Smartphone for Assessing Balance in Patients With Ankle Instability

Chronic Ankle Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03598985
• Other study ID #: NAbdo
• Status: Completed
• Start date: July 23, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: October 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 30, 2019
• Est. primary completion date: February 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Ankle Instability
• Joint Instability

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Physical therapy, Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (21)

Anandacoomarasamy A, Barnsley L. Long term outcomes of inversion ankle injuries. Br J Sports Med. 2005 Mar;39(3):e14; discussion e14. — View Citation

Bahr R, Karlsen R, Lian O, Ovrebø RV. Incidence and mechanisms of acute ankle inversion injuries in volleyball. A retrospective cohort study. Am J Sports Med. 1994 Sep-Oct;22(5):595-600. — View Citation

Capela NA, Lemaire ED, Baddour N, Rudolf M, Goljar N, Burger H. Evaluation of a smartphone human activity recognition application with able-bodied and stroke participants. J Neuroeng Rehabil. 2016 Jan 20;13:5. doi: 10.1186/s12984-016-0114-0. — View Citation

Chiu YL, Tsai YJ, Lin CH, Hou YR, Sung WH. Evaluation of a smartphone-based assessment system in subjects with chronic ankle instability. Comput Methods Programs Biomed. 2017 Feb;139:191-195. doi: 10.1016/j.cmpb.2016.11.005. Epub 2016 Nov 11. — View Citation

Delahunt E, Monaghan K, Caulfield B. Altered neuromuscular control and ankle joint kinematics during walking in subjects with functional instability of the ankle joint. Am J Sports Med. 2006 Dec;34(12):1970-6. Epub 2006 Aug 22. — View Citation

Delahunt E, Monaghan K, Caulfield B. Changes in lower limb kinematics, kinetics, and muscle activity in subjects with functional instability of the ankle joint during a single leg drop jump. J Orthop Res. 2006 Oct;24(10):1991-2000. — View Citation

Doherty C, Delahunt E, Caulfield B, Hertel J, Ryan J, Bleakley C. The incidence and prevalence of ankle sprain injury: a systematic review and meta-analysis of prospective epidemiological studies. Sports Med. 2014 Jan;44(1):123-40. doi: 10.1007/s40279-013-0102-5. Review. — View Citation

Freeman MA, Dean MR, Hanham IW. The etiology and prevention of functional instability of the foot. J Bone Joint Surg Br. 1965 Nov;47(4):678-85. — View Citation

Garrick JG. The frequency of injury, mechanism of injury, and epidemiology of ankle sprains. Am J Sports Med. 1977 Nov-Dec;5(6):241-2. — View Citation

Hertel J. Functional Anatomy, Pathomechanics, and Pathophysiology of Lateral Ankle Instability. J Athl Train. 2002 Dec;37(4):364-375. — View Citation

Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41. — View Citation

Mourcou Q, Fleury A, Diot B, Vuillerme N. iProprio: a smartphone-based system to measure and improve proprioceptive function. Conf Proc IEEE Eng Med Biol Soc. 2016 Aug;2016:2622-2625. doi: 10.1109/EMBC.2016.7591268. — View Citation

Patterson JA, Amick RZ, Thummar T, Rogers ME. Validation of measures from the smartphone sway balance application: a pilot study. Int J Sports Phys Ther. 2014 Apr;9(2):135-9. — View Citation

Perron M, Hébert LJ, McFadyen BJ, Belzile S, Regniére M. The ability of the Biodex Stability System to distinguish level of function in subjects with a second-degree ankle sprain. Clin Rehabil. 2007 Jan;21(1):73-81. — View Citation

Roeing KL, Hsieh KL, Sosnoff JJ. A systematic review of balance and fall risk assessments with mobile phone technology. Arch Gerontol Geriatr. 2017 Nov;73:222-226. doi: 10.1016/j.archger.2017.08.002. Epub 2017 Aug 4. Review. — View Citation

Ross SE, Guskiewicz KM, Gross MT, Yu B. Balance measures for discriminating between functionally unstable and stable ankles. Med Sci Sports Exerc. 2009 Feb;41(2):399-407. doi: 10.1249/MSS.0b013e3181872d89. — View Citation

Ross SE, Guskiewicz KM. Examination of static and dynamic postural stability in individuals with functionally stable and unstable ankles. Clin J Sport Med. 2004 Nov;14(6):332-8. — View Citation

Schwenk M, Mohler J, Wendel C, D'Huyvetter K, Fain M, Taylor-Piliae R, Najafi B. Wearable sensor-based in-home assessment of gait, balance, and physical activity for discrimination of frailty status: baseline results of the Arizona frailty cohort study. Gerontology. 2015;61(3):258-67. doi: 10.1159/000369095. Epub 2014 Dec 24. — View Citation

Shah N, Aleong R, So I. Novel Use of a Smartphone to Measure Standing Balance. JMIR Rehabil Assist Technol. 2016 Mar 29;3(1):e4. doi: 10.2196/rehab.4511. — View Citation

Testerman C, Vander Griend R. Evaluation of ankle instability using the Biodex Stability System. Foot Ankle Int. 1999 May;20(5):317-21. — View Citation

Triantafyllidis AK, Velardo C, Salvi D, Shah SA, Koutkias VG, Tarassenko L. A Survey of Mobile Phone Sensing, Self-Reporting, and Social Sharing for Pervasive Healthcare. IEEE J Biomed Health Inform. 2017 Jan;21(1):218-227. doi: 10.1109/JBHI.2015.2483902. Epub 2015 Sep 29. Review. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intrarater reliability of smartphone measurements	same investigator will repeat balance assessment using "MyAnkle" smartphone balance application	one week
Secondary	Interrater reliability of smartphone measurements	Three investigators will assess balance using the MyAnkle smartphone application	one day