Smartphone for Assessing Balance in Patients With Ankle Instability

NCT03598985 | Completed DMC

• 1 other identifier: NAbdo
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Ankle Instability

Keywords

Balance; Smartphone; Validity; Reliability; chronic ankle instability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Intrarater reliability of smartphone measurements

  one week

• Interrater reliability of smartphone measurements

  one day

Study Arms (2)

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

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

Interventions

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.

Also known as: Biodex Balance system

Healthy participants; Patients with CAI

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical therapy, Cairo University

Giza, 11391, Egypt

Location

Related Publications (21)

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Study Officials

• Aliaa Rehan Youssef, PhD

  Cairo University, Faculty of Physical Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: July 23, 2018
• Primary Completion: February 27, 2019
• Study Completion: May 30, 2019
• Last Updated: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

EG (1)