Neurocognitive Ankle Training for Instability to Optimize Neuromusculoskeletal Outcomes (NATION)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Womack Army Medical Center
- Enrollment
- 180
- Locations
- 2
- Primary Endpoint
- Ankle Strength
Study Overview
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.
Detailed Description
Military personnel and physically active civilians are particularly vulnerable to ankle sprains and subsequent chronic ankle instability (CAI). CAI is a complex neuromusculoskeletal condition characterized by recurring ankle sprains, episodes of instability, ongoing pain, and functional disability that results in activity limitations and participation or duty restrictions. Despite mitigation efforts, ankle sprains continue to occur frequently and commonly progress to CAI.
CAI is associated with deficiencies in neurocognitive function (i.e., the ability to think, reason, and react) and increased instability during dual-tasks. These neurocognitive deficiencies identify a novel impairment that should be addressed during CAI rehabilitation. However, current evidence-based protocols for CAI lack dual-task exercises that incorporate visual and cognitive components simultaneously. Thus, training neurocognitive function simultaneously with traditional CAI impairments, may improve outcomes and mitigate episodes of giving way, recurrent ankle sprains, and subsequent lower extremity Musculoskeletal Injuries (MSKIs), culminating in improved Service member and civilian outcomes, continued involvement in physical activity, and active duty status retention. Hence, the overall objective of the Neurocognitive Ankle Training for Instability to Optimize Neuromusculoskeletal outcomes (NATION) study, is to examine the effectiveness of a novel ankle rehabilitation protocol on improving clinical and health outcomes in physically active individuals with CAI.
The overall objective will be achieved by the following Specific Aims:
Specific Aim 1: Determine the effectiveness of NATION on improving clinical outcomes compared to an evidence-based rehabilitation intervention and control arm in physically active individuals with CAI at 6-weeks and 6-months post-enrollment.
Hypothesis 1: Our novel CAI rehabilitation protocol will result in improved range of motion, postural control, strength, somatosensation, lower extremity function, and motor-cognition as compared to an evidence-based protocol and control arm.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 44 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
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.
Intervention: Evidence-Based (Other)
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.
Intervention: Neurocognitive Ankle Training for Instablity to Optimize Neuromusculoskeletal outcomes (NATION) (Other)
Control
Participants assigned to the Control arm will be instructed to continue their normal routine.
Outcomes
Primary Outcomes
Ankle Strength
Time Frame: Baseline, 6-weeks post-enrollment, & 6-months post-enrollment
Ankle plantarflexion, dorsiflexion, inversion, and eversion peak isometric force will be assessed with a hand-held dynamometer
Somatosensation
Time Frame: Baseline, 6-weeks post-enrollment, & 6-months post-enrollment
Somatosensation will be measured at the center of the heel using the 4-2-1 Semmes-Weinstein monofilament stepping algorithm.
Balance
Time Frame: Baseline, 6-weeks post-enrollment, & 6-months post-enrollment
Static and dynamic balance will be captured via a force plate and the Star Excursion Balance Test.
Motor Cognition
Time Frame: Baseline, 6-weeks post-enrollment, & 6-months post-enrollment
Motor-cognition will be measured via a choice reaction hop-to-stabilization test and a lower extremity reaction time task.
Ankle Range of Motion
Time Frame: Baseline, 6-weeks post-enrollment, & 6-months post-enrollment
Dorsiflexion range of motion will be measured via the Weight-Bearing Lunge test.
Secondary Outcomes
- Defense and Veterans Pain Rating Scale(Baseline, 6-weeks post-enrollment, & 6-months post-enrollment)
- 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)
- 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)
- Musculoskeletal Injury Questionnaire(Baseline, 6-weeks post-enrollment, & 6-months post-enrollment)
Investigators
Megan Roach
Musculoskeletal Health Researcher
Womack Army Medical Center