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临床试验/NCT04635579
NCT04635579已完成不适用

Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation

University of Washington2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年5月8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
40
试验地点
2
主要终点
Knee Varus

研究概览

简要总结

This is a cross-sectional study on the use of personalized blood flow restriction during rehabilitation exercises and its effects on biomechanics on people who have had an anterior cruciate ligament reconstruction and healthy controls

详细描述

Rehabilitation after surgical reconstruction of the anterior cruciate ligament (ACL) aims to reestablish the function of the knee. However, regaining previous levels of strength is challenging, with long-term muscle weakness frequently reported and thought to play a key role in the increased risk of knee osteoarthritis for individuals with a history of ACL damage. Effectively building muscle strength requires exercises with high resistance loads, however the joint stress and risk of further injury makes these types of activities inappropriate and unsafe for those rehabilitating after ACL reconstruction surgery and other injuries. Personalized blood flow restriction (BFR) training is a technique where the blood flow to the muscles being exercised is controlled by a pressure cuff to a predefined level, and has been shown to increase strength while exercising with significantly lower loads. Early results have been promising, however the effects of BFR on the biomechanics of the exercise as well as the acceptability in the ACL reconstruction population have not been explored. In this application, we propose a cross-sectional study designed to test the acceptability of BFR training for those undergoing rehabilitation from ACL reconstruction surgery and healthy controls during free standing exercises. We will also investigate the biomechanical effects of this rehabilitation technique. This application is part of a larger program of musculoskeletal research in this area being developed by the team. The results from the proposed project will inform the design of a clinical trial of personalized BFR after ACL reconstruction.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • Any other orthopaedic, neurological, or other condition within the last 12 months that would affect ability to carry out the required exercises
  • Any medical conditions that may affect circulation including, but not limited to, deep vein thrombosis, high blood pressure, and cardiac disease

结局指标

主要结局

Knee Varus

时间窗: 6 minutes

Maximum difference in varus motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees

Hip Internal Rotation Moment

时间窗: 6 minutes

Maximum difference in internal rotation moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram

Hip Adduction

时间窗: 6 minutes

Maximum difference in adduction motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees

Hip Internal Rotation

时间窗: 6 minutes

Maximum difference in internal rotation motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees

Hip Flexion

时间窗: 6 minutes

Maximum difference in flexion motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees

Knee Flexion

时间窗: 6 minutes

Maximum difference in flexion motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees

Knee Internal Rotation

时间窗: 6 minutes

Maximum difference in internal rotation of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees

Knee Internal Rotation Moment

时间窗: 6 minutes

Maximum difference in internal rotation moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram

Knee Adduction Moment

时间窗: 6 minutes

Maximum difference in adduction moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram

Hip Extension Moment

时间窗: 6 minutes

Maximum difference in extension moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram.

Knee Extension Moment

时间窗: 6 minutes

Maximum difference in extension moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram

Hip Adduction Moment

时间窗: 6 minutes

Maximum difference in adduction moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram

次要结局

  • Exercise Difficulty Score(6 minutes)
  • Exercise Discomfort Score(6 minutes)

研究者

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

Scott Telfer, EngD

Assistant Professor: School of Medicine

University of Washington

研究点 (2)

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