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Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04839588
Study type Observational
Source Bright Cloud International Corp
Contact
Status Completed
Phase
Start date June 7, 2021
Completion date December 31, 2021

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