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临床试验/NCT04322409
NCT04322409Unknown1 期

The Role of Neuromuscular Electrical Stimulation (NMES) on Improving Function in Individuals With Chronic Ankle Instability

Appalachian State University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
1 期
入组人数
26
试验地点
2
主要终点
Tibialis Anterior corticospinal excitability

研究概览

简要总结

Chronic ankle instability is associated with changes in the nervous system that amount to increased difficulty in activating the stabilizing muscles of the ankle. Neuromuscular Electrical Stimulation involves using electricity to activate those muscles in bursts, and is commonly used to improve muscle function in those with ACL injury. This study will provide 5 treatments over 2 weeks in patients with Chronic Ankle Instability and determine if Electrical Stimulation can change neural excitability, balance, neuromuscular control, and perceived function in these individuals.

详细描述

Individuals with joint injuries, including ankle sprain and anterior cruciate ligament (ACL) injury have been observed to exhibit changes in central nervous system function that potentially predispose them for further injury (Needle et al. 2017). In ankle sprains, repeated sensations of rolling and giving-way known as chronic ankle instability (CAI) emerges in nearly 50 percent of those with a history of ankle sprain (Holland et al. 2019), with symptoms tied to changes in central nervous system function. As the understanding of these pathologies have expanded, researchers have begun to attempt to identify neuromodulatory interventions capable of addressing injury-induced maladaptive neuroplasticity, thus improving function (Bruce et al. 2020, In Press).

Among those with ACL injury, one of the most common interventions implemented to overcome muscle activation deficits includes neuromuscular electrical stimulation (NMES) (Lepley et al. 2015). This intervention is often used in the initial stages of post-surgical recovery to improve quadriceps function; however, it's use in other populations of joint injury (i.e. ankle sprain) is far more limited. Some previous research has looked at the effects of NMES on acute ankle sprains, as this is the timeframe in which muscle activation deficits would be most evident (Wainwright et al. 2019), but there is very limited evidence in those with CAI. It was potentially thought that activation deficits are less evident and strengthening may overcome these deficits in those with chronic injury; however, new insights have identified additional mechanisms by which NMES may be effective (Lepley et al. 2015). Aside from generating activation of a generally inactive muscle, NMES when performed at high intensities has been described to improve neuromuscular function through disinhibitory mechanisms. That is that increased somatosensation from the electrical stimulation raises the central nervous sytem's awareness of that muscle's activation, yielding decreased inhibition and ultimately increased neural excitability.

Our previous research using cortically-directed interventions demonstrated that improving neural excitability yielded better function in patients with chronic ankle instability (Bruce et al. 2020). This study will follow a similar framework; however, determining if these changes can be induced via a peripheral intervention. These findings have the ability to reframe the current treatment for CAI.

We are pursuing the following 2 specific aims:

  1. To determine if NMES changes neural excitability (MEP size, H:M ratio, silent period) compared to a placebo treatment in participants with chronic ankle instability.

研究设计

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

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

  • Subjects will be healthy subjects between the ages of 18-
  • The primary inclusion criteria for this study is the presence of chronic ankle instability (CAI). According to guidelines from the International Ankle Consortium, this means subjects will report having a history of one or more ankle sprains (the first >1 year ago), and repeated sensations of giving-way as measured by a score >10 on the Identification of Functional Ankle Instability instrument (IDFAI).

排除标准

  • History of fracture or surgery to the legs
  • Injury to the lower legs within 3 months prior to reporting for testing that resulted in modified physical activity.
  • Currently involved in an ankle rehabilitation program.
  • Failing to meet standards for the safe practice of transcranial magnetic stimulation and transcranial direct current stimulation (See questionnaire). Briefly, this includes personal or family history of seizure or epilepsy; current medication use that raises risk of seizure; implanted metal, medication devices, etc.; history of brain or heart surgery; and sensitivity of the scalp or skin.

结局指标

主要结局

Tibialis Anterior corticospinal excitability

时间窗: Baseline, Week-2 (end of intervention), Week-4 (retention)

Motor evoked potential size of tibialis anterior

Soleus corticospinal excitability

时间窗: Baseline, Week-2 (end of intervention), Week-4 (retention)

Motor evoked potential size of soleus

Peroneus Longus corticospinal excitability

时间窗: Baseline, Week-2 (end of intervention), Week-4 (retention)

Motor evoked potential size of peroneus longus

Tibialis anterior reflexive excitability

时间窗: Baseline, Week-2 (end of intervention), Week-4 (retention)

H:M ratio of tibialis anterior

Soleus reflexive excitability

时间窗: Baseline, Week-2 (end of intervention), Week-4 (retention)

H:M ratio of soleus

Peroneus longus reflexive excitability

时间窗: Baseline, Week-2 (end of intervention), Week-4 (retention)

H:M ratio of peroneus longus

次要结局

  • Dynamic postural stability index(Baseline, Week-2 (end of intervention), Week-4 (retention))
  • Soleus muscle activation(Baseline, Week-2 (end of intervention), Week-4 (retention))
  • Peroneus Longus muscle activation(Baseline, Week-2 (end of intervention), Week-4 (retention))
  • Ankle Eversion Strength(Baseline, Week-2 (end of intervention), Week-4 (retention))
  • Side-to-side Hop Test(Baseline, Week-2 (end of intervention), Week-4 (retention))
  • Patient-reported outcomes(Baseline, Week-2 (end of intervention), Week-4 (retention))
  • Foot & Ankle ability measure(Baseline, Week-2 (end of intervention), Week-4 (retention))
  • Disablement in the Physically Active Scale(Baseline, Week-2 (end of intervention), Week-4 (retention))
  • Tampa Scale for Kinesiophobia(Baseline, Week-2 (end of intervention), Week-4 (retention))
  • Tibialis Anterior muscle activation(Baseline, Week-2 (end of intervention), Week-4 (retention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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