Smartphone for Assessing Balance in Patients With Ankle Instability

Study Overview
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Brief Summary
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This study aims at investigating the validity and reliability of a smartphone application MyAnkle: in assessing the balance component of postural control in patients with chronic ankle instability (CAI).

Detailed Description
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Lateral ankle sprain (LAS) is a common injury in athletic and regular activities; with an incidence of 7 per 1000 exposure. After LAS, residual symptoms may persist leading to chronic ankle instability (CAI). This instability is believed to arise from dysfunctional postural control, defective proprioception, weak muscles, or reduced ankle range of motion (ROM).Thus, assessment of postural control is essential for proper clinical decision-making and treatment selection. With advances in technology, smartphone has been introduced as an assessment tool for the musculoskeletal system. For example, it was used in assessment of ROM and mobility in stroke patients and frail elderly conditions. Further, it was used to assess balance and falling risk in those population. In addition, it was used to assess balance in healthy and participants with chronic ankle sprain. These studies proved that smartphone is a valid and reliable tool that is light in weight and inexpensive. Yet, these studies have some methodological concerns. For example, the application was not validated against gold standard or was validated only in healthy volunteers rather than in patients with musculoskeletal dysfunction. Further, a few of these studies did not establish the application discriminative validity between patients and healthy controls. Thus, this study will try to answer the following question: Is smartphone application a valid and reliable tool to assess balance in patients with CAI compared to gold standards?

Official Title
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Validity and Reliability of a Smartphone Application for Assessing Balance in Patients With Chronic Ankle Instability

Conditions
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Chronic Ankle Instability

Intervention / Treatment
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* Diagnostic Test: Smartphone MyAnkle balance application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult males and females aging from 18 to 35 years old. Referred with a confirmed diagnosis of CAI, with a Cumberland Ankle Instability tool score lower than 27 points. Had a recurrent sprain within the previous year. Exclusion Criteria: History of major surgery of lower limb or spine. History of ankle fracture or any other lower limb fracture in the past 2 years. History of lower limb injury 3 months prior to study. Presence of problems that affect balance performance as visual or vestibular deficits, neurologic disease, or cerebral concussions during the past 3 months. Being currently enrolled in a balance training rehabilitation program. Weakness of lower limb musculatures or trunk upon screening muscle testing by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with CAI<br>Patients referred with a confirmed diagnosis of CAI, with a Cumberland Ankle Instability tool score lower than 27 points. Patients should have had a recurrent sprain within the previous year. Patients will have their balance assessed using the Myankle smartphone application simultaneously with Biodex balance system assessment. | Diagnostic Test: Smartphone MyAnkle balance application<br>* Balance will be assessed simultaneously using MyAnkle application and the Biodex balance system. The smartphone will be fixed to the middle of the shin with an armband. Participants will assume a single leg stance on each side under two conditions: eyes opened and closed. Testing will be done at three levels of difficulty; least difficult (level 8), moderate (level 6) and severe difficult (level 4). A conditioning trial for each level will be given for 30 seconds. Further, a 2-minute rest between tests will be given. During the testing, participants should not touch the ground or stance limb by other limb nor to grasp the handrail. Participants will repeat the same testing in two separate sessions, with one-week interval in between.<br>* Other names: Biodex Balance system;|
| Healthy participants<br>Healthy participants who are not complaining of pain and have not be exposed to trauma, injury or undergone surgery for the lower quadrant of the body. Participants will have their balance assessed using the MyAnkle smartphone application simultaneously with Biodex balance system assessment. | Diagnostic Test: Smartphone MyAnkle balance application<br>* Balance will be assessed simultaneously using MyAnkle application and the Biodex balance system. The smartphone will be fixed to the middle of the shin with an armband. Participants will assume a single leg stance on each side under two conditions: eyes opened and closed. Testing will be done at three levels of difficulty; least difficult (level 8), moderate (level 6) and severe difficult (level 4). A conditioning trial for each level will be given for 30 seconds. Further, a 2-minute rest between tests will be given. During the testing, participants should not touch the ground or stance limb by other limb nor to grasp the handrail. Participants will repeat the same testing in two separate sessions, with one-week interval in between.<br>* Other names: Biodex Balance system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concurrent validity of smartphone MyAnkle application | Correlation between the score of MyAnkle smartphone balance application and stability score of the Biodex balance system. | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrarater reliability of smartphone measurements | same investigator will repeat balance assessment using MyAnkle smartphone balance application | one week | 
| Interrater reliability of smartphone measurements | Three investigators will assess balance using the MyAnkle smartphone application | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balance, Smartphone, Validity, Reliability, chronic ankle instability