Recruiting
Phase 1

Electrical Stimulation

Sponsor:

Appalachian State University

Code:

NCT04322409

Conditions

Chronic Ankle Instability

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

Interventions

Neuromuscular Electrical Stimulation

Transcutaneous Electrical Nerve Stimulation

Study Details

Brief 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.

Conditions

Chronic Ankle Instability

Study ID

NCT04322409

Start date

Nov 1, 2019

Status verified date

Mar, 2020

Completion date

Nov 1, 2020

Anticipated

Primary completion date

Jun 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

26 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NMES

The experimental treatment of Neuromuscular Electrical Stimulation over the Peroneus Longus.

placebo comparator: TENS

The placebo treatment of Transcutaneous Electrical Nerve Stimulation over the same region as the peroneus longus

Interventions

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)

Primary outcome measure

  • Tibialis Anterior corticospinal excitability [ Time Frame: Baseline, Week-2 (end of intervention), Week-4 (retention) ]
  • Soleus corticospinal excitability [ Time Frame: Baseline, Week-2 (end of intervention), Week-4 (retention) ]
  • Peroneus Longus corticospinal excitability [ Time Frame: Baseline, Week-2 (end of intervention), Week-4 (retention) ]
  • Tibialis anterior reflexive excitability [ Time Frame: Baseline, Week-2 (end of intervention), Week-4 (retention) ]
  • Soleus reflexive excitability [ Time Frame: Baseline, Week-2 (end of intervention), Week-4 (retention) ]
  • Peroneus longus reflexive excitability [ Time Frame: Baseline, Week-2 (end of intervention), Week-4 (retention) ]

Central Contacts and Locations

Central contacts

Alan R Needle, Ph.D.

8282624039needlear@appstate.edu

Locations

Leon Levine Hall for Health Sciences

Recruiting

Boone, North Carolina, United States, 28608

Contacts

Alan R Needle

828-262-4039needlear@appstate.edu

More Information

Sponsor

Appalachian State University

Last update posted

Mar 26, 2020

Last verified

Mar, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Appalachian State University on 2020-03-26.