Medical EducationNCT01911338
Inertial Sensors Used to Learn Manipulation
A study testing Real Time Feedback and Traditional Learning Method in people with Medical Education, run by University of Malaga.
Trial summary
Background Context: no studies have been identified to analyse the effect of real time feedback (using inertial sensors) on physiotherapy students learning the art of posterior-anterior thoracic manipulation (PATM). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Medical Education
- What is being tested?
- Real Time Feedback and Traditional Learning Method
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Sep 2012
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Who cannot join
- Refusal to participate in the study
About this study
Official title: EFFECT OF REAL-TIME FEEDBACK THROUGH INERTIAL SENSORS IN LEARNING POSTEROANTERIOR THORACIC MANIPULATION
- Background Context: no studies have been identified to analyse the effect of real time feedback (using inertial sensors) on physiotherapy students learning the art of posterior-anterior thoracic manipulation (PATM).
- Purpose: to study the effect caused by real-time feedback on the learning process for PATM, comparing two undergraduate physiotherapy student groups. Hypothesis: significant differences will exist in the execution parameters of manipulation among students receiving real-time feedback versus those who do not.
- Study Design/Setting: longitudinal, pre-post intervention.
- Patient Sample: Sixty-one undergraduate physiotherapy students were divided randomly into two groups, G1 (n = 31) (group without feedback in real time) and G2 (n = 30) (group with real-time feedback).
- Outcome Measures: time, displacement and velocity and improvement (only between groups) to reach maximum peak, to reach minimum peak from maximum peak, total manipulation time.
- Methods: two groups of physiotherapy students learned PATM, one using a traditional method and the other using real-time feedback (inertial sensor). Measures were obtained pre- and post-intervention. Intragroup pre- and post-intervention and intergroup post-intervention scores were calculated. An analysis of the measures' stability was developed through an ICC (1,2).
- Results: the values of ICC ranged from 0.881 to 0.997. Statistically significant differences were found in all variables analysed (intra- and inter-group) in favour of G2.
- Conclusions: the learning process for posterior-anterior thoracic manipulation is facilitated when the student receives real-time feedback.
- Conditions
- Medical Education
- Being tested
- Real Time Feedback, Traditional Learning Method
- Keywords
- Spinal Manipulation, Teaching, Thoracic Vertebrae, Feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Time FeedbackDevice
Before beginning practice, one of the teachers performed the manipulation and explained the graph parameters as real-time feedback to consider when interpreting the graph, leaving the graphic as the benchmark execution
Traditional Learning MethodDevice
Two expert teachers in manual therapy provided indications and corrections to the group with a teacher - student ratio of 1:8.
| Study group | Role | What they receive |
|---|---|---|
| Real Time Feedback | Experimental | Before beginning practice, one of the teachers performed the manipulation and explained the graph parameters as real-time feedback to consider when interpreting the graph, leaving the graphic as the benchmark execution Receives: Device: Real Time Feedback |
| Tradicional Learning Method | Active comparator | Two expert teachers in manual therapy provided indications and corrections to the group with a teacher - student ratio of 1:8 Receives: Device: Traditional Learning Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from displacement maximum peak (seconds)
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM. The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor. The manikin has a ribcage with a deformation capacity similar to that of a human thorax. This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students. The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Measured: baseline; post-education; 24 weeks follow up
Change from Time to reach maximum peak (seconds)
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM. The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor. The manikin has a ribcage with a deformation capacity similar to that of a human thorax. This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students. The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Measured: baseline; post-education; 24 weeks follow up
Change from Displacement between maximum and minimum peak (milimitres)
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM. The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor. The manikin has a ribcage with a deformation capacity similar to that of a human thorax. This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students. The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Measured: baseline; post-education; 24 weeks follow up
Change from Total manipulation time (seconds)
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM. The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor. The manikin has a ribcage with a deformation capacity similar to that of a human thorax. This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students. The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Measured: baseline; post-education; 24 weeks follow up
Change from Velocity to reach maximum peak (degrees per second)
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM. The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor. The manikin has a ribcage with a deformation capacity similar to that of a human thorax. This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students. The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Measured: baseline; post-education; 24 weeks follow up
Change from Time to reach peak minimum from maximum peak (seconds)
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM. The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor. The manikin has a ribcage with a deformation capacity similar to that of a human thorax. This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students. The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Measured: baseline; post-education; 24 weeks follow up
Change from Velocity to reach minimum peak from maximum peak (degress/second)
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM. The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor. The manikin has a ribcage with a deformation capacity similar to that of a human thorax. This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students. The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Measured: baseline; post-education; 24 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startFeb 2012
- Primary completionJun 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EducationStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
- Investigators
- Manuel González-Sánchez, PT, PhD, Principal investigator, University of MalagaYves Lenfant, PT, Principal investigator, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911338
- Sponsor's protocol ID
- ACuesta07072013
- Status last verified
- Jul 2013
- First submitted
- 23 Jul 2013
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF REAL-TIME FEEDBACK THROUGH INERTIAL SENSORS IN LEARNING POSTEROANTERIOR THORACIC MANIPULATION
- ClinicalTrials.gov ID
- NCT01911338
- Acronym / sponsor ID
- ACuesta07072013
- Conditions
- Medical Education
- Keywords
- Spinal Manipulation, Teaching, Thoracic Vertebrae, Feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Jul 2013 (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.
