Reliability and Validity of Goniometric iPhone Applications
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Observational

Summary: 
      The purpose of this study is to determine the test-retest and inter-rater reliability and
      concurrent validity of two iPhone goniometric applications in the measurement of active
      shoulder external rotation as compared to a standard manual goniometer. The scientific
      hypotheses for this study are as follows:

        1. There will be significant Pearson correlations (>.8) to demonstrate test-retest
           reliability for each of the tools between the 1st and 2nd round of testing as assessed
           by novice testers.

        2. There will be significant intra-class correlation coefficients (>.8) to demonstrate
           inter-rater reliability between the novice tester and the experienced tester for each of
           the three tools.

        3. There will be significant Pearson correlations (>.8) to demonstrate concurrent validity
           between the standard goniometer and the photo capture application, the standard
           goniometer and the accelerometer-based application and the photo capture application
           with the accelerometer-based app. as assessed by novice testers.
    

Detailed description: 
      The purpose of this study is to determine the test-retest and inter-rater reliability and
      concurrent validity of two iPhone goniometric applications in the measurement of active
      shoulder external rotation as compared to a standard manual goniometer. This research is
      being done to determine if there are other more reliable, valid or innovative technological
      ways to measure active range of motion. Four testers (three entry-level doctoral students in
      physical therapy and one of two experienced physical therapists) will be measuring currently
      enrolled physical therapy doctoral students. The two experienced physical therapists are the
      principle investigator and the listed investigator who is a Physical Therapist. Two separate
      iPhone applications (DrGoniometer, which is based on photo capture and GetMyROM, which is
      based on the iPhone's internal accelerometer) and a standard manual goniometer will be used
      to measure the participants.

      All potential participants will receive a cover letter describing the study via email. If the
      student is interested in participating they will report to the testing room (wearing a tank
      top (male or female) or asked to remove their top (male)) at one of the scheduled testing
      times. All testing will occur in a laboratory room on the TWU-Houston campus. The participant
      will be asked to review and sign an informed consent form. Any questions related to the study
      will be specifically asked at this time but may be asked at any time during the duration of
      the study. The primary investigator or any co-investigator will assign a confidential
      participant number to the participant at this time. Next the participant will be asked to
      complete a demographic form. If the participant answers "yes" to question 4, 5, 6 or 7,
      he/she will be eliminated from the study and asked not to participate. At this time, the
      participant will be randomly assigned to testing table 1, 2 or 3 (all three tables will
      follow the same basic procedure but the participant will be assessed by the table's assigned
      instrument first). Also, the side of testing (left or right) will be randomly selected. For
      example, a participant may be randomly assigned to table 1 (right shoulder). The participant
      will report to table 1, which is the iPhone DrGoniometer station...therefore they will be
      measured with this tool first. All of the testers (novice and expert) will be blinded to the
      outcomes of the other measures. Tester 1 (novice) will evaluate active right shoulder
      external rotation range of motion (ROM) with the iPhone DrGoniometer with a piece of tape
      covering the measurement reading. Tester 1 will then hand the iPhone to the blinded recorder,
      who will remove the tape, record the measurement, replace the tape and hand the iPhone back
      to Tester 1. Then the participant will be measured with GetMyROM (by novice 2) and then the
      standard goniometer (by novice 3) in random order. Tape will also be placed over the
      measurements on the iPhone for GetMyROM and the standard goniometer in the same manner that
      will be used with DrGoniometer. Next, the skilled tester will measure the participant with
      the instrument used at the assigned table. The participant will stay with this assigned table
      for the duration of the testing. Now the participant will be asked to stand up and move
      around before returning to the table for the 2nd round of testing. At least fifteen minutes
      from initial testing, the three initial novice testers will repeat their measurements in the
      previous order. All measurements and time of testing for the first measurement will be
      recorded by blinded investigators (recorders) and entered into a password protected computer
      and password protected Excel file which will only be known to the primary investigator. The
      file and computer will be locked in the primary investigator's office when data collection is
      not actively taking place. The data linking the participant number with the participant's
      name will only be known by the primary investigator and the recording investigators. The
      iPhones will not be linked to the internet during the testing and all images will be deleted
      after the data is recorded. The data will be recorded on to an Excel data printout. After
      each data collection session, the data will be entered into the file electronically.

      Measurement of Shoulder External Rotation:

      This study will follow a standard measurement testing procedure for assessing shoulder
      external rotation. The participant will be asked to wear either a tank-top (females or males)
      or no shirt (males). The participant will lie on their back on a padded plinth (table). The
      participant will asked to place their test shoulder in approximately 90 degrees of abduction
      (away from the body) and the elbow flexed (bent) to 90 degrees. The forearm is placed in
      neutral or midway between pronation/supination (long axis rotation) with approximately 2/3rds
      of the proximal the entire humerus is supported by the table. A towel will be placed under
      the humerus so the elbow is approximately at the level of the shoulder. In order to achieve
      this position, participants will be instructed via the following script:

        1. Lie on your back on the plinth.

        2. Move to the edge of the plinth towards me.

        3. Let me position your arm and put a towel under it.

        4. Bring your arm back towards the table, into external rotation, until you feel like you
           can't go any farther

        5. Hold this position.

      For the standard goniometer measurement, the axis of the goniometer will be placed on the
      center of the olecranon and the stationary arm of the goniometer will be perpendicular with
      the floor and the moving arm will bisect the ulna towards the ulnar styloid process. For
      DrGoniometer, a photo will be taken of the participant at the end of normal active ROM and
      the amount of range of motion will be calculated using the app. For GetMyROM, the iPhone will
      be placed perpendicular to the ground, as determined by the tester, and then the edge of the
      iPhone will be placed on the caudal border of the ulna. Expected normal range of motion is
      approximately 90 degrees of external rotation. The testers will be watching for movement
      substitutions: elbow extension (straightening), scapular elevation, tilting or protraction.
      If the tester notices any compensatory movement patterns, the participant will be asked to
      return to neutral and repeat the movement without compensation.

      3 Three different iPhones will be used. These iPhones belong to the investigators. They will
      all be iPhone 4 version. All iPhone wireless and 3G connections will be disabled prior to
      data collection in order to reduce potential loss of confidentiality. All iPhones will use
      the same version of the applications and will not perform any updates to these applications.
      All iPhones will have the same version of software and will not update the software on the
      iPhone during the study. All iPhones will be password protected in order to reduce potential
      loss of confidentiality. At the end of each testing session, one of the PT investigators will
      assure that the photos have been deleted prior to reestablishing connectivity with the
      internet. In addition, all investigators signed a confidentiality statement.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Texas Woman's University students from the School of Physical Therapy - Houston campus will
        be recruited to participate in this study.
      
Keywords: goniometry; outcome measures; shoulder assessment