NMES and Chronic Ankle Instability

Chronic Ankle Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04322409
• Other study ID #: 20-042
• Status: Recruiting
• Phase: Phase 1
• Start date: November 1, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: March 2020
• Source: Appalachian State University
• Contact: Alan R Needle, Ph.D.
• Phone: 8282624039
• Email: needlear[@]appstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

H1: NMES will increase MEP size, H:M ratio, and decrease cortical silent period in individuals with CAI compared to the placebo treatment.

2. To determine if changes in neural excitability related to NMES or placebo treatment result in improved function (balance, muscle activation, outcomes) in participants with chronic ankle instability.

H2: Increased neural excitability will yield improved balance (postural stability indices), muscle activation, and patient-reported function.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: November 1, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

Subjects will be healthy subjects between the ages of 18-35. 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Ankle Instability
• Joint Instability

Intervention

Device:
• Neuromuscular Electrical Stimulation
5 sessions that consist of NMES over the peroneus longus muscle. This consists of a biphasic current with a phase duration of 240us delivered in a frequency of 75 pules per second, with a ramp-up time of 2-seconds, followed by a 50-s rest period (no stimulation). Each cycle will consist of 10 seconds of "on" time, and 50 seconds off, with 10 cycles being performed each session.
• Transcutaneous Electrical Nerve Stimulation
5 sessions that consist of 11-minutes of TENS over the skin of the peroneus longus. This consists of a biphasic current will be continuously applied at 100 pulses per second, with a phase duration of 100us for 10 minutes. The intensity will be turned up until the point the subjects feel the current (sensory threshold)

Locations

Country	Name	City	State
United States	Leon Levine Hall for Health Sciences	Boone	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Appalachian State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tibialis Anterior corticospinal excitability	Motor evoked potential size of tibialis anterior	Baseline, Week-2 (end of intervention), Week-4 (retention)
Primary	Soleus corticospinal excitability	Motor evoked potential size of soleus	Baseline, Week-2 (end of intervention), Week-4 (retention)
Primary	Peroneus Longus corticospinal excitability	Motor evoked potential size of peroneus longus	Baseline, Week-2 (end of intervention), Week-4 (retention)
Primary	Tibialis anterior reflexive excitability	H:M ratio of tibialis anterior	Baseline, Week-2 (end of intervention), Week-4 (retention)
Primary	Soleus reflexive excitability	H:M ratio of soleus	Baseline, Week-2 (end of intervention), Week-4 (retention)
Primary	Peroneus longus reflexive excitability	H:M ratio of peroneus longus	Baseline, Week-2 (end of intervention), Week-4 (retention)
Secondary	Dynamic postural stability index	Postural stability indices during a hop-to-stabilization task	Baseline, Week-2 (end of intervention), Week-4 (retention)
Secondary	Tibialis Anterior muscle activation	Mean electromyography from the tibialis anterior during a hop-to-stabilization task	Baseline, Week-2 (end of intervention), Week-4 (retention)
Secondary	Soleus muscle activation	Mean electromyography from the soleus during a hop-to-stabilization task	Baseline, Week-2 (end of intervention), Week-4 (retention)
Secondary	Peroneus Longus muscle activation	Mean electromyography from the peroneus during a hop-to-stabilization task	Baseline, Week-2 (end of intervention), Week-4 (retention)
Secondary	Ankle Eversion Strength	Isometric ankle eversion strength	Baseline, Week-2 (end of intervention), Week-4 (retention)
Secondary	Side-to-side Hop Test	Time to complete 10 hops over 30 cm lines	Baseline, Week-2 (end of intervention), Week-4 (retention)
Secondary	Patient-reported outcomes	Foot & Ankle ability measure, Disablement in the Physically Active Scale, Tampa Scale for Kinesiophobia	Baseline, Week-2 (end of intervention), Week-4 (retention)
Secondary	Foot & Ankle ability measure	Subjects complete FAAM questionnaire	Baseline, Week-2 (end of intervention), Week-4 (retention)
Secondary	Disablement in the Physically Active Scale	Subjects complete DPA questionnaire	Baseline, Week-2 (end of intervention), Week-4 (retention)
Secondary	Tampa Scale for Kinesiophobia	Subjects complete TSK-11 questionnaire	Baseline, Week-2 (end of intervention), Week-4 (retention)