- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02975531
Simulator of Pompage Technique for Physiotherapists
November 28, 2016 updated by: Annie France Frère Slaets, University of Mogi das Cruzes
Simulator of Pompage Technique for Education and Training of Physiotherapists
Parameterize the Pompage technique with an anatomical model cervical region to simulate specific procedures.
Quantify the times, displacements, and facilitate the training of students and professional of physical therapy.
Study Overview
Status
Completed
Conditions
Detailed Description
Manual techniques are taught and trained with practical demonstration without technology support to measure them, so they are difficult to reproduce.
This difficulty increases in Pompage technique because the student is not able to estimate the displacement on the skin.
In this research, to parameterize and train the technique was developed and validated an anatomical model of the cervical region, with silicone and latex rubber.
The anatomical model simulates the soft tissues and a plastic resin structure represents the cervical spine bone.
An optical sensor was used to measure the displacements performed on simulated skin versus time.
The Likert scale was used for assessing the similarity of the anatomical model relative to the size, shape, texture, elasticity and displacement of the skin as well as the curvature of the cervical spine.
Five experienced professionals (GP) in the technical performed five series of Pompage technique.
With the mean of data collected were determined benchmarks for technical and implemented in a standard guide to train the volunteers.
Twenty-six volunteers (GE) with no experience performed the Pompage technique, with the anatomical model following the standard guide.
A physical therapist (VE) was selected to evaluate the volunteers (GE) before and after training in the simulator.
Study Type
Interventional
Enrollment (Actual)
72
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 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- no history of cervical trauma (GT and VF)
- Do not have dermatitis in the cervical region (GT and VF)
- recurrent migraines (GT and VF)
- no prior knowledge of Pompage technique (GE).
- minimum 5 years experience of applying the Pompage technique (GP and VE).
Exclusion Criteria:
- report pain in the cervical region (GT and VF)
- irritations in the cervical region (GT and VF)
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: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Simulator's construction
To build the simulator was selected a volunteer (VF) as a model.
This volunteer had no complaints of pain or trauma to the cervical region.
This region was used to collect the displacement of the skin and cytometry neck.
|
Model to build the mold for the simulator
Other Names:
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EXPERIMENTAL: Model Features
Thirty-nine volunteers (GT) were selected men and women aged over 18 years without history of trauma in the cervical region in order to determine the characteristics of the model: skin elasticity and cirtometry neck.
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Volunteers to determine the elasticity of the skin and cirtometry neck to compare with the simulator.
Other Names:
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EXPERIMENTAL: Parameterization technique
Five physiotherapists (GP) with at least 5 years of experience in the technique were selected to perform the technique on the simulator and complete a questionnaire in order to evaluate the texture and skin elasticity, the curvature and size of the cervical spine format.
They scored these items from the Likert scale.
After evaluation they used the simulator to generate a standard guide training.
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Evaluation of the simulator features and parameterization of the Pompage technique in the simulator.
Other Names:
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EXPERIMENTAL: Simulator training
Twenty-six volunteers (GE) were selected, men and women, aged over 18 years without prior knowledge of the technique for simulator training.
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Training of pompage technique using the simulator.
Other Names:
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EXPERIMENTAL: Training Evaluation
A physical therapist (VE) was selected to evaluate the volunteers (GE) before and after training in the simulator.
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Evaluation of volunteers from GE group before and after training with the simulator.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Displacement of the skin
Time Frame: 5 days
|
The displacement of the skin (mm) of the volunteers VF and GT was measured to validated the simulator.
The volunteers GE used the simulator and the displacement of the skin of simulator was measured during the Pompage technique.
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5 days
|
|
Pressure
Time Frame: 5 days
|
The volunteers GE used the simulator and the pressure (mm/Hg ) on the simulator was measured during the Pompage technique.
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cytometry neck
Time Frame: 1 minute
|
The cytometry neck (cm) of the volunteers VF and GT was measure to validated the simulator.
|
1 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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, 2008
Primary Completion (ACTUAL)
April 1, 2008
Study Completion (ACTUAL)
February 1, 2012
Study Registration Dates
First Submitted
March 9, 2016
First Submitted That Met QC Criteria
November 28, 2016
First Posted (ESTIMATE)
November 29, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
November 29, 2016
Last Update Submitted That Met QC Criteria
November 28, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0121.0.237.00007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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