Validation Testing

Studies including Human Subjects

Prior to the start of validation testing, the team applied for and was granted approval for studies including human subjects by the college’s Institutional Review Board (IRB #:  IRB-2022-0448)

This approval allowed us to perform validation tests for the requirements relating to guidance, range of motion, comfort and fit of the Epley Maneuver System. 

Design Input 1 – Validation

  • Testing if user feedback is comprehensible
    • Human studies survey question
    • 10 participants
  • 1-10 scale, with 1 being undecipherable and 10 being very clear
  • Average user response: 3.2
  • Acceptance criteria required a 7 or greater
  • Validation for design input 1 failed due to the volume of the device being too low. This was caused by the nature of the library used that had a low volume, even audio amplification was unable to resolve this issue, but in the future we hope to find a better solution.

Design Input 2 – Validation

  • Testing if range of motion is accessible
    • Human studies survey question
  • Yes or No question
    • If full range of motion was reached
  • 10/10 Answered Yes 
    • Binomial test done (p < 0.05)
  • Validation for design input 2 passed

Design Input 3 – Validation

Figure 21. Plots of x, y and z angles through treatment session done on simulated head. Done for whole treatment session including calibration, steps 1, 2 and 3

This validation test related to the recreation of the steps in the Epley maneuver while utilizing the Epley Maneuver System

Design Input 4 – Validation

  • Testing whether or not feedback was administered
  • Yes or No question
    • Depending on whether or not feedback was administered throughout the entire Epley maneuver
  • Result was Yes 
  • Validation for design input 4 passed

Design Input 5 – Validation

  • Testing if the data recorded on the accelerometer is transmitted properly into an Excel spreadsheet.
  • Yes or No question
    • Depending on whether or not data was recorded throughout an Epley maneuver session
  • Result was Yes 
  • Validation for design input 5 passed

Design Input 6 – Validation

  • Testing if the amount of data points on the spreadsheet, matched the value at the end of the spreadsheet, to make sure everything transferred over properly. 
  • Yes or No question
    • Depending on whether or not data transferred throughout an Epley maneuver session
  • Result was Yes 
  • Validation for design input 6 passed

Design Input 7 – Validation

  • Testing whether or not the device was actively powered for 20 minutes
  • Yes or No question
    • Dependant on whether or not the Epley Maneuver System was actively powered throughout an entire treatment session, or 20 minutes 
  • Result was Yes 
  • Validation for design input 7 passed

Design Input 8 – Validation

  • Testing whether or not the device fit the patient
    • Human studies survey question
    • 10 participants
  • 1-10 scale, with 1 not fitting at all and 10 being a perfect fit
  • Average user response: 9.1
  • Acceptance criteria required a 7 or greater
  • Validation for design input 8 passed

Design Input 9 – Validation

  • Testing whether or not the device was comfortable for the patient to wear
    • Human studies survey question
    • 10 participants
  • 1-10 scale, with 1 not fitting at all and 10 being a perfect fit
  • Average user response: 8.8
  • Acceptance criteria required a 5 or greater
  • Validation for design input 9 passed

Design Input 10 – Validation

  • Validating that the values for touch current and earth leakage current from DI10 verification abide by the standard. 
  • They both were significantly less than the maximum values provided by the IEC.
  • Validation for design input 10 passed