NCT07416877

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Feb 2026Sep 2026

First Submitted

Initial submission to the registry

February 11, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 11, 2026

Last Update Submit

February 11, 2026

Conditions

Keywords

Total knee arthroplastydual task exercisesexercisereaction timefunctionalitykinesiophobia

Outcome Measures

Primary Outcomes (5)

  • Reaction time

    The total time and average time until the light turns off were recorded.

    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.

    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.

    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.

    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.

    8 weeks

Secondary Outcomes (2)

  • Pain Intensity

    8 weeks

  • Dynamic balance

    8 weeks

Study Arms (2)

Home Exercise Group: Control Group

ACTIVE COMPARATOR
Other: Home Exercises

Dual Task Exercises: Physiotherapy Group

EXPERIMENTAL

Dual Task Exercises

Other: Home ExercisesOther: Dual Task Exercises

Interventions

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 Exercises: Physiotherapy GroupHome Exercise Group: Control Group

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.

Dual Task Exercises: Physiotherapy Group

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Having undergone revision or bilateral knee replacement surgery,
  • Having experienced postoperative complications,
  • Having undergone lower extremity surgery,
  • Having a neurological disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor ActivityKinesiophobia

Condition Hierarchy (Ancestors)

BehaviorPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Necati Muhammed Tat, Asst.Prof.

    Van Yuzuncu Yil University, Faculty of Health Science

    STUDY CHAIR
  • Anıl Şensever

    PRINCIPAL INVESTIGATOR
  • Mehmet Ata Gökalp, Prof.Dr.

    Van Yuzuncu Yil University, Faculty of Medicine

    STUDY CHAIR
  • Şilan Kaplan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Necati Muhammed Tat, Asst.Prof

CONTACT

Anıl Sensever, Physiotherapist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 18, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Study Protocol and Statistical Analysis Plan