NCT01911338

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
Last Updated

December 4, 2014

Status Verified

July 1, 2013

Enrollment Period

4 months

First QC Date

July 23, 2013

Last Update Submit

December 3, 2014

Conditions

Keywords

Spinal ManipulationTeachingThoracic VertebraeFeedback

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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

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

Device: Traditional Learning Method

Interventions

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

Real Time Feedback

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

Tradicional Learning Method

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.

You may not qualify if:

  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Manuel González-Sánchez, PT, PhD

    University of Malaga

    PRINCIPAL INVESTIGATOR
  • Yves Lenfant, PT

    University of Malaga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 23, 2013

First Posted

July 30, 2013

Study Start

February 1, 2012

Primary Completion

June 1, 2012

Study Completion

September 1, 2012

Last Updated

December 4, 2014

Record last verified: 2013-07