Telerehabilitation Alzheimer's Disease Usability (TADU)

Not Applicable

Completed

• Conditions: Alzheimer Disease; Healthy Aging
• Interventions: Device: Usability evaluation of BrightGo computerized device for cognitive therapy of individuals with early Alzheimer's Disease

• Registration Number: NCT04731311
• Lead Sponsor: Bright Cloud International Corp

Brief Summary

Usability evaluation of BrightGo cognitive telerehabilitation system. An experimental system was developed to enhance standard of care (medication effect) for Early Alzheimer's Disease populations. This computerized system will be undergo a usability evaluation by healthy and by elderly participants who are in the early phase of Alzheimer's Disease. Sessions will and with participants filling subjective evaluation questionnaires as well as the USE standardized form. Results will be used to address any uncovered issues before a follow on Pilot RCT Feasibility study. Participants will receive $25 after each evaluation session.

Detailed 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 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.

Study Timeline

• Study First Submitted: 2021-01-23
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-01-29
• Study Start: 2021-07-29
• Primary Completion: 2021-09-07
• Study Completion: 2021-09-07
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

• Those younger than 65;
• Severe visual impairments or legally blind;
• Severe hearing loss or deafness;
• Uncontrolled hypertension (>190/100 mmHg);
• Severe cognitive delay (MoCA <19);
• non-English speakers;
• Those unable to provide consent;
• Unable to move arms and fingers, or with severe arthritis;
• Severe propensity to simulation sickness;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Usability Evaluation of the BrightGo system	Usability evaluation of BrightGo computerized device for cognitive therapy of individuals with early Alzheimer's Disease	Participants with rate the device in each of 4 usability evaluation sessions.

Primary Outcome Measures

Name	Time	Method
USE questionnaire to assess the usability of a computerized system	At each of 4 evaluation sessions over 1 month from enrollment	A standardized questionnaire to assess the usefulness, satisfaction and ease of use of the BrightGo 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 BrightGo system and therapeutic games. Form consists of questions, each rated on a 5-point Likert scale (1 worst to 7 best).

Trial Locations

Locations (1)

Bright Cloud Int'l Corp; 🇺🇸 North Brunswick, New Jersey, United States