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临床试验/NCT03302832
NCT03302832已完成不适用

Effectiveness of Reduced Frequency Physical Therapy Supplemented With In-home Exercise Equipment Compared to Standard Care Physical Therapy in Total Knee Arthroplasty

Campbell University, Incorporated2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

研究概览

简要总结

Rehabilitation after Total Knee Arthroplasty surgery involves physical therapy services to address limitations in range of motion, strength, and participation in normal daily activities. This investigation will compare the outcomes from standard physical therapy intervention in comparison to reduced frequency physical therapy sessions supplemented with in-home exercise equipment.

详细描述

Total knee arthroplasty (TKA) is a common surgical procedure for individuals experiencing pain and reduced physical abilities related to knee pain, most commonly osteoarthritis. Common physical impairments associated with post-operative TKA rehabilitation include: reduced knee range of motion (ROM), reduced strength, reduced participation in activities of daily living, and pain. TKA surgery is routinely paired with physical therapy (PT) interventions post-operatively in order to facilitate recovery for patients electing to undergo this intervention. The Total Range Exerciser (T-REX) is a medical device aimed at reducing the need for post-operative physical therapy services while promoting outcomes.

A successful outcome after total knee arthroplasty requires symptom relief and restoration of physical function. Measurement of pain and function can be achieved through patient-reported outcomes measures and objective functional testing. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a patient-reported outcomes measure intended to capture the individual patient's perception of progress throughout the rehabilitative process. Objective measurements of physical function are necessary to quantify the magnitude of physical impairment associated with the patient's perceived status. Physical function can be measured through standardized assessment of knee ROM, strength, and ambulation. The purpose of this study is to evaluate the effectiveness of standard physical therapy compared to reduced frequency physical therapy supplemented with the (T-REX) after in total knee arthroplasty in subjective and objective measurements of physical function.

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
— 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individual is to undergo TKA by a licensed physician at Participating hospital group
  • Participating primary health insurance provider
  • Patient is < 64.5 years of age
  • Willingness to participate in study protocol

排除标准

  • Previous or current history of cancer
  • High risk for cardiovascular disease as determined by the American College of Sports Medicine
  • Individuals with documented mental, psychiatric, or emotional disabilities
  • Inability to read and write in English

结局指标

主要结局

Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

时间窗: Pre-surgery to 3 months post-surgery

The KOOS measurement is a patient-reported questionnaire that contains 42 questions covering 5 categories (pain, symptoms, activities of daily living, sports and recreation, and quality of life

次要结局

  • Self-reported home exercise compliance/adherence(1 month post-surgery, 2 months post-surgery, 3 months post-surgery)
  • Change in Knee Passive Range of Motion (PROM)(Pre-surgery to 3 months post-surgery)
  • Change in 30 second Chair Stand Test (30s-CST)(Pre-surgery to 3 months post-surgery)
  • Change in Knee Active Range of Motion (AROM)(Pre-surgery to 3 months post-surgery)
  • Change in Timed Up-and-Go Test (TUG)(Pre-surgery to 3 months post-surgery)
  • Change in 6-minute Walk Test (6MWT)(Pre-surgery to 3 months post-surgery)

研究者

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

Bradley Myers

Assistant Professor

Campbell University, Incorporated

研究点 (2)

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