Investigation of Balance, Fall Risk, Gait Performance, and Quality of Life in Postmenopausal Women Undergoing Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Single Leg Standing Test
研究概览
简要总结
Total knee arthroplasty (TKA) is a commonly performed surgical procedure aimed at reducing pain, restoring joint function, and improving quality of life, particularly among older women. Despite improvements in pain and functional outcomes following TKA, findings regarding balance, fall risk, and gait performance remain inconsistent. Impairments in these parameters may adversely affect daily activities, independence, and overall quality of life.
Unlike previous studies that have primarily focused on one or two outcomes, this study will comprehensively evaluate balance, fall risk, gait performance, and quality of life in postmenopausal women who have undergone TKA. The findings are expected to provide a more holistic understanding of long-term functional outcomes following TKA and contribute to the planning of rehabilitation programs. Therefore, the aim of this study is to compare balance, fall risk, gait performance, and quality of life between postmenopausal women who have undergone TKA and healthy postmenopausal women.
详细描述
Total knee arthroplasty (TKA) is one of the most frequently performed surgeries aimed at reducing pain, restoring limb function and alignment, enabling normal joint movement, and increasing the level of independence in daily living activities. TKA is frequently performed in women aged 65-84 years.
In recent years, advancements in surgical techniques and prosthetic technology, along with increased surgeon experience, have broadened the range of indications for this surgery. Following TKA, balance, fall risk, and walking performance in patients can negatively impact their daily living activities and quality of life, preventing the achievement of expected rehabilitation results. While reports indicate a reduction in complaints and an increase in functional level and quality of life after TKA surgery, clear conclusions regarding patients' balance, fall risk, and walking performance have not been reached. This study differs from other studies in the literature by comprehensively evaluating the effects of TKA on critical functional parameters such as balance, fall risk, walking performance, and quality of life in postmenopausal women. While most research focuses on the effect of TDA on only one or two parameters, this study will examine four key components together, providing a more holistic assessment. Evaluating these parameters, which significantly affect the success of TDA surgery, will determine the rehabilitation process and program. Furthermore, the fact that participants scored 24 points or higher on the Mini-Mental Test will increase the reliability of the results by providing a sample capable of cognitive assessment. The aim of this study is to compare the effects of TDA surgery on balance skills, gait performance, fall risk, and quality of life in postmenopausal women who have and have not undergone the procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Volunteering to participate in the study.
- •Being 60 years of age or older.
- •Having a Mini Mental Test score of 24 or higher.
- •Not having undergone previous arthroplasty surgery on the knee where surgery is planned.
- •Having experienced unilateral TDA.
- •Being a postmenopausal woman
排除标准
- •Individuals whose vital signs are unstable after surgery, or who develop any major complications such as deep vein thrombosis, pulmonary embolism, wound infection, or prolonged anesthesia side effects.
- •Presence of any neurological, vestibular, visual, cardiopulmonary, auditory, or cognitive deficits that may affect measurements.
- •Individuals diagnosed with diabetes.
研究组 & 干预措施
control group
not having undergone TKA
干预措施: TKA group (Other)
结局指标
主要结局
Single Leg Standing Test
时间窗: 1 day
Single Leg Standing (SLJ) Test: Balance assessment will be performed using the single leg standing (SLJ) test. In the SLJ test, participants will be asked to stand with their extremities on the side that has not undergone surgery raised. The duration of the test in this position will be recorded. If the participant completes this position for 30 seconds, the test will be recorded as successful. Sarac et al. determined the validity and reliability of the SLJ test in TDA patients as an intraclass correlation coefficient \[ICC\]=0.74 (0.48-0.87).
30-Second Sit-to-Stand Test
时间窗: 1 day
For the test, the individual sits in the middle of a chair without armrests, with a seat height of 43.18 cm, with their back straight, arms crossed over their chest, and feet flat on the floor. Upon the "Start" command, they rise from the chair without pushing off with their arms, stand upright, and then sit down again. Prior to the evaluation, the individual is assessed for two sit-to-stand repetitions to ensure they have learned the procedure. The number of correct standing repetitions within 30 seconds is recorded as the test value.
Timed Up and Walk Test
时间窗: 1 day
The individual is asked to stand up from a chair, walk 3 meters at a safe and normal pace, turn around, walk back, and sit back down in the chair. The time is recorded in seconds. The test will be initiated with the patient's feet flat on the floor and their arms resting on the armrests of the chair. Three repetitions will be performed, and the best result will be recorded.
10-Meter Walking Test
时间窗: 1 day
The 10-meter walking test will be used to assess walking ability. In this test, the individual will be asked to walk at their normal pace in a pre-measured 10-meter area (with or without walking aids). The timer will start when the individual's foot is on the starting line and end when they cross the finish line. Two measurements will be taken, and the best value will be recorded in meters per second (m/s).
Oxford Knee Score
时间窗: 1 day
It is a scale developed in 1998 to investigate pain and functional status in individuals with knee replacement, and its validity and reliability have been proven (47). The validity and reliability of the score in Turkish was proven by the research conducted by Tugay et al. in 2016 (48). The Oxford knee score is a score consisting of 12 questions that include the problems the individual has experienced in their knee in the last 4 weeks. The questions will be answered by individuals choosing the most appropriate situation for themselves from 5 answers related to each question. The answers given will be scored from 0-4 and the results will be totaled. The raw score is a value between 0-48.
次要结局
未报告次要终点
研究者
Nurcan Contarli
Lecturer
Karabuk University