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Clinical Trials/NCT04839588
NCT04839588
Completed
Not Applicable

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

Bright Cloud International Corp2 sites in 1 country4 target enrollmentJune 7, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chemotherapy-Related Cognitive Impairment
Sponsor
Bright Cloud International Corp
Enrollment
4
Locations
2
Primary Endpoint
USE questionnaire to assess the usability of a computerized system
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 7, 2021
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

USE questionnaire to assess the usability of a computerized system

Time Frame: 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 Outcomes

  • Subjective rating questionnaire of the device and therapy(At each of 4 evaluation sessions over 1 month from enrollment)

Study Sites (2)

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