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Chronic Ankle InstabilityPhase 1NCT04322409

NMES and Chronic Ankle Instability

A Phase 1 study testing Neuromuscular Electrical Stimulation and Transcutaneous Electrical Nerve Stimulation in people with Chronic Ankle Instability, run by Appalachian State University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Chronic Ankle Instability
What is being tested?
Neuromuscular Electrical Stimulation and Transcutaneous Electrical Nerve Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteUnited States
Study dates
1 Nov 2019to 1 Nov 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Alan R Needle, Ph.D. contact

8282624039

needlear@appstate.edu

United States1 site, 1 recruiting
  • Leon Levine Hall for Health Sciences

    Boone, North Carolina, 28608

    Alan R Needle, 828-262-4039, needlear@appstate.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
Neuromuscular Electrical Stimulation, Transcutaneous Electrical Nerve Stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular Electrical StimulationDevice

    Also called NMES

    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 StimulationDevice

    Also called TENS

    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)

Study groups in NCT04322409
Study groupRoleWhat they receive
NMESExperimentalThe experimental treatment of Neuromuscular Electrical Stimulation over the Peroneus Longus.
Receives: Device: Neuromuscular Electrical Stimulation
TENSPlacebo comparatorThe placebo treatment of Transcutaneous Electrical Nerve Stimulation over the same region as the peroneus longus
Receives: Device: Transcutaneous Electrical Nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tibialis Anterior corticospinal excitability

    Motor evoked potential size of tibialis anterior

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

  2. Soleus corticospinal excitability

    Motor evoked potential size of soleus

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

  3. Peroneus Longus corticospinal excitability

    Motor evoked potential size of peroneus longus

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

  4. Tibialis anterior reflexive excitability

    H:M ratio of tibialis anterior

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

  5. Soleus reflexive excitability

    H:M ratio of soleus

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

  6. Peroneus longus reflexive excitability

    H:M ratio of peroneus longus

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

Secondary outcomes (10)
  1. Dynamic postural stability index

    Postural stability indices during a hop-to-stabilization task

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

  2. Tibialis Anterior muscle activation

    Mean electromyography from the tibialis anterior during a hop-to-stabilization task

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

  3. Soleus muscle activation

    Mean electromyography from the soleus during a hop-to-stabilization task

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

  4. Peroneus Longus muscle activation

    Mean electromyography from the peroneus during a hop-to-stabilization task

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

  5. Ankle Eversion Strength

    Isometric ankle eversion strength

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

  6. Side-to-side Hop Test

    Time to complete 10 hops over 30 cm lines

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

  7. Patient-reported outcomes

    Foot \& Ankle ability measure, Disablement in the Physically Active Scale, Tampa Scale for Kinesiophobia

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

  8. Foot & Ankle ability measure

    Subjects complete FAAM questionnaire

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

  9. Disablement in the Physically Active Scale

    Subjects complete DPA questionnaire

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

  10. Tampa Scale for Kinesiophobia

    Subjects complete TSK-11 questionnaire

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2020
  2. Study start1 Nov 2019
  3. Primary completion30 Jun 2020 (estimated)
  4. Study completion1 Nov 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
2x3 Factorial; 2 groups by 3 time points
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04322409
Sponsor's protocol ID
20-042
Status last verified
Mar 2020
First submitted
7 Jan 2020
Last updated
26 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Needle AR, Tinsley JE, Cash JJ, Koeval BK, Barton JA, Howard JS. The effects of neuromuscular electrical stimulation to the ankle pronators on neural excitability & functional status in patients with chronic ankle instability. Phys Ther Sport. 2023 Mar;60:1-8. doi: 10.1016/j.ptsp.2022.12.001. Epub 2022 Dec 9.

    PubMed 36634453

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Neuromuscular Electrical Stimulation and Transcutaneous Electrical Nerve Stimulation in people with Chronic Ankle Instability, run by Appalachian State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alan R Needle, Ph.D. (8282624039, needlear@appstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tibialis Anterior corticospinal excitability (time frame: Baseline, Week-2 (end of intervention), Week-4 (retention)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04322409, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.

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