Lower Urinary Tract Symptoms Clinical Trial
Official title:
End User Assessment of Urological Biofeedback Game Software
NCT number | NCT02758938 |
Other study ID # | 2015-0235 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | September 2018 |
Verified date | January 2019 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this study is to test the usability of updated biofeedback game software
developed to help train the muscles involved in lower urinary tract dysfunction (LUTD)
through electromyography (EMG) controlled video games.
A Windows-DOS based biofeedback game system is currently used at the investigator's
institution to help treat LUTD in pediatric patients. This system, however, is outdated and
needs to be replaced with updated hardware and software. A new updated system was recently
created by University of Wisconsin-Madison (UW) Biomedical Engineering students. This system
utilizes a FDA approved EMG device (SRS Medical Aware™ EMG Dual Muscle Monitor) paired with
biofeedback game software that was developed by the students. The investigators wish to test
the usability of the new software to identify areas that need improvement to make the
software more user-friendly.
This study will evaluate the end users' (i.e., physician, biofeedback nurses, patients)
perception of the updated software. In determining usability, we hope to 1) decrease risk of
end user error; 2) make the software intuitive (easier to use); 3) decrease reliance on the
user manual; 4) decrease need for training; and 5) increase understanding of software
operation. This will be an ongoing study in which we continuously monitor the usability of
the software as it is updated based on end-user feedback. The investigators plan to do all
usability testing under the same IRB protocol. If further testing involves items not
discussed here, a "new change" will be made to the IRB application.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2018 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years and older |
Eligibility |
Inclusion Criteria for Peer Focus Group: • >18 years old Inclusion Criteria for Patients: - 6-18 years of age - Diagnosed with LUTD - Currently undergoing biofeedback in the UW LUTD Program Exclusion Criteria for Patients: - Patients who cannot complete the 6-week training program - Patients receiving other treatment methods for LUTD throughout the program Inclusion Criteria for Nurses (no exclusion criteria): • Currently conducting biofeedback treatment in the UW LUTD Program Inclusion Criteria for Physician (no exclusion criteria): • Oversees biofeedback treatment and the UW LUTD Program |
Country | Name | City | State |
---|---|---|---|
United States | American Family Children's Hospital | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
Herndon CD, Decambre M, McKenna PH. Interactive computer games for treatment of pelvic floor dysfunction. J Urol. 2001 Nov;166(5):1893-8. — View Citation
McKenna PH, Herndon CD, Connery S, Ferrer FA. Pelvic floor muscle retraining for pediatric voiding dysfunction using interactive computer games. J Urol. 1999 Sep;162(3 Pt 2):1056-62; discussion 1062-3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physician Feedback Form | This survey will measure the medical value that the software provides to the physician. The physician will be asked to rate certain items on a scale of 1 to 5 - 1 indicating "strongly agree" and 5 indicating "strongly disagree". Each item must score a 4 or 5 for the software to be considered "usable". | 15 minutes | |
Primary | Nurse Feedback Form | This survey will identify the software's "ease of use" for the nurse. The nurses will be asked to rate certain items on a scale of 1 to 5 - 1 indicating "strongly agree" and 5 indicating "strongly disagree". Each item must score a 4 or 5 for the software to be considered "usable". | 15 minutes | |
Primary | Patient Feedback Form | This survey will identify the patient's satisfaction with the software. The patients will be asked to rate certain items on a scale of 1 to 5 - 1 indicating "strongly agree" and 5 indicating "strongly disagree". Each item must score a 4 or 5 for the software to be considered "usable". | 15 minutes | |
Primary | System Usability Scale (SUS) | This is a validated survey that measures that software's usability. Usability will be defined as a SUS score greater than or equal to 85 (Orfanou et al. 2015). | 15 minutes |
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