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Completed

NCT Number: NCT03598985

Smartphone for Assessing Balance in Patients With Ankle Instability

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).

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Physical therapy, Cairo University

Giza, 11391, Egypt

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smartphone "MyAnkle" balance application

Diagnostic Test

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.

Other names: Biodex Balance system

Primary outcomes

  1. Concurrent validity of smartphone MyAnkle application

    Time frame: One day

    Correlation between the score of "MyAnkle" smartphone balance application and stability score of the Biodex balance system.

Secondary outcomes

  1. Intrarater reliability of smartphone measurements

    Time frame: one week

    same investigator will repeat balance assessment using "MyAnkle" smartphone balance application

  2. Interrater reliability of smartphone measurements

    Time frame: one day

    Three investigators will assess balance using the MyAnkle smartphone application

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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