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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01911338
Other study ID # ACuesta07072013
Secondary ID
Status Completed
Phase N/A
First received July 23, 2013
Last updated December 3, 2014
Start date February 2012
Est. completion date September 2012

Study information

Verified date July 2013
Source University of Malaga
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical 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).

- 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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date September 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Device:
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
Traditional Learning Method
Two expert teachers in manual therapy provided indications and corrections to the group with a teacher - student ratio of 1:8.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Malaga

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline; post-education; 24 weeks follow up Yes
Primary 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. baseline; post-education; 24 weeks follow up Yes
Primary 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. baseline; post-education; 24 weeks follow up Yes
Primary 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. baseline; post-education; 24 weeks follow up Yes
Primary 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. baseline; post-education; 24 weeks follow up Yes
Primary 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. baseline; post-education; 24 weeks follow up Yes
Primary 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. baseline; post-education; 24 weeks follow up Yes
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