Neurocognitive Ankle Training for Instability to Optimize Neuromusculoskeletal Outcomes (NATION)
NCT Number: NCT06527287
Acronym: NATION
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Ankle Instability
Interventions: OTHER: Neurocognitive Ankle Training for Instablity to Optimize Neuromusculoskeletal outcomes (NATION)|OTHER: Evidence-Based
Sponsor: Womack Army Medical Center
Collaborators: University of Kentucky
Sex: ALL
Age: ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-06-14

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.

Primary Outcome Measures: 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 Outcome Measures: Fea-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., Baseline, 6-weeks post-enrollment, & 6-months post-enrollment|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., Baseline, 6-weeks post-enrollment, & 6-months post-enrollment|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., Baseline, 6-weeks post-enrollment, & 6-months post-enrollment|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., Baseline, 6-weeks post-enrollment, & 6-months post-enrollment|Confidence to Deploy, Participants will rate their ability to travel to/within a combat zone, carry/wear/use all required equipment and/or weapon, and perform required military duties for the duration of a six month deployment on a scale of 0 (not at all confident) to 100 (fully confident)., Baseline, 6-weeks post-enrollment, & 6-months post-enrollment|Musculoskeletal Injury Questionnaire, Participants will self-report lifetime ankle sprains and any previous lower extremity MSKIs sustained 12-months prior to enrollment into the study. Participants will also self-report number of episodes of the ankle giving way and any new lower extremity MSKIs at 6-weeks and 6-months post-enrollment., Baseline, 6-weeks post-enrollment, & 6-months post-enrollment
Other Outcome Measures: 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)., At the completion of each supervised rehabilitation session.|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., At the conclusion of the 6-week intervention for participants assigned to the NATION and Evidence-Based Practice protocols.