Smartphone for Assessing Balance in Patients With Ankle Instability

Completed

• Conditions: Chronic Ankle Instability
• Interventions: Diagnostic Test: Smartphone "MyAnkle" balance application

• Registration Number: NCT03598985
• Lead Sponsor: Cairo University

Brief Summary

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

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?

Study Timeline

• Study First Submitted: 2018-07-16
• Study Start: 2018-07-23
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-07-26
• Primary Completion: 2019-02-27
• Study Completion: 2019-05-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-22
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

1. Adult males and females aging from 18 to 35 years old.
2. Referred with a confirmed diagnosis of CAI, with a Cumberland Ankle Instability tool score lower than 27 points.
3. Had a recurrent sprain within the previous year.

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Exclusion Criteria

1. History of major surgery of lower limb or spine.
2. History of ankle fracture or any other lower limb fracture in the past 2 years.
3. History of lower limb injury 3 months prior to study.
4. Presence of problems that affect balance performance as visual or vestibular deficits, neurologic disease, or cerebral concussions during the past 3 months.
5. Being currently enrolled in a balance training rehabilitation program.
6. Weakness of lower limb musculatures or trunk upon screening muscle testing by the investigator.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy participants	Smartphone "MyAnkle" balance application	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.
Patients with CAI	Smartphone "MyAnkle" balance application	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.

Primary Outcome Measures

Name	Time	Method
Concurrent validity of smartphone MyAnkle application	One day	Correlation between the score of "MyAnkle" smartphone balance application and stability score of the Biodex balance system.

Secondary Outcome Measures

Name	Time	Method
Intrarater reliability of smartphone measurements	one week	same investigator will repeat balance assessment using "MyAnkle" smartphone balance application
Interrater reliability of smartphone measurements	one day	Three investigators will assess balance using the MyAnkle smartphone application

Trial Locations

Locations (1)

Faculty of Physical therapy, Cairo University; 🇪🇬 Giza, Egypt