NMES and Chronic Ankle Instability

NCT04322409 | Unknown Phase 1 FDA Device

• 1 other identifier: 20-042
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Tibialis Anterior corticospinal excitability

  Motor evoked potential size of tibialis anterior

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

• Soleus corticospinal excitability

  Motor evoked potential size of soleus

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

• Peroneus Longus corticospinal excitability

  Motor evoked potential size of peroneus longus

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

• Tibialis anterior reflexive excitability

  H:M ratio of tibialis anterior

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

• Soleus reflexive excitability

  H:M ratio of soleus

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

• Peroneus longus reflexive excitability

  H:M ratio of peroneus longus

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

Secondary Outcomes (10)

• Dynamic postural stability index

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

• Tibialis Anterior muscle activation

  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)

Study Arms (2)

NMES

EXPERIMENTAL

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

Device: Neuromuscular Electrical Stimulation

TENS

PLACEBO COMPARATOR

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

Device: Transcutaneous Electrical Nerve Stimulation

Interventions

Neuromuscular Electrical Stimulation DEVICE

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.

Also known as: NMES

NMES

Transcutaneous Electrical Nerve Stimulation DEVICE

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)

Also known as: TENS

TENS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Appalachian State University: lead

Study Sites (1)

Leon Levine Hall for Health Sciences

Boone, North Carolina, 28608, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 36634453 DERIVED

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Alan R Needle, Ph.D.

CONTACT

8282624039; needlear@appstate.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x3 Factorial; 2 groups by 3 time points

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: March 26, 2020
• Study Start: November 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: November 1, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)