Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study
- Conditions
- Chemotherapy-Related Cognitive ImpairmentHealthy
- Interventions
- Other: Usability study
- Registration Number
- NCT04839588
- Lead Sponsor
- Bright Cloud International Corp
- Brief Summary
Develop a game-based upper-extremity motor and cognitive rehabilitation system using custom and adaptable virtual reality simulations.
Perform usability study on 2 elderly healthy volunteers and 2 breast cancer survivors with lasting cognitive impairments following chemotherapy, so to improve the product design. The usability evaluation will be done at NJ Bioscience Center (North Brunswick, NJ).
- Detailed Description
The study will generate data on ease of use of a system for subjects with stage II or stage III breast cancer survivors with lasting cognitive impairments subsequent to their first chemotherapy regimen. The usability component will uncover technical issues in its usability, as well as its rating on perceived usefulness. Data will also be collected on the ease of remote monitoring of the subjects by clinicians.
This portion of the study is intended to provide information pertaining to the usability of the experimental system for remote integrative (cognitive and motor) therapy of breast cancer survivors (Stage II or III) with lasting chemotherapy related cognitive impairment (CRCI) subsequent to first chemotherapy regimen, living in the community.
Specific aims are:
1. testing of a added biosensors, new technology acceptance and ease of use at home by these individuals;
2. a caregiver console and enhanced automatic session report that will allow remote monitoring of patient exercising and offline data processing and review.
Participants will each perform 4 usability evaluation sessions. At the end of each session participants will fill a custom evaluation form, using 5-point Likert scale scoring. At the end of the last session participants will also fill a USE standardized usability evaluation form.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 4
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Usability study, healthy volunteers and those with cognitive impairments following chemotherapy Usability study 2 elderly healthy volunteers and 2 participants with lasting cognitive impairments following chemotherapy for breast cancer. All will perform evaluation of a computer-based experimental system. Participants will be * Female Either healthy or breast cancer survivor; * Age 20 to 65 years; * Have st least 12 years of formal education; * Be English speakers;
- Primary Outcome Measures
Name Time Method USE questionnaire to assess the usability of a computerized system At the end of the 4th evaluation session (about 1 month from enrollment) A standardized questionnaire to assess the usefulness, satisfaction and ease of use of the experimental system \[Lund, 2001\] when evaluated by study participants. The form consists of 30 questions, each rated on a 7-point Likert scale (1 worst 7 best). The score range for this form is 30 (min) to 210 (max).
Participants will also be able to comment in free form on aspects they liked most and least about the device.
- Secondary Outcome Measures
Name Time Method Subjective rating questionnaire of the device and therapy At each of 4 evaluation sessions over 1 month from enrollment Participants rate the usefulness, satisfaction issues, and ease of use of the experimental system and its therapeutic games, as well as ease of use of the Caregiver laptop. The Subjective Evaluation Form consists of questions, each rated on a 5-point Likert scale (1 worst to 5 best outcome).
Trial Locations
- Locations (2)
Bright Cloud Int'l Corp
🇺🇸North Brunswick, New Jersey, United States
New Jersey Bioscience Center
🇺🇸North Brunswick, New Jersey, United States