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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Neurocognitive Ankle Training for Instablity to Optimize Neuromusculoskeletal outcomes (NATION)
Other interventionThe 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 interventionThe 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
Trial outcomes
Primary outcomes
Ankle Strength
Ankle plantarflexion, dorsiflexion, inversion, and eversion peak isometric force will be assessed with a hand-held dynamometer
Balance
Static and dynamic balance will be captured via a force plate and the Star Excursion Balance Test.
Motor Cognition
Motor-cognition will be measured via a choice reaction hop-to-stabilization test and a lower extremity reaction time task.
Ankle Range of Motion
Dorsiflexion range of motion will be measured via the Weight-Bearing Lunge test.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
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).
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.
Sponsors and contacts
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Womack Army Medical Center
Lead sponsor
University of Kentucky
Collaborator