Chronic Ankle InstabilityNCT03598985
Smartphone for Assessing Balance in Patients With Ankle Instability
An observational study of Chronic Ankle Instability, run by Cairo University at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- Smartphone "MyAnkle" balance application
- How many people
- 67 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jul 2018to 30 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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?
- Conditions
- Chronic Ankle Instability
- Being tested
- Smartphone "MyAnkle" balance application
- Keywords
- Balance, Smartphone, Validity, Reliability, chronic ankle instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone "MyAnkle" balance applicationDiagnostic test
Also called Biodex Balance system
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Smartphone "MyAnkle" balance application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concurrent validity of smartphone MyAnkle application
Correlation between the score of "MyAnkle" smartphone balance application and stability score of the Biodex balance system.
Measured: One day
Secondary outcomes (2)
Intrarater reliability of smartphone measurements
same investigator will repeat balance assessment using "MyAnkle" smartphone balance application
Measured: one week
Interrater reliability of smartphone measurements
Three investigators will assess balance using the MyAnkle smartphone application
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start23 Jul 2018
- Primary completion27 Feb 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Rehan Youssef, Cairo University
- Investigators
- Aliaa Rehan Youssef, PhD, Principal investigator, Cairo University, Faculty of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598985
- Sponsor's protocol ID
- NAbdo
- Status last verified
- Oct 2019
- First submitted
- 16 Jul 2018
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data for all primary and secondary outcome measures will be made available.
Publications
Anandacoomarasamy A, Barnsley L. Long term outcomes of inversion ankle injuries. Br J Sports Med. 2005 Mar;39(3):e14; discussion e14. doi: 10.1136/bjsm.2004.011676.
PubMed 15728682Bahr R, Karlsen R, Lian O, Ovrebo 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. doi: 10.1177/036354659402200505.
PubMed 7810781Capela 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.
PubMed 26792670Chiu 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.
PubMed 28187890Delahunt 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. doi: 10.1002/jor.20235.
PubMed 16894592Delahunt 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. doi: 10.1177/0363546506290989. Epub 2006 Aug 22.
PubMed 16926342Doherty 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.
PubMed 24105612Hiller 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. doi: 10.1016/j.apmr.2006.05.022.
PubMed 16935061Freeman 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. No abstract available.
PubMed 5846767Garrick JG. The frequency of injury, mechanism of injury, and epidemiology of ankle sprains. Am J Sports Med. 1977 Nov-Dec;5(6):241-2. doi: 10.1177/036354657700500606. No abstract available.
PubMed 563179Patterson 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.
PubMed 24790774Triantafyllidis 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.
PubMed 26441432Mourcou Q, Fleury A, Diot B, Vuillerme N. iProprio: a smartphone-based system to measure and improve proprioceptive function. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:2622-2625. doi: 10.1109/EMBC.2016.7591268.
PubMed 28268860Perron M, Hebert LJ, McFadyen BJ, Belzile S, Regniere 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. doi: 10.1177/0269215506071288.
PubMed 17213244Roeing 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.
PubMed 28843965
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of a Smartphone Application for Assessing Balance in Patients With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT03598985
- Acronym / sponsor ID
- NAbdo
- Conditions
- Chronic Ankle Instability
- Keywords
- Balance, Smartphone, Validity, Reliability, chronic ankle instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with CAI | – | Diagnostic Test: Smartphone "MyAnkle" balance applicationPatients 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. |
| Healthy participants | – | Diagnostic Test: Smartphone "MyAnkle" balance applicationHealthy 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone "MyAnkle" balance applicationAlso: Biodex Balance systemBalance 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. | Diagnostic test | Healthy participants, Patients with CAI |
Primary outcome
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.
2 secondary outcomes
Intrarater reliability of smartphone measurements
Time frame: one week
Interrater reliability of smartphone measurements
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Background: PubMed 15728682Anandacoomarasamy A, Barnsley L. Long term outcomes of inversion ankle injuries. Br J Sports Med. 2005 Mar;39(3):e14; discussion e14. doi: 10.1136/bjsm.2004.011676.
- Background: PubMed 7810781Bahr R, Karlsen R, Lian O, Ovrebo 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. doi: 10.1177/036354659402200505.
- Background: PubMed 26792670Capela 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.
- Background: PubMed 28187890Chiu 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.
- Background: PubMed 16894592Delahunt 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. doi: 10.1002/jor.20235.
- Background: PubMed 16926342Delahunt 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. doi: 10.1177/0363546506290989. Epub 2006 Aug 22.
- Background: PubMed 24105612Doherty 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.
- Background: PubMed 16935061Hiller 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. doi: 10.1016/j.apmr.2006.05.022.
- Background: PubMed 5846767Freeman 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. No abstract available.
- Background: PubMed 563179Garrick JG. The frequency of injury, mechanism of injury, and epidemiology of ankle sprains. Am J Sports Med. 1977 Nov-Dec;5(6):241-2. doi: 10.1177/036354657700500606. No abstract available.
- Background: PubMed 24790774Patterson 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.
- Background: PubMed 26441432Triantafyllidis 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.
- Individual participant dataSharing planned: Yes. Individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliaa Rehan Youssef, PhD principal investigator
Cairo University, Faculty of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Ankle Instability, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concurrent validity of smartphone MyAnkle application (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03598985, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.