- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01911338
Inertial Sensors Used to Learn Manipulation
December 3, 2014 updated by: Dr. Antonio I Cuesta-Vargas, University of Malaga
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Exclusion Criteria:
- Refusal to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Real Time Feedback
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
|
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
|
|
Active Comparator: Tradicional Learning Method
Two expert teachers in manual therapy provided indications and corrections to the group with a teacher - student ratio of 1:8
|
Two expert teachers in manual therapy provided indications and corrections to the group with a teacher - student ratio of 1:8.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline; post-education; 24 weeks follow up
|
|
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.
|
baseline; post-education; 24 weeks follow up
|
|
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.
|
baseline; post-education; 24 weeks follow up
|
|
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.
|
baseline; post-education; 24 weeks follow up
|
|
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.
|
baseline; post-education; 24 weeks follow up
|
|
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.
|
baseline; post-education; 24 weeks follow up
|
|
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.
|
baseline; post-education; 24 weeks follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Manuel González-Sánchez, PT, PhD, University of Malaga
- Principal Investigator: Yves Lenfant, PT, University of Malaga
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
July 23, 2013
First Submitted That Met QC Criteria
July 29, 2013
First Posted (Estimate)
July 30, 2013
Study Record Updates
Last Update Posted (Estimate)
December 4, 2014
Last Update Submitted That Met QC Criteria
December 3, 2014
Last Verified
July 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- ACuesta07072013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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