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Urological Biofeedback Game Software

NCT02758938 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-01-09

No results posted yet for this study

Summary

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 This system, however, is outdated and needs to be replaced with updated hardware and software.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.

Conditions

  • Lower Urinary Tract Symptoms

Interventions

OTHER

Urologic biofeedback software

All subjects (end users) will be walked through the urologic biofeedback software training suite. Each end user will follow a protocol that is specific to their role. Upon completing their session(s) with the software, each end user will provide appropriate feedback.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-01-31
Completion
2018-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02758938 on ClinicalTrials.gov