Evaluation for the Effect of Smartphone Based Training on Chronic Ankle Instability Subjects

Study Overview
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Brief Summary
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This study aims to verify the training effect of smartphone-based training for chronic ankle instability(CAI) subjects. By randomizing subjects to App training group, clinical training group and control group, the training effect will be compared among groups.

Detailed Description
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Postural control ability may be damaged after ankle sprains. Poor postural control ability is the risk factors of the ankle sprain, forming a vicious circle of recurrent sprains. Proper and early assessment is the key to breaking down the circle. Smartphones have been utilized in the medical field. With built-in sensors, utilizing smartphones as assessment tools can provide quantitative data of postural control performance. This study aims to verify the training effect of smartphone-based training for CAI subjects. CAI subjects were recruited and randomly assigned to App training group, Home training group and control group, receiving 6 weeks of intervention. Pre-test was conducted before the intervention, and the post-test was conducted after the 6-week intervention. The follow up assessment was conducted 4 weeks after the post-test.

Official Title
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Development of a Smartphone-based System for Training Subjects With Chronic Ankle Instability and Training Effect Evaluation

Conditions
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Chronic Ankle Instability

Intervention / Treatment
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* Other: App Balance training
* Other: Home Balance training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one ankle sprain history At least 2 times of sprain and feeling unstable Diagnosed as functional ankle instability Full recovered from injury Cumberland Ankle Instability Tool<24 Ankle Instability Instrument >5 yes Identification of Functional Ankle Instability >11 Exclusion Criteria: Diagnosis as mechanical instability Neurological deficits Lower extremity injury within the past 6 wk History of lower-extremity surgery Other conditions known to affect balance

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: App training group<br>Subjects in App training group will receive App Balance training via smartphone application. | Other: App Balance training<br>* Training specially designed for balance ability of chronic ankle instability groups. Guidance through smartphone application as home program.<br>|
| Active Comparator: Home training group<br>Subjects in Home training group will receive Home Balance training advised by physical therapist. | Other: Home Balance training<br>* Training specially designed for balance ability of chronic ankle instability groups. Follow the usual home program provided in clinics.<br>|
| No Intervention: Control group<br>Control group will receive only education of ankle injury prevention related information. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural sway measurement | Using smartphone application and force plate to record the postural sway during single leg stance. | 30 seconds | 
| Star Excursion Balance Test | To assess the dynamic balance ability of subjects. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot and Ankle Outcome Score | An ankle function assessment tool, with 5 dimensions includes symptoms, pain, activity, function and sport, and quality of life. The scale score ranges from 0% to 100%, the higher the percentage, the better ankle function. Subjects answer the questions by choosing different choices that describe their condition the best. The total score will be summed up and calculated as percentage. | 5 minutes | 
| Foot and Ankle Ability Measure-sport subscale | An ankle function assessment tool. The scale score ranges from 0% to 100%, the higher the percentage, the better ankle function. Subjects answer the 7 questions by choosing different degree of difficulty to accomplish the activities. The total score will be summed up and calculated as percentage. | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic ankle instability, Smartphone