Sport InjuryNCT04138511
Ecofisio, a Mobile Application for Assessment and Diagnosis Using Ultrasound Imaging for Undergraduate Health Science Students
A study testing ECOFISIO in people with Sport Injury and Educational Problems, run by Irene Cantarero Villanueva.
Trial summary
The new called "Generation Z" is starting to reach college age. They have adopted technology and create a deep dependence on it, becoming more drawn to the virtual world. M-learning has experienced a huge expansion in recent years in both, medical context and medical and health's sciences education. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sport Injury, Educational Problems
- What is being tested?
- ECOFISIO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to 21 Dec 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To have anatomy and biomechanics previous knowledge.
- To be enrolled in any required subject.
- To have basic ability to use a mobile application.
- To have a smartphone with Internet Access (Android Operating System).
Who cannot join
- To have received any previous training in ultrasound imaging and managing.
About this study
The new called "Generation Z" is starting to reach college age. They have adopted technology and create a deep dependence on it, becoming more drawn to the virtual world. M-learning has experienced a huge expansion in recent years in both, medical context and medical and health's sciences education. Ultrasound is an important diagnosis technique in physiotherapy, especially in sports pathology. m-Learning environments could be a useful tool for improve the comprehension of ultrasound concepts and the acquisition of professional competencies. The purpose of this study was to evaluate the efficacy and the use of an interactive platform accessible through mobile devices (ECOFISIO) using ultrasound imaging for the development of professional competencies in the evaluation and diagnosis of sports pathologies.
Participants were 110 undergraduate students enrolled in two groups of this randomized controlled multicentre study: a control group (traditional learning) and experimental group (ECOFISIO mobile application). All participants were assessed both theoretically and by means of the Objective Structured Clinical Examination (OSCE) exams.
- Conditions
- Sport Injury, Educational Problems
- Being tested
- ECOFISIO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECOFISIODevice
The ECOFISIO application is focused on sports pathologies and contains relevant written and digital information about ultrasound imaging and managing as well as diagnosis of sport injuries.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (ECOFISIO) | Experimental | Ecofisio Group received the ECOFISIO mobile application after students had received theoretical-practical lessons about ultrasound skills in sports pathologies areas, to study the subject. Receives: Device: ECOFISIO |
| Control Group | No intervention | Students received theoretical-practical lessons about ultrasound skills in sports pathologies areas and used traditional study models, to study the subject |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Structured Clinical Examination (OSCE)
An OSCE is a type of examination often used in health sciences. It is designed to test clinical skill performance and competence in a range of skills. The OSCE content and scoring procedures are standardized. It consists of five stations with five specific components of musculoskeletal ultrasound. Each test station is designed to focus on an area of clinical competence, namely: patient positioning, ultrasound probe positioning, ultrasound probe orientation (angle), ultrasound probe management and image adjustment. A standardized scoring tool is used to record what you do or don't do well, with a Likert scale with a range of 0 to 4 to rate the specific efficiency of each component. All OSCE candidates experience the same problem and are asked to perform the same task, within the same deadline. OSCEs are now widely used in undergraduate, graduate and undergraduate assessments. Overall reliability for this tool, Cronbach's alpha, is 0.89.
Measured: After the self-study periods in both study groups, up to two weeks.
Secondary outcomes (1)
Multiple Choice Questionnaire (MCQ)
The MCQ is an evaluation of the theoretical knowledge with 20 questions where a maximum score of 10 points could be obtained.The higher score, the better outcome.
Measured: After the self-study periods in both study groups, up to two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study startJan 2014
- Primary completionJun 2015
- Study completion21 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sport InjuryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irene Cantarero Villanueva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Irene Cantarero Villanueva, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138511
- Sponsor's protocol ID
- EcoFisio PID 14-56
- Status last verified
- Oct 2019
- First submitted
- 18 Oct 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lozano-Lozano M, Galiano-Castillo N, Fernandez-Lao C, Postigo-Martin P, Alvarez-Salvago F, Arroyo-Morales M, Cantarero-Villanueva I. The Ecofisio Mobile App for Assessment and Diagnosis Using Ultrasound Imaging for Undergraduate Health Science Students: Multicenter Randomized Controlled Trial. J Med Internet Res. 2020 Mar 10;22(3):e16258. doi: 10.2196/16258.
