Effects Of Rehabilitation Incorporating Gait Training On Clinical Measures Associated With Chronic Ankle Instability

Study Overview
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Brief Summary
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This is a randomized controlled trial (RCT) regarding the conservative treatment of chronic ankle instability (CAI) with an impairment based rehabilitation program. Individuals with CAI have deficits in neuromuscular control and altered gait patterns. Ankle destabilization shoes are used clinically and may improve neuromuscular control by increasing lower extremity muscle activation, which may improve gait patterns. The investigators' purpose is to determine whether a 4-week rehabilitation program that includes ankle destabilization shoes (experimental) has beneficial effects on self-reported function and ankle gait kinematics compared to traditional rehabilitation without destabilization shoes (control) in CAI patients. In addition, the investigators will compare ankle strength and balance between CAI patients and healthy individuals with no history of ankle injury prior to the 4-week rehabilitation. The investigators hypothesize the experimental group will have greater improvement in self-reported function and frontal and sagittal plane kinematics during walking compared to the control group. In addition, the investigators hypothesize that patients with CAI will have a decrease in ankle strength and balance when compared to healthy individuals. The design is a single-blinded randomized controlled trial. Forty CAI patients will complete baseline self-reported function questionnaires and walking gait trials and then be randomized into control and experimental groups. Both groups will complete 4-weeks of supervised rehabilitation with or without destabilization shoes and then repeat the questionnaires and walking trials.

Official Title
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Effects Of Rehabilitation Incorporating Gait Training On Clinical Measures Associated With Chronic Ankle Instability

Conditions
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Chronic Ankle Instability

Intervention / Treatment
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* Other: Traditional Instability Tools
* Other: Ankle Destabilization Shoes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CAI with a history of recurrent ankle sprains, with the first sprain occurring longer than 12 months ago. Participants will have lingering symptoms, and disability, but have not actively sought treatment for their CAI All participants will be physically active: Participating in some form of physical activity for at least 20 min per day, three times per week. Exclusion Criteria: Neurological or vestibular disorders affecting balance Currently seeking medical care for CAI History of prior ankle surgery History of ankle sprain within the past 6 weeks History of ankle fracture Diabetes mellitus Current self-reported disability due to lower extremity pathology that may adversely affect neuromuscular function Lumbosacral radiculopathy Pregnant Soft tissue disorders including Marfan's syndrome and Ehlers-Dandros syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Instability Tools<br>Participants will use traditional instability tools during the impairment-based rehabilitation intervention. | Other: Traditional Instability Tools<br>* Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools.<br>|
| Experimental: Ankle destabilization shoes<br>Participants will use ankle destabilization shoes during the impairment-based rehabilitation intervention. | Other: Ankle Destabilization Shoes<br>* Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use ankle destabilization shoes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in self-reported function as measured by the Foot and Ankle Ability Measure questionnaire | Scores range from 100%(no decrease in function) to 0%(complete loss of function) | after 4-weeks of rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in ankle range of motion measured in degrees | Four different ankle ranges of motion will be measured using a bubble inclinometer | after 4-weeks of rehabilitation | 
| Changes from baseline in ankle maximum voluntary isometric strength | Ankle maximum voluntary isometric strength will be measured during five different ankle positions using a hand-held dynamometer. | after 4-weeks of rehabilitation | 
| Changes from baseline in balance | Static balance will be measured by participants standing on one limb on a forceplate to measure the participant's center of pressure. | after 4-weeks of rehabilitation | 
| Changes from baseline in lower extremity electromyography during ankle maximal voluntary isometric strength testing | Lower extremity electormyography during maximal isometric strength testing will be measured using surface EMG electrodes over the peroneus brevis, peroneus longus, anterior tibialis, and medial gastrocnemius muscles. | after 4-weeks of rehabilitation | 
| Changes from baseline in lower extremity electromyography during balance | Lower extremity electormyography during balance testing will be measured using surface EMG electrodes over the peroneus brevis, peroneus longus, anterior tibialis, and medial gastrocnemius muscles. | after 4-weeks of rehabilitation | 
| Changes from baseline in lower extremity kinematics during walking | Ankle, knee, and hip motion during walking measured by a 3D motion capture system | after 4-weeks of rehabilitation | 
| Changes from baseline in lower extremity kinetics during walking | Ankle, knee, and hip moments during walking measured by a 3D motion capture system | after 4-weeks of rehabilitation | 
| Changes from baseline in lower extremity surface electromyography during walking | Lower extremity electormyography during walking will be measured using surface EMG electrodes over the peroneus brevis, peroneus longus, anterior tibialis, and medial gastrocnemius muscles. | after 4-weeks of rehabilitation |