Recruiting

NATION

Sponsor:

Womack Army Medical Center

Code:

NCT06527287

Conditions

Chronic Ankle Instability

Eligibility Criteria

Sex: All

Age: 18 - 44

Healthy Volunteers: Not accepted

Interventions

Neurocognitive Ankle Training for Instablity to Optimize Neuromusculoskeletal outcomes (NATION)

Evidence-Based

Study Details

Brief summary:

The purpose of this study is to examine the effectiveness of a novel ankle rehabilitation protocol on improving clinical and health outcomes in physically active individuals with chronic ankle instability (CAI). Our central hypothesis is NATION, a novel rehabilitation intervention that includes neurocognitive tasks, will improve overall health and function, and reduce lower extremity musculoskeletal injury in physically active individuals with CAI.

Conditions

Chronic Ankle Instability

Study ID

NCT06527287

Start date

Oct 13, 2025

Status verified date

Apr, 2026

Completion date

Jun 14, 2027

Anticipated

Primary completion date

Jun 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 44

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Physically active and engage in regular exercise/training
  • 18-44 years old (accounts for 86% of the individuals deployed in recent military conflicts)
  • Answer "yes" to Question 1 (i.e., have you ever sprained an ankle?) on the Ankle Instability Instrument
  • Answer "yes" to any four of the remaining Ankle Instability Instrument questions
  • Score <24 on the Cumberland Ankle Instability Tool
  • Report at least two episodes of the ankle "giving way" in the last six months
  • Access to a functional email address and internet for completion of health and Service member outcomes
  • Ability to provide informed consent

Exclusion Criteria:

  • Unable to read or comprehend the English language.
  • An ankle sprain within the last six (≤6) weeks that resulted in altered or missed physical activity for one or more (≥1) consecutive days.
  • History of ankle surgery.
  • History of lower extremity fracture in the last year or history of fracture that required fixation.
  • Any peripheral neuropathies or other health conditions/current musculoskeletal injuries that may influence balance.
  • Pregnant females (will be eligible for participation in the study after delivery of the baby and medical clearance by a qualified and licensed healthcare provider).

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NATION

NATION is a 6-week evidence-based CAI rehabilitation protocol that incorporates neurocognitive exercises. Participants will complete 18 unsupervised home sessions and 12 supervised sessions over the course of 6-weeks.

active comparator: Evidence-based

The Evidence-Based protocol will be identical to the intervention (i.e., NATION protocol), but the exercises will exclude the neurocognitive tasks. Participants will complete 18 unsupervised home sessions and 12 supervised sessions over the course of 6-weeks.

no intervention: Control

Participants assigned to the Control arm will be instructed to continue their normal routine.

Interventions

Neurocognitive Ankle Training for Instablity to Optimize Neuromusculoskeletal outcomes (NATION)

The NATION rehabilitation protocol will serve as the true intervention group. NATION is a 6-week evidence-based chronic ankle instability (CAI) rehabilitation protocol that incorporates neurocognitive exercises. Participants will complete up to 18 unsupervised home sessions and up to 12 supervised sessions. Treatment volume and exercises may vary based on participant progress and study team member guidance.

Evidence-Based

The Evidence-Based rehabilitation protocol will serve as the active comparator group. The Evidence-Based protocol will be similar to the intervention (i.e., NATION protocol), but the exercises will exclude the neurocognitive tasks. Participants assigned to the Evidence-Based protocol will complete up to 18 unsupervised home sessions and up to 12 supervised sessions over the course of 6-weeks. Treatment volume and exercises may vary based on participant progress.

Primary outcome measure

  • Ankle Strength [ Time Frame: Baseline, 6-weeks post-enrollment, & 6-months post-enrollment ]
  • Balance [ Time Frame: Baseline, 6-weeks post-enrollment, & 6-months post-enrollment ]
  • Motor Cognition [ Time Frame: Baseline, 6-weeks post-enrollment, & 6-months post-enrollment ]
  • Ankle Range of Motion [ Time Frame: Baseline, 6-weeks post-enrollment, & 6-months post-enrollment ]
  • Somatosensation [ Time Frame: Baseline, 6-weeks post-enrollment, & 6-months post-enrollment ]

Central Contacts and Locations

Central contacts

Megan H. Roach, PhD

910-907-1042megan.h.roach.civ@health.mil

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Matt C Hoch, PhD

859-218-0576matt.hoch@uky.edu

Womack Army Medical Center

Recruiting

Fort Bragg, North Carolina, United States, 28310

Contacts

Megan H Roach, PhD

910-849-7226megan.h.roach.civ@health.mil

More Information

Sponsor

Womack Army Medical Center

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • Chronic Ankle Instability; neurocognition; evidence-based rehabilitation; musculoskeletal outcomes; dual tasks

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Womack Army Medical Center on 2026-04-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.