NCT04138511

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2016

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

1.4 years

First QC Date

October 18, 2019

Last Update Submit

October 24, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    After the self-study periods in both study groups, up to two weeks.

Secondary Outcomes (1)

  • Multiple Choice Questionnaire (MCQ)

    After the self-study periods in both study groups, up to two weeks.

Other Outcomes (1)

  • Satisfaction survey

    After the self-study periods in both study groups, up to two weeks.

Study Arms (2)

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.

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

Interventions

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.

Experimental group (ECOFISIO)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • \- To have received any previous training in ultrasound imaging and managing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 24, 2019

Study Start

January 1, 2014

Primary Completion

June 1, 2015

Study Completion

December 21, 2016

Last Updated

October 28, 2019

Record last verified: 2019-10