Other Instability, Ankle and FootNCT02931916
Evaluation of Reliability and Validity of a Smart-phone Postural Control Assessment Application
An observational study of Other Instability, Ankle and Foot, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the reliability and validity of smart-phone based system in postural control ability assessment on subjects with chronic ankle instability. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Other Instability, Ankle and Foot
- How many people
- 138 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2016to 31 Aug 2018
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: chronic ankle instability group
Who may be able to join
- clinical diagnosis of ankle functional instability
Who cannot join
- any other condition would affect postural control performance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Reliability and Validity of a Smart-phone Application Designed for Chronic Ankle Instability Subjects' Postural Control Assessment
The purpose of this study is to evaluate the reliability and validity of smart-phone based system in postural control ability assessment on subjects with chronic ankle instability.
- Conditions
- Other Instability, Ankle and Foot
- Keywords
- smart-phone, assessment, chronic ankle instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy group | recruited for evaluation of system reliability | |
| Chronic Ankle Instability group | recruited for evaluation of system validity |
What is being measured
The primary outcome is the main question the study is designed to answer.
physiological parameter: acceleration data from built-in sensor with unit: m/s^2
Using the built-in sensor to record the acceleration data during each seconds trial.
Both x, y and z axialis will be recorded
Measured: 40 seconds
physiological parameter: orientation data from built-in sensor with unit: degree
Using the built-in sensor to record the acceleration data during each seconds trials.
Both x, y and z axialis will be recorded
Measured: 40 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startNov 2016
- Primary completion30 Mar 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Instability, Ankle and FootStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung 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
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Wen-Hsu Sung, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931916
- Sponsor's protocol ID
- 2016CAIAppR&V
- Status last verified
- Oct 2018
- First submitted
- 29 Sep 2016
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Reliability and Validity of a Smart-phone Application Designed for Chronic Ankle Instability Subjects' Postural Control Assessment
- ClinicalTrials.gov ID
- NCT02931916
- Acronym / sponsor ID
- 2016CAIAppR&V
- Conditions
- Other Instability, Ankle and Foot
- Keywords
- smart-phone, assessment, chronic ankle instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- Nov 2016
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 13 Oct 2016 (estimated)
- 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.
The purpose of this study is to evaluate the reliability and validity of smart-phone based system in postural control ability assessment on subjects with chronic ankle instability.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy group | – | –recruited for evaluation of system reliability |
| Chronic Ankle Instability group | – | –recruited for evaluation of system validity |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- chronic ankle instability group
Key inclusion criteria (1 listed)
- clinical diagnosis of ankle functional instability
Key exclusion criteria (1 listed)
- any other condition would affect postural control performance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
physiological parameter: acceleration data from built-in sensor with unit: m/s^2
Time frame: 40 seconds
Using the built-in sensor to record the acceleration data during each seconds trial. Both x, y and z axialis will be recorded
physiological parameter: orientation data from built-in sensor with unit: degree
Time frame: 40 seconds
Using the built-in sensor to record the acceleration data during each seconds trials. Both x, y and z axialis will be recorded
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 25 Oct 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Other Instability, Ankle and Foot, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 1 inclusion and 1 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 25 Oct 2018. 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 Taiwan. 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?
physiological parameter: acceleration data from built-in sensor with unit: m/s^2 (time frame: 40 seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2018.