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临床试验/NCT03421938
NCT03421938撤回不适用

Investigation of the Effect of Downhill-uphill Walking Exercises on Functional Level and Muscle Strength in Patients With Knee Arthroplasty.

Dokuz Eylul University2 个研究点 分布在 1 个国家开始时间: 2017年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change of Iowa Level of Assistance Scale

研究概览

简要总结

This study is planned for investigating effect of downhill-uphill walking exercises on functional level and muscle strength in patients with knee arthroplasty. Patients who have had primary knee arthroplasty and has gone 3 months after surgery will be included in this study. The patients will be divided into two groups by randomization. Totally, 22 patients will be included in this study. Every patients will have same standart post-operative rehabilitation programme. In addition,group 1 will have downhill walking exercises with %10 slope; group 2 uphill walking exercises on the treadmill with %10 slope. Assessments will be made before and after treatment.

详细描述

This study is planned for investigating effect of downhill-uphill walking exercises on functional level and muscle strength in patients with knee arthroplasty. Patients who have had primary knee arthroplasty and has gone 3 months after surgery will be included in this study. The patients will be divided into two groups by randomization. Totally, 22 patients will be included in this study. Every patients will have same standart post-operative rehabilitation programme. Assessments will be made before and after treatment. Rehabilitation programme after knee arthroplasty has included muscle strength and endurance, balance and proprioceptive sensation, increasing functional level and providing independence in daily life activities.For this purpose, a standard physiotherapy program will be implemented in accordance with the goals and objectives stated for all patients. In addition,group 1 will have downhill walking exercises with %10 slope; group 2 uphill walking exercises on the treadmill with %10 slope. It takes 30 minutes for one session.

Exercise intensity was measured before treatment; will be determined using the Karvonen formula depending on the heart rate. Walking intensity during exercise; 55% of the maximum heart rate will be determined at the beginning of the treatment and 85% towards the end of the treatment. Walking exercise on the treadmill will be performed in conjunction with a qualified physiotherapist in this area for 4 weeks(3 session in 1 week).

Within the scope of the assessments, patients' pain levels will be determined using the Numeric Pain Scale (NAS). For the knee joint, the normal range of motion will be determined by universal goniometer. For the determination of functional level, Iowa functional activity scale, Iowa ambulatory speed scale and Hospital For Special Surgery (HSS) knee scoring, 10-meter walking speed, Timed Up and Go (TUG) test, SF-12(12-Item Short Form Survey) quality of life scale will be used. Hand dynamometer will be used to evaluate muscle strength.These assessments will be made before and after treatment.

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
Single (Participant)

入排标准

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

入选标准

  • Preoperative diagnosis have to be knee osteoarthritis.
  • Patients with primary knee arthroplasty after 3 months surgery.

排除标准

  • BMI >40 kg/m2
  • Having orthopedic or neurologic disorders which cause walking disorders.
  • Revision total knee arthroplasty

结局指标

主要结局

Change of Iowa Level of Assistance Scale

时间窗: Change from Baseline Patient's Functional Level at 4 weeks

This test assesses the patient's ability to perform four functional activities, namely, supine to sitting on the edge of the bed,sitting on the edge of the bed to standing, walking 4.57 metres. The scoring of these activities is done as independent 6 points, observational aid 5 points, minimum help 4 points, medium help 3 points, maximum help 2 points, fail 1 point and untest 0 points. Higher values represent a better outcome. Speed scoring is done by evaluating the walking speed at a distance of 13.4 meters (44 steps). 20 seconds (sec) and below are recorded as 0, 21-30 sec 1, 31-40 sec 2, 41-50 3, 51-60 sec 4, 61-70 sec 5 and 70 sec. Higher values represent a worse outcome

Change of Hospital For Special Surgery Knee Score

时间窗: Change from Baseline Patient's Functional Level at 4 weeks

Hospital for Special Surgery knee score. A scoring system evaluation of pain, mobility, range of motion and deforming of the knee giving 0-100 points

Change of 10 meter walk speed test

时间窗: Change from Baseline Patient's Functional Level at 4 weeks

Individual walks without assistance 10 meters and the time is measured for the intermediate 6 meters to allow for acceleration and deceleration, start timing when the toes of the leading foot crosses the 2-meter mark, stop timing when the toes of the leading foot crosses the 8-meter mark,assistive devices can be used but should be kept consistent and documented from test to test, if physical assistance is required to walk, this should not be performed can be performed at preferred walking speed or fastest speed possible documentation should include the speed tested (preferred vs. fast) collect three trials and calculate the average of the three trials

Change of Timed Up and Go (TUG)

时间窗: Change from Baseline Patient's Functional Level at 4 weeks

To determine fall risk and measure the progress of balance, sit to stand, and walking.The patient starts in a seated position. The patient stands up upon therapist's command walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. The subject is allowed to use an assistive device.

次要结局

  • SF-12(Change from Baseline SF-12 score Level at 4 weeks)
  • Numeric Pain Scale(Change from Baseline Patient's Pain Level at 4 weeks)
  • Muscle Strength(Change from Baseline Patient's Muscles Strengths at 4 weeks)
  • Range of Motion(Change from Baseline Patient's Range of Motion 4th week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdurrahman Nalbant

Principal Investigator

Dokuz Eylul University

研究点 (2)

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