Smartphone for Assessing Balance in Patients With Ankle Instability

October 22, 2019 updated by: Aliaa Rehan Youssef, Cairo University

Validity and Reliability of a Smartphone Application for Assessing Balance in Patients With Chronic 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 11391
        • Faculty of physical therapy, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Fifty patients with CAI and 50 gender-, BMI and age-matched healthy volunteers will be enrolled in this study.

Healthy participants will be recruited from undergraduate and graduate students of the faculty of Physical Therapy, Cairo University, Egypt. All healthy subjects will be asymptomatic with no neuromusculoskeletal signs or symptoms.

Male and female adult patients with CAI will be recruited from the outpatient clinic of the faculties of Physical Therapy and Medicine, Cairo University, Egypt.

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with CAI

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
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
Healthy participants

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 23, 2018

Primary Completion (ACTUAL)

February 27, 2019

Study Completion (ACTUAL)

May 30, 2019

Study Registration Dates

First Submitted

July 16, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (ACTUAL)

July 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 22, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAbdo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 6 months of study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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