Neurocognitive Ankle Training for Instability to Optimize Neuromusculoskeletal Outcomes (NATION)

NCT06527287 | Recruiting DMC

• 2 other identifiers: 24-19385MO240042
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Ankle Strength

  Ankle plantarflexion, dorsiflexion, inversion, and eversion peak isometric force will be assessed with a hand-held dynamometer

  Baseline, 6-weeks post-enrollment, & 6-months post-enrollment

• Balance

  Static and dynamic balance will be captured via a force plate and the Star Excursion Balance Test.

  Baseline, 6-weeks post-enrollment, & 6-months post-enrollment

• Motor Cognition

  Motor-cognition will be measured via a choice reaction hop-to-stabilization test and a lower extremity reaction time task.

  Baseline, 6-weeks post-enrollment, & 6-months post-enrollment

• Ankle Range of Motion

  Dorsiflexion range of motion will be measured via the Weight-Bearing Lunge test.

  Baseline, 6-weeks post-enrollment, & 6-months post-enrollment

• Somatosensation

  Somatosensation will be measured at the center of the heel using the 4-2-1 Semmes-Weinstein monofilament stepping algorithm.

  Baseline, 6-weeks post-enrollment, & 6-months post-enrollment

Secondary Outcomes (6)

• Fear-Avoidance Beliefs Questionnaire

  Baseline, 6-weeks post-enrollment, & 6-months post-enrollment

• Quick-Foot and Ankle Ability Measure

  Baseline, 6-weeks post-enrollment, & 6-months post-enrollment

• Defense and Veterans Pain Rating Scale

  Baseline, 6-weeks post-enrollment, & 6-months post-enrollment

• Modified Disablement in the Physically Active Scale

  Baseline, 6-weeks post-enrollment, & 6-months post-enrollment

• Confidence to Deploy

  Baseline, 6-weeks post-enrollment, & 6-months post-enrollment

Other Outcomes (2)

• NASA Task Load Index

  At the completion of each supervised rehabilitation session.

• Participant Satisfaction Questionnaire

  At the conclusion of the 6-week intervention for participants assigned to the NATION and Evidence-Based Practice protocols.

Study Arms (3)

NATION

EXPERIMENTAL

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.

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

Evidence-based

ACTIVE COMPARATOR

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.

Other: Evidence-Based

Control

NO INTERVENTION

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) OTHER

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.

NATION

Evidence-Based OTHER

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.

Evidence-based

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Physically active and engage in regular exercise/training
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Womack Army Medical Center: lead
• University of Kentucky: collaborator

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

RECRUITING

Study Officials

• Megan H Roach

  Womack Army Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan H. Roach, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Musculoskeletal Health Researcher

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 30, 2024
• Study Start: October 13, 2025
• Primary Completion (Estimated): June 14, 2027
• Study Completion (Estimated): June 14, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)