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临床试验/NCT03209531
NCT03209531已完成不适用

Operant Conditioning of Motor Evoked Responses to Improve Quadriceps Function in Individuals With Anterior Cruciate Ligament Reconstruction

University of Michigan2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2017年9月21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
11
试验地点
2
主要终点
Changes in Quadriceps muscle strength

研究概览

简要总结

The purpose of this study is to examine if thigh muscle weakness and the lack of muscle activation that accompanies ACL injury can be improved through a form of mental coaching and encouragement, known as operant conditioning.

详细描述

Thigh muscle weakness is a common result after anterior cruciate ligament (ACL) injury and reconstruction surgery. Therefore, reducing thigh muscle weakness after ACL injury and reconstructive surgery is important as the quadriceps muscles act as shock absorbers that protect the knee joint. If significant weakness is present in the quadriceps, the knee is exposed to increased forces and often results in degeneration of the structures in the joint leading to osteoarthritis. Thus, it is important to investigate activation and strength rehabilitation methods for the quadriceps muscles. This research study is being done to learn if thigh muscle weakness and the lack of muscle activation that accompanies ACL injury can be improved by conditioning brain responses (elicited by non-invasive transcranial magnetic stimulation) using a form of training called as operant conditioning.

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
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • aged 18-45 years
  • suffered an acute, complete ACL rupture
  • have undergone ACL reconstructive surgery
  • willingness to participate in testing and follow-up as outlined in the protocol

排除标准

  • have suffered a previous ACL injury;
  • have undergone previous major surgery to either knee;
  • have a history of recent significant knee injury (other than ACL) or lower-extremity fracture;
  • have a history of uncontrolled diabetes or hypertension;
  • be pregnant or plan to become pregnant;
  • have metal implants in the head;
  • have electronic devices in their ear or heart (e.g., cochlear implants or cardiac pacemakers);
  • have unexplained recurrent headaches;
  • have a recent history of seizures;
  • be taking drugs that reduce seizure threshold;
  • have a history of repeated fainting spells;

结局指标

主要结局

Changes in Quadriceps muscle strength

时间窗: Approximately 8 weeks after the start of intervention

Quadriceps strength will be measured using an isokinetic dynamometer. Improvements in quadriceps strength from baseline to the end of intervention will be assessed and compared between groups.

次要结局

  • Changes in voluntary activation(Approximately 8 weeks after the start of intervention)

研究者

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

Chandramouli Krishnan

Director of Neuromuscular and Rehabilitation Robotics Laboratory

University of Michigan

研究点 (2)

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