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临床试验/CTRI/2024/07/069756
CTRI/2024/07/069756尚未招募不适用

Correlation Of Fear Of Fall With Balance And Pain In Patients With Bilateral Total Knee Arthroplasty Post 6 Months.

Dr. Jyotsna Thosar1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1. Fall Efficacy Scale International

研究概览

简要总结

After six months of total knee replacement surgery, the patient is expected to be performing all daily activities, such as driving, shopping, and cooking, and to be nearly normal in society. This calls for multitasking, ambulating in crowded locations, and having adequate lower limb function. Functional recovery is important to be able to perform daily activities as well as participate in a community. Fear of Fall can affect this ability. Therefore, this study aims to find Correlation of Fear of Fall with Balance and Pain in patients with bilateral total knee arthroplasty post 6 months. 30 participants will be selected based on the inclusion and exclusion criteria. Informed consent will be taken and if they agree to participate in this study, they will be included in the study. A one-time assessment of 15-20 minutes will be performed. They will be asked about their demographic data (name, age, etc.). Their Fear of Fall will be assessed using Fall Efficacy Scale International. It has 16 Questions where each question has 4 possible responses: 1-not at all concerned; 2-somewhat concerned; 3-fairly concerned; 4-very concerned. They will be asked to mark an option that is appropriate for them. Next, the Timed Up and Go (TUG) test will be taken. In this, the participant will sit in the chair with their back against the chair back. On the command “go”, he/she will rise form the chair, walk 3 meters at a comfortable and safe pace, turn, walk back to the chair and sit down. Timing will begin at the instruction “go’ and stop when they are seated. They will have one practice trial that is not included in the score. Then Pain will be assessed using Visual Analogue Scale, in this a 10 cm line will be drawn and patient will be asked to mark a point between 2 endpoints (No pain at all and Worst Possible pain) and The distance between ‘no pain at all’ and the mark then defines the patient’s pain. Once all the data has been collected, it will be analyzed using the statistical tests. Depending upon the normality of the data, Pearson’s or Spearman’s coefficient will be calculated.

研究设计

研究类型
Observational

入排标准

年龄范围
50.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients who had undergone bilateral TKA for degenerative arthritis between 6 months to 1 year.
  • Patients in the age group of 50.

排除标准

  • Patients with Revision Total Knee Arthroplasty.
  • Patients with any known postoperative complications like joint infection, loosening of prosthesis, etc.
  • Patients with any known history of previous knee surgery.
  • Any known traumatic, inflammatory, neurological, vestibular and, vascular conditions affecting either lower limb.
  • Patients with any known psychological conditions.

结局指标

主要结局

1. Fall Efficacy Scale International

时间窗: Once 6 Months Post Bilateral Total Knee Arthroplasty

2. Timed Up and Go Test.

时间窗: Once 6 Months Post Bilateral Total Knee Arthroplasty

3. Visual Analogue Scale.

时间窗: Once 6 Months Post Bilateral Total Knee Arthroplasty

次要结局

未报告次要终点

研究者

发起方
Dr. Jyotsna Thosar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Jyotsna Thosar

P.T School and Centre, Seth GS Medical College and KEM Hospital

研究点 (1)

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