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临床试验/NCT02758938
NCT02758938已完成不适用

End User Assessment of Urological Biofeedback Game Software

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Nurse Feedback Form

研究概览

简要总结

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 This system, however, is outdated and needs to be replaced with updated hardware and software.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

详细描述

BACKGROUND AND SIGNIFICANCE

Medical and Biological:

LUTD is a common problem in children that can result in wetting during the day and night, frequent and urgent urination and urinary tract infections. In a subset of children, LUTD is the result of dis-coordination between pelvic floor and abdominal muscles. These children tend to contract their pelvic muscles rather than relax them during voiding. This abnormal contraction results in bladder changes that can result in incontinence. In most cases, understanding how to contract and relax the pelvic floor and abdominal muscles can help reduce LUTD symptoms. Identifying and learning how to utilize the pelvic floor without abdominal muscle activation is one of the most powerful effectors of bladder function.

The current LUTD Program at the investigator's institution includes a full history and physical exam followed by extensive education. If the patients do not improve they undergo additional evaluation with a renal pelvic ultrasound and simultaneous uroflowmetry and electromyography (EMG) study. Based on that evaluation a percentage of patients go on to receive biofeedback treatment. Biofeedback is typically recommended to patients who do not use the pelvic floor and abdominal muscles appropriately while voiding. The biofeedback treatment involves further education, standard biofeedback, and biofeedback computer games. In standard biofeedback, patients are made aware of their abdominal and pelvic floor muscle activity by a display that shows the abdominal and pelvic floor muscles' EMG activity. In the biofeedback computer games, patients control a variety of games with their pelvic floor and abdominal muscles. Both methods teach the patient how to locate the pelvic floor muscles and to isolate them while voiding. Biofeedback represents only one possible treatment plan for children with LUTD. Patients are analyzed prior to entering the biofeedback portion of the LUTD Program for compatibility with this treatment.

Several studies were conducted by McKenna and colleagues to assess the effectiveness of the biofeedback games on treating LUTD symptoms.The trials involved 41 and 160 children of varying ages that averaged out to be 7.2 and 8.5 years respectively. The games worked by acquiring feedback that represented a flexion of the pelvic floor and relaxation of the abdominal muscle. All of the children in the trials participated in approximately an hour of treatment per session that involved around 20 minutes of supervised gaming time. The 84% and 87% success rate in each trial showed that the method of using biofeedback paired with the video games is a viable option for the treatment of LUTD in children.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Patient Subjects

Experimental

Patients that are part of the UW LUTD Program (n=30) will undergo 3 weekly biofeedback sessions each lasting 1 hour. All interactive biofeedback sessions will be conducted by American Family Children's Hospital nurses that are experienced in standard biofeedback techniques. After the patient has completed all of the biofeedback sessions, he/she will complete a feedback form about their satisfaction with the device.

干预措施: Urologic biofeedback software (Other)

Biofeedback Nurse Subjects

Experimental

The nurses (n=3) involved in the biofeedback portion of the UW LUTD Program will undergo a Nurse Training Session where they will be asked to "think aloud" while completing an outlined scenario. Their feedback will be used to update the software to make it more user friendly. After the session, they will be asked to complete the System Usability Scale (SUS). Additionally, after guiding patients through biofeedback sessions using the new software, they will be asked to complete the Nurse Feedback Form.

干预措施: Urologic biofeedback software (Other)

Biofeedback Physician Subject

Experimental

The physician (n=1) that oversees the UW LUTD Program will assess data from each patients session. Based on the information he gathers from the session, he will complete a feedback form. Each patient's EMG activity will be stored by the video game which will allow the physician to review the patient's performance. Specifically, the physician will look for the minimum relaxation and the maximum contraction levels of the patient throughout play as well as muscular isolation.

干预措施: Urologic biofeedback software (Other)

Focus Group Subjects

Experimental

A Focus Group session will involve the physician involved in this study, an advisor on the project and staff involved in the project as well as three random individuals outside of the project (n=7). These individuals will provide feedback on the software that will be used to improve the software.

干预措施: Urologic biofeedback software (Other)

结局指标

主要结局

Nurse Feedback Form

时间窗: 15 minutes

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".

Physician Feedback Form

时间窗: 15 minutes

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".

Patient Feedback Form

时间窗: 15 minutes

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".

System Usability Scale (SUS)

时间窗: 15 minutes

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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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