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临床试验/NCT04504344
NCT04504344已完成1 期

Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction

Arcadia University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年9月15日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
quadriceps rate of torque development

研究概览

简要总结

Quadriceps muscle dysfunction persists for years after anterior cruciate ligament reconstruction (ACLR) and is related to poor self-reported outcomes, altered movement patterns and joint loading associated with post-traumatic knee osteoarthritis (OA), and higher risk of reinjury. Emerging evidence indicates that central drive (pathway from the brain to the muscle of interest, i.e corticospinal excitability) to the quadriceps muscle is reduced as early as 2 weeks after surgery and can persist for years after ACLR, meaning that current rehabilitation strategies may not be addressing potential maladaptive changes in central drive. Anodal tDCS is a neurostimulation technology that increases brain excitability (i.e. central drive) and has the potential to address alterations in central drive and quadriceps muscle performance. The purpose of this study is twofold: 1) to determine the effects of anodal tDCS on central drive and quadriceps muscle performance in patients after ACLR, and 2) determine the relationship between central drive and quadriceps muscle performance in patients after ACLR. Central drive will be defined by two measures: 1) active motor thresholds, and 2) slope of a stimulus response curve. Quadriceps muscle performance will be defined by two measures: 1) isometric quadriceps strength, and 2) rate of torque development (RTD). For purpose 1 the investigators hypothesize that measures of central drive and quadriceps muscle performance will increase with administration of active anodal tDCS compared to no change with sham tDCS. For purpose 2 the investigators hypothesize that both measures of central drive will be associated with both measures of quadriceps performance, with a stronger association between central drive and RTD. Following a cross-over design patients 3-6 months from ACLR will receive active and sham anodal tDCS at different sessions separated by 7-10 days while they ride a stationary bike for 20 minutes. Bike position and intensity will be standardized for all patients to maximize quadriceps activity. Findings from this study will expand our basic science knowledge on how tDCS effects different aspects of corticospinal excitability and quadriceps strength, and lead to subsequent studies to determine the effects of multiple sessions of tDCS on corticospinal excitability and quadriceps muscle performance in patients recovering from ACLR.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Underwent primary ACL reconstruction within 3-6 months

排除标准

  • multiple ligament reconstruction
  • osteo-chondral procedures
  • any previous lower extremity surgery
  • previous ACL injury
  • Metal or implants in the head or neck
  • history of neurological disease, seizures, severe migraines, and concussion within the last 6 months

结局指标

主要结局

quadriceps rate of torque development

时间窗: 3-6 months after ACL Reconstruction

Nm/s

Corticospinal excitability - active motor threshold

时间窗: 3-6 months after ACL Reconstruction

percent maximal stimulator output

isometric quadriceps torque

时间窗: 3-6 months after ACL Reconstruction

Nm

Corticospinal excitability - slope of the stimulus response curve

时间窗: 3-6 months after ACL Reconstruction

motor evoked potential/percent active motor threshold

次要结局

未报告次要终点

研究者

发起方
Arcadia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ryan Zarzycki

Assistant Professor Department of Physical Therapy

Arcadia University

研究点 (2)

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