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临床试验/NCT03325062
NCT03325062已完成不适用

Movement Pattern Biofeedback Training After Total Knee Arthroplasty

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2018年1月19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
138
试验地点
2
主要终点
Change in Peak Knee Extension Moment (PKEM) during walking at fixed speed

研究概览

简要总结

This research study explores the effects of movement pattern training using real-time biofeedback insoles after total knee arthroplasty. The purpose of this research study is to determine if the addition of a novel movement pattern training program (MOVE) to contemporary progressive rehabilitation leads to improved movement quality and physical function compared to contemporary progressive rehabilitation (CONTROL) alone.

详细描述

Currently in the United States, more than 700,000 total knee arthroplasty (TKA) surgeries are performed annually, with projections of 3.5 million performed annually by 2030. The increasing incidence of TKA comes with an immediate need for establishing optimal rehabilitation guidelines to remediate common post-TKA physical impairments and improve functional outcomes. Over the past decade, a primary focus of the investigators' TKA rehabilitation research has been on progressive strengthening, which improves muscle strength and physical function, and is now the contemporary approach to TKA rehabilitation. However, a major issue remaining for patients rehabilitating from unilateral TKA is the persistence of atypical movement patterns. These atypical movement patterns, observed during walking and other functional tasks, are characterized by disuse of the surgical limb, resulting in smaller knee extension moments on the surgical limb compared to the non-surgical limb. As a result, atypical movement patterns following unilateral TKA are associated with persistent quadriceps weakness and poor physical function.

The investigators will conduct a randomized controlled trial of 150 participants undergoing unilateral TKA to determine if the addition of a novel movement pattern training program (MOVE) to contemporary, progressive rehabilitation improves movement pattern quality more than contemporary progressive rehabilitation alone (CONTROL). The secondary goal is to determine if movement pattern training improves long-term physical function. Testing will occur pre-operatively and after TKA at 10 weeks (end of intervention), 6 months (primary endpoint), and 24 months.

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
Double (Participant, Outcomes Assessor)

盲法说明

Participants are only informed that they will participate in one of two post-operative rehabilitation programs (without specific details). Outcome assessors are also blinded to group assignment.

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 50-85 years old
  • primary, unilateral knee arthroplasty for end-stage osteoarthritis

排除标准

  • Moderate to severe contralateral knee OA (>4/10 on verbal pain rating (VPR) or KL grade >3)
  • Current smoker
  • Comorbid conditions that substantially limit physical function or would interfere with the participant's ability to successfully complete rehabilitation (e.g. neurologic, vascular, cardiac problems, or ongoing medical treatments)
  • Discharge to location other than home after surgery
  • Unstable orthopedic conditions that limit function
  • Uncontrolled diabetes (hemoglobin A1c level >8.0)
  • Body mass index >40 kg/m2
  • Surgical complication necessitating an altered course of rehabilitation
  • Previous contralateral TKA
  • Unable to safely walk 30m without an assistive device
  • Exclusion criteria for MRI
  • Ferromagnetic metal implants or pacemakers
  • Other contraindications to MRI

结局指标

主要结局

Change in Peak Knee Extension Moment (PKEM) during walking at fixed speed

时间窗: Baseline, 10 weeks, 6 months, and 2 years after surgery

Peak Knee Extension Moment (PKEM) during walking at a fixed speed of 1.0 m/s

次要结局

  • Change in 30-Second Sit-to-Stand Test (30-STS)(Baseline, 10 weeks, 6 months, and 2 years after surgery)
  • Change in Stair Climbing Test (SCT)(Baseline, 10 weeks, 6 months, and 2 years after surgery)
  • Change in Accelerometer-based Physical Activity(Baseline, 10 weeks, 6 months, and 2 years after surgery)
  • Adherence to the intervention(10 weeks after surgery)
  • Change in Six-minute Walk (6MW) Test(Baseline, 10 weeks, 6 months, and 2 years after surgery)
  • Change in Quadriceps Strength(Baseline, 10 weeks, 6 months, and 2 years after surgery)
  • Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Baseline, 10 weeks, 6 months, and 2 years after surgery)
  • Change in Veterans RAND 12 item health survey (VR-12)(Baseline, 10 weeks, 6 months, and 2 years after surgery)
  • Change in knee range of motion (ROM)(Baseline, 10 weeks, 6 months, and 2 years after surgery)
  • Change in PKEM during activities(Baseline, 10 weeks, 6 months, and 2 years after surgery)
  • Change in Timed Up and Go (TUG)(Baseline, 10 weeks, 6 months, and 2 years after surgery)
  • Satisfaction with rehabilitation program(10 weeks after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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