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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
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
Device: Traditional Learning Method
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Malaga

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACuesta07072013

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