Palpation of the Ileotibial Band Tension
Condition: Healthy
Study type: Interventional

Summary: 
      The goal of this clinical-test study is to evaluate the reliability of the direct palpation
      of the ileotibial band. For this purpose, a group of 100 healthy subjects will be considered.
      The main question it aims to answer regards the reproducibility of the intra and inter
      examiner evaluation performed on the same day (intra-day) and the validation of the palpatory
      examination with an instrumental measure of the tissue tension.

      Participants will undergo a manual and instrumental sampling of the ileotibial band tension
      of both legs.
    

Detailed description: 
      The project includes 6 phases:

      I phase - agreement in principle on the method of collection; II phase - recruitment; III
      phase - first sampling; IV phase - training on perception and concordance; V phase - second
      sampling to verify the progression of the agreement; VI phase - third manual sampling and
      evaluation with Myoton.

      Description of the phases

      Phase I - Two examiners together with the principal investigator perform 2 hours of training
      to standardize the sampling method (localization of the point to be evaluated of the
      Iileotibial band -ITB- and intensity of pressure of the fingertips to be used) and discussion
      on the tension gradation detected on the ITB with some volunteers.

      Phase II - The recruitment will be carried out through the search for volunteers among the
      students of the OSCE-Bologna school of osteopathy, through announcement in the classroom and
      publication of the recruitment in the FB social group of the school (OSCE planet) and
      WhatsApp groups of students organized by year .

      Phase III - First sampling of manual evaluation only, using a sample of 40 subjects (both
      limbs), as proposed in the literature.

      The detection is to identify if there is an equal or different stiffness between the right
      and left ITB.

      The transcript of the discovery will be double for each sampling session: 1) the first will
      report whether there is a uniformity of the tension between the two sides, or if there is a
      prevalence on one side; the second will try to quantify, in case there is a difference
      between the two sides, with a graduation of 3 levels of the difference.

      In the first survey, the examiner will indicate a higher tension on the right side with +1; -
      1 on the left side; 0 if there are no significant differences.

      The second detection is to identify, when present, the graduation of the stiffness difference
      between the two sides, arbitrarily divided into 3 levels. The examiner, therefore, will
      report:

        -  3 to indicate greater tension on the right with a large difference from the left;

        -  2 to indicate a higher tension on the right with an average difference compared to the
           left;

        -  1 to indicate greater tension on the right with a slight difference from the left; 0 to
           indicate a non-appreciable prevalence of tension on one side over the other;

             -  3 to indicate greater tension on the left with a large difference compared to the
                right;

             -  2 to indicate a greater tension on the left with an average difference compared to
                the right;

             -  1 to indicate more tension on the left with a slight difference from the right.

      IV phase - The manual examiners carry out a training period on perception and concordance,
      lasting about 20 hours. This training is carried out using instruments (gold standard) made
      specifically to modify the state of stiffness of elastic structures and strings that simulate
      the ITB, connected to dynamometers to measure the amount of stiffness. In vivo evaluation,
      among the operators, are used to verify the exact positioning where to perform the stiffness
      sampling and compare the tension data obtained for the construction of the agreement.

      V phase - The second sampling to verify the progression of the manual agreement, as proposed
      in the literature, is carried out by evaluating the stiffness of the ITB, in the same way as
      for the first sampling with volunteers, but in a reduced sample (about 20 subjects). If the
      statistical processing of the results of this test evaluation shows a good level in the
      agreement (Cohen K > 0.60), the definitive sampling is scheduled at a later date; otherwise
      you return to training by increasing the hours.

      VI phase - The definitive manual sampling consists in repeating, using the same method of the
      first evaluation (baseline), with different or identical subjects of the first sampling. The
      number of subjects will always be 40, evaluated by both examiners and each examiner will
      evaluate the same subject twice at a distance of about 20-60 minutes. The same subjects will
      be tested, after the manual evaluation, with the Myoton using the modality previously
      described. The Myoton results are automatically stored in the preset instrument with the
      subject's ID and can be downloaded to the computer in an Excel worksheet.

      All the data obtained is collected and processed by the examiner who does not participate
      directly in the data collection using an Excel spreadsheet and / or the R program.
    

Intervention name(s): Manual evaluation of ITB tension
Intervention type(s): Other
Intervention description(s): There will be a double evaluation for each sampling session: 1) if there is a uniformity of the tension between the two sides, or if there is a prevalence on one side; 2) quantification of the difference, if present, with a graduation in 3 levels.
Intervention model: Single Group Assignment
Intervention model description: Three different group (40, 20 and 40 subjects respectively) are enrolled in sequence and undergo the same evaluation procedure.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ileotibial band; clinical-test; direct palpation