- Background Context: no studies have been identified to analyse the effect of real time feedback (using inertial sensors) on physiotherapy students learning the art of posterior-anterior thoracic manipulation (PATM).
- Purpose: to study the effect caused by real-time feedback on the learning process for PATM, comparing two undergraduate physiotherapy student groups. Hypothesis: significant differences will exist in the execution parameters of manipulation among students receiving real-time feedback versus those who do not.
- Study Design/Setting: longitudinal, pre-post intervention.
- Patient Sample: Sixty-one undergraduate physiotherapy students were divided randomly into two groups, G1 (n = 31) (group without feedback in real time) and G2 (n = 30) (group with real-time feedback).
- Outcome Measures: time, displacement and velocity and improvement (only between groups) to reach maximum peak, to reach minimum peak from maximum peak, total manipulation time.
- Methods: two groups of physiotherapy students learned PATM, one using a traditional method and the other using real-time feedback (inertial sensor). Measures were obtained pre- and post-intervention. Intragroup pre- and post-intervention and intergroup post-intervention scores were calculated. An analysis of the measures' stability was developed through an ICC (1,2).
- Results: the values of ICC ranged from 0.881 to 0.997. Statistically significant differences were found in all variables analysed (intra- and inter-group) in favour of G2.
- Conclusions: the learning process for posterior-anterior thoracic manipulation is facilitated when the student receives real-time feedback.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real Time Feedback | Experimental | Device: Real Time FeedbackBefore beginning practice, one of the teachers performed the manipulation and explained the graph parameters as real-time feedback to consider when interpreting the graph, leaving the graphic as the benchmark execution |
| Tradicional Learning Method | Active comparator | Device: Traditional Learning MethodTwo expert teachers in manual therapy provided indications and corrections to the group with a teacher - student ratio of 1:8 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Key exclusion criteria (1 listed)
- Refusal to participate in the study
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 |
|---|---|---|
| Real Time FeedbackBefore beginning practice, one of the teachers performed the manipulation and explained the graph parameters as real-time feedback to consider when interpreting the graph, leaving the graphic as the benchmark execution | Device | Real Time Feedback |
| Traditional Learning MethodTwo expert teachers in manual therapy provided indications and corrections to the group with a teacher - student ratio of 1:8. | Device | Tradicional Learning Method |
Primary outcome
Change from displacement maximum peak (seconds)
Time frame: baseline; post-education; 24 weeks follow up
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM. The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor. The manikin has a ribcage with a deformation capacity similar to that of a human thorax. This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students. The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Change from Time to reach maximum peak (seconds)
Time frame: baseline; post-education; 24 weeks follow up
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM. The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor. The manikin has a ribcage with a deformation capacity similar to that of a human thorax. This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students. The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Change from Displacement between maximum and minimum peak (milimitres)
Time frame: baseline; post-education; 24 weeks follow up
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM. The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor. The manikin has a ribcage with a deformation capacity similar to that of a human thorax. This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students. The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Change from Total manipulation time (seconds)
Time frame: baseline; post-education; 24 weeks follow up
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM. The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor. The manikin has a ribcage with a deformation capacity similar to that of a human thorax. This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students. The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Change from Velocity to reach maximum peak (degrees per second)
Time frame: baseline; post-education; 24 weeks follow up
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM. The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor. The manikin has a ribcage with a deformation capacity similar to that of a human thorax. This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students. The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Change from Time to reach peak minimum from maximum peak (seconds)
Time frame: baseline; post-education; 24 weeks follow up
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM. The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor. The manikin has a ribcage with a deformation capacity similar to that of a human thorax. This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students. The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Change from Velocity to reach minimum peak from maximum peak (degress/second)
Time frame: baseline; post-education; 24 weeks follow up
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM. The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor. The manikin has a ribcage with a deformation capacity similar to that of a human thorax. This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students. The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
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 4 Dec 2014.
Related trials for Medical Education
Not yet recruitingObservational study
Federated Learning in Renal Tumor Model
Renal Tumors
Not yet recruiting
Generative AI-Assisted Personalized Feedback for Laparoscopic Skill Learning in Medical Undergraduates
Medical Education
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
RecruitingObservational study
Artificial Intelligence for Automated Clinical Data Exploration From Electronic Medical Records (CardioMining-AI)
Artificial Intelligence, Machine Learning
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
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.
Manuel González-Sánchez, PT, PhD principal investigator
University of Malaga
Yves Lenfant, PT principal investigator
University of Malaga
Questions about this trial
What is this clinical trial studying?
A study testing Real Time Feedback and Traditional Learning Method in people with Medical Education, run by University of Malaga.
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 4 Dec 2014. 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?
Change from displacement maximum peak (seconds) (time frame: baseline; post-education; 24 weeks follow up). The study lists 7 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 4 Dec 2014.