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Smartphone for Assessing Balance in Patients With Ankle Instability

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ClinicalTrials.gov Identifier: NCT03598985
Recruitment Status : Completed
First Posted : July 25, 2018
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Aliaa Rehan Youssef, 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).

Condition or disease Intervention/treatment
Chronic Ankle Instability Diagnostic Test: Smartphone "MyAnkle" balance application

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?


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Study Type : Observational
Actual Enrollment : 67 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Validity and Reliability of a Smartphone Application for Assessing Balance in Patients With Chronic Ankle Instability
Actual Study Start Date : July 23, 2018
Actual Primary Completion Date : February 27, 2019
Actual Study Completion Date : May 30, 2019

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 Name: 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 Name: Biodex Balance system




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598985


Locations
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Egypt
Faculty of Physical therapy, Cairo University
Giza, Egypt, 11391
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Aliaa Rehan Youssef, PhD Cairo University, Faculty of Physical Therapy

Publications:

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Responsible Party: Aliaa Rehan Youssef, assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT03598985     History of Changes
Other Study ID Numbers: NAbdo
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6 months of study completion.
Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aliaa Rehan Youssef, Cairo University:
Balance
Smartphone
Validity
Reliability
chronic ankle instability
Additional relevant MeSH terms:
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Joint Instability
Joint Diseases
Musculoskeletal Diseases