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临床试验/NCT07416877
NCT07416877尚未招募不适用

The Effects of Dual-Task Exercises on Pain, Balance, Function, and Reaction Time After Total Knee Arthroplasty

Yuzuncu Yil University0 个研究点目标入组 40 人开始时间: 2026年2月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
主要终点
Reaction time

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Home Exercise Group: Control Group

Active Comparator

干预措施: Home Exercises (Other)

Dual Task Exercises: Physiotherapy Group

Experimental

Dual Task Exercises

干预措施: Home Exercises (Other)

Dual Task Exercises: Physiotherapy Group

Experimental

Dual Task Exercises

干预措施: Dual Task Exercises (Other)

结局指标

主要结局

Reaction time

时间窗: 8 weeks

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

WOMAC Osteoarthritis Index

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Dynamic balance(8 weeks)
  • Pain Intensity(8 weeks)

研究者

发起方
Yuzuncu Yil University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Necati Muhammed TAT

Assistant Professor

Yuzuncu Yil University

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