PubMed 32154784
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ecofisio, a Mobile Application for Assessment and Diagnosis Using Ultrasound Imaging for Undergraduate Health Science Students
- ClinicalTrials.gov ID
- NCT04138511
- Acronym / sponsor ID
- EcoFisio PID 14-56
- Conditions
- Sport Injury, Educational Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Irene Cantarero VillanuevaUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 24 Oct 2019 (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.
The new called "Generation Z" is starting to reach college age. They have adopted technology and create a deep dependence on it, becoming more drawn to the virtual world. M-learning has experienced a huge expansion in recent years in both, medical context and medical and health's sciences education. Ultrasound is an important diagnosis technique in physiotherapy, especially in sports pathology. m-Learning environments could be a useful tool for improve the comprehension of ultrasound concepts and the acquisition of professional competencies. The purpose of this study was to evaluate the efficacy and the use of an interactive platform accessible through mobile devices (ECOFISIO) using ultrasound imaging for the development of professional competencies in the evaluation and diagnosis of sports pathologies.
Participants were 110 undergraduate students enrolled in two groups of this randomized controlled multicentre study: a control group (traditional learning) and experimental group (ECOFISIO mobile application). All participants were assessed both theoretically and by means of the Objective Structured Clinical Examination (OSCE) exams.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (ECOFISIO) | Experimental | Device: ECOFISIOEcofisio Group received the ECOFISIO mobile application after students had received theoretical-practical lessons about ultrasound skills in sports pathologies areas, to study the subject. |
| Control Group | No intervention | –Students received theoretical-practical lessons about ultrasound skills in sports pathologies areas and used traditional study models, to study the subject |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- To have anatomy and biomechanics previous knowledge.
- To be enrolled in any required subject.
- To have basic ability to use a mobile application.
- To have a smartphone with Internet Access (Android Operating System).
Key exclusion criteria (1 listed)
- To have received any previous training in ultrasound imaging and managing.
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 |
|---|---|---|
| ECOFISIOThe ECOFISIO application is focused on sports pathologies and contains relevant written and digital information about ultrasound imaging and managing as well as diagnosis of sport injuries. | Device | Experimental group (ECOFISIO) |
Primary outcome
Objective Structured Clinical Examination (OSCE)
Time frame: After the self-study periods in both study groups, up to two weeks.
An OSCE is a type of examination often used in health sciences. It is designed to test clinical skill performance and competence in a range of skills. The OSCE content and scoring procedures are standardized. It consists of five stations with five specific components of musculoskeletal ultrasound. Each test station is designed to focus on an area of clinical competence, namely: patient positioning, ultrasound probe positioning, ultrasound probe orientation (angle), ultrasound probe management and image adjustment. A standardized scoring tool is used to record what you do or don't do well, with a Likert scale with a range of 0 to 4 to rate the specific efficiency of each component. All OSCE candidates experience the same problem and are asked to perform the same task, within the same deadline. OSCEs are now widely used in undergraduate, graduate and undergraduate assessments. Overall reliability for this tool, Cronbach's alpha, is 0.89.
1 secondary outcome
Multiple Choice Questionnaire (MCQ)
Time frame: After the self-study periods in both study groups, up to two weeks.
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 28 Oct 2019.
- Derived from this study: PubMed 32154784Lozano-Lozano M, Galiano-Castillo N, Fernandez-Lao C, Postigo-Martin P, Alvarez-Salvago F, Arroyo-Morales M, Cantarero-Villanueva I. The Ecofisio Mobile App for Assessment and Diagnosis Using Ultrasound Imaging for Undergraduate Health Science Students: Multicenter Randomized Controlled Trial. J Med Internet Res. 2020 Mar 10;22(3):e16258. doi: 10.2196/16258.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ECOFISIO in people with Sport Injury and Educational Problems, run by Irene Cantarero Villanueva.
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 4 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 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Objective Structured Clinical Examination (OSCE) (time frame: After the self-study periods in both study groups, up to two weeks.). 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 NCT04138511, which also lists 1 linked publication.
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 28 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.