Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Alzheimer Disease
  • Healthy Aging
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: All participants will perform same protocol consisting of 4 evaluation sessions of the BrightGo deviceMasking: None (Open Label)Masking Description: No MaskingPrimary Purpose: Other

Participation Requirements

Age
Between 65 years and 85 years
Gender
Both males and females

Description

Study will start with 2 elderly healthy volunteers (one male and one female) with preference to those with no computer game experience. The healthy volunteers will each perform usability sessions (2 times per week) in the first 2 weeks. They will be instructed to move the arms, grasp and extend fing...

Study will start with 2 elderly healthy volunteers (one male and one female) with preference to those with no computer game experience. The healthy volunteers will each perform usability sessions (2 times per week) in the first 2 weeks. They will be instructed to move the arms, grasp and extend fingers, so to mimic the assumed functionality during subsequent feasibility component. The usability subjects will test the game controller movement, the caregiver tablet interface, and test all therapeutic games. Each of the games will be tested at all levels of difficulty, so to detect any previously unknown bugs. They will further test system wireless communication and real-time graphics response to controller input (minimal lag and lack of freezing, smooth avatar control). Finally, they will test the set motor and cognitive baseline procedures, meant to adapt games to participant. Specifically, this research team has developed a relaxing scene to be shown to participants while their biosensors are measured. This will help interpret any changes occurring subsequently, during therapeutic game interactions so to get an indication of engagement, or lack of, with the game tasks. At the end of each session, volunteers will fill in the USE standardized usability questionnaire [Lund 2001]. This questionnaire will rate the usefulness, ease of use, ease of learning, and satisfaction with the BrightGo system. The USE form will solicit comments on games instructions, ergonomic issues with the new hand controllers, and degree of assistance needed. Sessions will be inter-spaced with days when the programmer, engineer and our Research Therapist will address issues uncovered in the previous session(s). The usability evaluation process will be repeated in the subsequent 2 weeks with two participants in the early phase of Alzheimer's disease. Their performance will be compared with that of the elderly healthy volunteers, so to better gauge the usability of the BrightGo system for the targeted population. The Usability study will inform necessary BrightGo system improvements prior to feasibility study. Participants with early phase of Alzheimer's disease will not test the caregiver tablet. Usability participants will be paid $25/session.

Tracking Information

NCT #
NCT04731311
Collaborators
  • National Institute on Aging (NIA)
  • Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Grigore C Burdea, PhD Bright Cloud International Corp