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临床试验/NCT05519345
NCT05519345已完成不适用

Conditioning Brain Responses for Modulating Corticospinal Excitability After ACL Reconstruction

University of Michigan2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年12月28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
22
试验地点
2
主要终点
Changes in corticospinal excitability

研究概览

简要总结

The purpose of this study is to examine if the changes in corticospinal function that accompany ACL reconstruction can be improved through a form of mental coaching and encouragement, known as operant conditioning.

详细描述

It is theorized reduced corticospinal excitability contributes to quadriceps dysfunction after knee injury and joint disease. Current rehabilitation does not directly target the alterations in corticospinal excitability, which may limit recovery. Operant conditioning is an emerging approach capable of increasing corticospinal excitability by directly targeting the corticospinal pathways. However, it remains to be determined whether operant conditioning of the corticospinal pathway may improve corticospinal function after knee trauma. Therefore, this study will evaluate the ability of operant up-conditioning of the corticospinal pathway to improve corticospinal function after ACL reconstruction.

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
14 Years 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • aged 14-45 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 on the contralateral leg
  • have undergone previous major surgery to the contralateral 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 seizure
  • have a history of repeated fainting spells

结局指标

主要结局

Changes in corticospinal excitability

时间窗: Baseline (before the start of the intervention) and post-intervention (approximately 2 weeks after baseline)

Corticospinal excitability will be measured using transcranial magnetic stimulation at baseline and post-intervention and will be compared between groups.

次要结局

未报告次要终点

研究者

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

Riann Palmieri-Smith

Professor

University of Michigan

研究点 (2)

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