NCT04839588

Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study

Home-based Virtual Reality System for the Treatment of Chemotherapy-related Cognitive Impairments

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4 (actual)
• Sponsor: Bright Cloud International Corp · Industry
• Sex: Female
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chemotherapy-Related Cognitive Impairment
• Healthy

Interventions

Type	Name	Description
OTHER	Usability study	Participants will first be screened for propensity to simulation sickness and for cognitive state using the MoCA evaluation test. Those who passed the screening will perform 4 usability sessions rating the ease of use and perceived benefit of the experimental system and of a caregiver interface laptop. The 2 healthy volunteers will evaluate first, such that issues may be resolved before testing is done on the impaired participants. Each session will be compensated with a $35 payment. During each session participants will play a series of increasing difficulty simulated tasks, aimed to train primarily the executive functions domain. At the end of each session participants will rate their experience using custom subjective evaluation forms with multiple items. Each item will be scored using a 5-point Likert scale. At the end of the 4th session, participants will also fill the USE standardized usability form. This usability evaluation will be conducted at the NJ Bioscience Center.

Timeline

• Start date: 2021-06-07
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-04-09
• Last updated: 2022-04-28

Locations

2 sites across 1 country: United States