Optimizing Clinical Outcomes for Patients With Chronic Ankle Instability Using Foot Intensive Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of recurrent ankle sprains
研究概览
简要总结
The overall objective of this study is to examine the effects of a 6-week foot-intensive rehabilitation (FIRE) program on lateral ankle sprain (LAS) re-injury rates, CAI symptoms, sensorimotor function, and self-reported disability in CAI patients.
详细描述
Lateral ankle sprains are one of the most common injuries sustained by the general population with the greatest rates in people who are physically active or service members. Approximately 40% of lateral ankle sprain patients develop chronic ankle instability (CAI) characterized by recurrent lateral ankle sprains, repetitive sensations of ankle "giving way", residual ankle sprain symptoms, and self-reported disability. Factors related to the development and progression of CAI has been thoroughly studied. However, few interventions have been developed which have successfully created long term reductions in re-injury rates, physical function, or health-related quality of life. Recent work by our research team has uncovered several novel motor and sensory deficits in the foot in patients with CAI. Deficits in foot function may contribute to the high re-injury rates, deficits in balance and strength, and diminished health-related quality of life commonly experienced by individuals with CAI. The investigators expect the additive effect of FIRE with components of the standard of care (balance training, strength training, and range of motion) will create the synergy needed to reduce future injuries (Aim 1), enhance physical function (Aim 2), and reduce self-reported disability in CAI patients (Aim 3).
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)
盲法说明
The investigators collecting the outcomes will be blinded to group allocation. Separate investigators will be used for intervention delivery and outcomes assessment.
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
- •Previous history of at least 1 ankle sprain and at least 2 episodes of "giving way" in the past 3 months.
- •Participants must answer "yes" to at least 5 questions on the Ankle Instability Instrument.
- •Score of 11 or higher on the Identification of Functional Ankle Instability (IdFAI).
- •Confirmed clinical presentation of CAI by a PT, AT, or MD.
排除标准
- •Sustained an ankle sprain in the previous four weeks or lower extremity neuromusculoskeletal injury other than to the ankle in the last 12 months.
- •History of surgery to the lower extremity.
- •Sustained a lower extremity fracture.
- •History of neurological disease, vestibular or visual disturbance or any other pathology that would impair their sensorimotor performance.
- •Current participation in a formal ankle joint rehabilitation program.
- •Sustained a concussion in the last 12 months.
- •Exhibit clinical examination characteristics of foot and ankle function which are consistent with conditions other than CAI (i.e. fracture, deformity).
研究组 & 干预措施
Standard of Care (SOC)
Participants will be randomized to receive standard of care rehabilitation (SOC) for a period of 6 weeks.The investigators will prospectively follow participants assigned to the SOC group for 24 months following completion of their assigned SOC intervention.
干预措施: Standard of Care Rehabilitation (SOC) (Behavioral)
Foot Intensive Rehabilitation (FIRE)
Participants will be randomized to receive foot intensive rehabilitation (FIRE) for a period of 6 weeks.The investigators will prospectively follow participants assigned to the FIRE group for 24 months following completion of their assigned SOC intervention.
干预措施: Foot Intensive Rehabilitation (FIRE) (Behavioral)
结局指标
主要结局
Number of recurrent ankle sprains
时间窗: 24 months
The ability of FIRE to attenuate the occurrence of ankle sprains compared to SOC rehabilitation will be determined through self-report. An ankle sprain will be operationally defined as an incident in which the rearfoot was inverted or supinated and resulted in a combination of swelling, pain, and time lost or modification of normal function for at least one day.
Severity of chronic ankle instability related symptoms
时间窗: 24 months
The ability of FIRE to attenuate the severity of related symptoms compared to SOC rehabilitation will be determined through the Cumberland Ankle Instability Tool. The Cumberland Ankle Instability Tool is a 9-item instrument used to identify self-reported impairments associated with CAI. This instrument is scored on a 0-30 scale, where lower scores represent greater severity of CAI related symptoms.
Frequency of episodes of the ankle giving way
时间窗: 24 months
The ability of FIRE to attenuate the number of episodes of the ankle giving way compared to SOC rehabilitation will be determined through self-reported occurrences per week in the past month. Episodes of giving way will be operationally defined for the subject as an incident in which the rearfoot suddenly rolled, felt weak, or lost stability; however, the individual did not sustain an ankle sprain and was able to continue with normal function.
次要结局
- Intrinsic Foot Muscle Activation(24 months)
- Ankle/Toe Strength(24 months)
- Plantar Cutaneous Sensation(24 months)
- Postural Control(24 months)
研究者
Matthew Hoch
Associate Professor, Principal Investigator
University of Kentucky