- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07416877
The Effects of Dual-Task Exercises on Parameters After Total Knee Arthroplasty
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Necati Muhammed Tat, Asst.Prof
- Phone Number: +905075083347
- Email: necatimuhammedtat@yyu.edu.tr
Study Contact Backup
- Name: Anıl Sensever, Physiotherapist
- Phone Number: +905308926718
- Email: anilsensever82@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Having undergone revision or bilateral knee replacement surgery,
- Having experienced postoperative complications,
- Having undergone lower extremity surgery,
- Having a neurological disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Home Exercise Group: Control Group
|
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.
|
|
Experimental: Dual Task Exercises: Physiotherapy Group
Dual Task Exercises
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reaction time
Time Frame: 8 weeks
|
The total time and average time until the light turns off were recorded.
|
8 weeks
|
|
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.
|
8 weeks
|
|
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.
|
8 weeks
|
|
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.
|
8 weeks
|
|
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.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: 8 weeks
|
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.
|
8 weeks
|
|
Dynamic balance
Time Frame: 8 weeks
|
The functional reach test will be used in the dynamic balance assessment.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Necati Muhammed Tat, Asst.Prof., Van Yuzuncu Yil University, Faculty of Health Science
- Principal Investigator: Anıl Şensever
- Study Chair: Mehmet Ata Gökalp, Prof.Dr., Van Yuzuncu Yil University, Faculty of Medicine
- Principal Investigator: Şilan Kaplan
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Van YYUYL1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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