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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-44
SponsorWomack Army Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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

    Other intervention

    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.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: NATIONExperimental treatment 1 intervention
Group B: Evidence-basedActive comparator 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Ankle Strength

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

Time frame
Baseline, 6-weeks post-enrollment, & 6-months post-enrollment
2

Balance

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

Time frame
Baseline, 6-weeks post-enrollment, & 6-months post-enrollment
3

Motor Cognition

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

Time frame
Baseline, 6-weeks post-enrollment, & 6-months post-enrollment
4

Ankle Range of Motion

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

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

Secondary outcomes

1

Fear-Avoidance Beliefs Questionnaire

Injury-related fear will be captured on the ankle-specific Fear-Avoidance Beliefs Questionnaire (FABQ). The FABQ is a 16-item questionnaire designed to assess fear-avoidance beliefs regarding physical activity and work. FABQ total scores range from 0 to 66 with higher scores indicating greater fear.

Time frame
Baseline, 6-weeks post-enrollment, & 6-months post-enrollment
2

Quick-Foot and Ankle Ability Measure

Foot and ankle function will be measured via the Quick Foot and Ankle Ability Measure (Quick-FAAM). A 12-item scale, the Quick-FAAM is comprised of two subscales: Activities of Daily Living (FAAM-ADL) and Sport (FAAM-Sport). All scores are transformed into percentages, with 100% representing no functional loss.

Time frame
Baseline, 6-weeks post-enrollment, & 6-months post-enrollment
3

Defense and Veterans Pain Rating Scale

Quality of life will be assessed via the modified Disablement in the Physically Active Scale (mDPA). The mDPA is a 16-item generic outcome instrument designed by athletic trainers for physically active individuals. The mDPA scores range from 0 to 64 with higher scores indicating greater disablement.

Time frame
Baseline, 6-weeks post-enrollment, & 6-months post-enrollment
4

Modified Disablement in the Physically Active Scale

Quality of life will be assessed via the modified Disablement in the Physically Active Scale (mDPA). The mDPA is a 16-item generic outcome instrument designed by athletic trainers for physically active individuals. The mDPA scores range from 0 to 64 with higher scores indicating greater disablement.

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

Other outcomes

1

NASA Task Load Index

All six NASA Task Load Index dimensions will serve as an outcome of interest on a scale of 0 (very low) to 100 (very high).

Time frame
At the completion of each supervised rehabilitation session.
2

Participant Satisfaction Questionnaire

To assess participant satisfaction with the interventions participants will complete the Participant Satisfaction Questionnaire. Each question is scored on a Likert scale of 1 to 5.

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

Sponsors and contacts

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Womack Army Medical Center

Lead sponsor

University of Kentucky

Collaborator