frame: 8 weeks
The Berg Balance Scale (BDS) will be used for assessment. The BDS is a 14-item scale that evaluates an individual's static and dynamic balance skills. Each item is scored between 0 and 4; the total score ranges from 0 to 56.
2 secondary outcomes
Pain Intensity
Time frame: 8 weeks
Dynamic balance
Time frame: 8 weeks
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 18 Feb 2026.
- Individual participant dataSharing planned: No. Study Protocol and Statistical Analysis Plan
Related trials for Total Knee Arthroplasty
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Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
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Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
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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.
Necati Muhammed Tat, Asst.Prof. study chair
Van Yuzuncu Yil University, Faculty of Health Science
Anıl Şensever principal investigator
Mehmet Ata Gökalp, Prof.Dr. study chair
Van Yuzuncu Yil University, Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Home Exercises and Dual Task Exercises in people with Total Knee Arthroplasty and Dual Task Exercises, run by Yuzuncu Yil University.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Necati Muhammed Tat, Asst.Prof (+905075083347, necatimuhammedtat@yyu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction time (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2026.