Neurocognitive Ankle Training for Instability to Optimize Neuromusculoskeletal Outcomes (NATION)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Ankle Strength
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
结局指标
主要结局
Ankle Strength
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline, 6-weeks post-enrollment, & 6-months post-enrollment
Dorsiflexion range of motion will be measured via the Weight-Bearing Lunge test.
次要结局
- 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)
研究者
Megan Roach
Musculoskeletal Health Researcher
Womack Army Medical Center