Telerehabilitation Alzheimer's Disease Usability (TADU)

NCT ID: NCT04731311

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-29
• Study Completion Date: 2021-09-07

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.

Conditions

Alzheimer Disease; Healthy Aging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Usability Evaluation of the BrightGo system

Participants with rate the device in each of 4 usability evaluation sessions.

Group Type: OTHER

Usability evaluation of BrightGo computerized device for cognitive therapy of individuals with early Alzheimer's Disease

Intervention Type: DEVICE

4 participants with undergo 4 usability evaluations each, inter-spaced by days when researchers will address design changes. 2 participants will be elderly healthy and 2 will have the early Alzheimer's disease. Each session will last up to 1 hour, during which participants will interact with tasks in the form of games. Games will be gradated in level of difficulty, increasing from session to session. They will be played with one game controller or with two controllers while participants wear an all-in-one head mounted display. The degree of cognitive engagement during tasks will be measured with custom biosensors and used in adjusting level of difficulty. Each participant will fill subjective evaluation form and a USE form assessing ease of use, usefulness, and perceived technology issues. Scores will be analyzed and data published, in conjunction with game performance data.

Interventions

Usability evaluation of BrightGo computerized device for cognitive therapy of individuals with early Alzheimer's Disease

4 participants with undergo 4 usability evaluations each, inter-spaced by days when researchers will address design changes. 2 participants will be elderly healthy and 2 will have the early Alzheimer's disease. Each session will last up to 1 hour, during which participants will interact with tasks in the form of games. Games will be gradated in level of difficulty, increasing from session to session. They will be played with one game controller or with two controllers while participants wear an all-in-one head mounted display. The degree of cognitive engagement during tasks will be measured with custom biosensors and used in adjusting level of difficulty. Each participant will fill subjective evaluation form and a USE form assessing ease of use, usefulness, and perceived technology issues. Scores will be analyzed and data published, in conjunction with game performance data.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Good or corrected hearing;
• Good or corrected vision;
• No motor or cognitive impairments;
• English speaker;
• Willing to travel to usability site (NJ Bioscience Center)

• Age 65 to 85;
• Diagnosis of early Alzheimer's (Montreal Cognitive Assessment [MoCA] score of 19-25) [Nasreddine et al 2005].
• English speakers;
• Ability to actively move UE and to flex/extend fingers;
• Stable on Aricept 10 mg daily intake, or Exelon 9.5 mg patch medication
• Able to consent;
• Good or corrected hearing;
• Good or corrected vision;
• Good upper extremity motor function, close to full range of movement of arms and fingers;
• Willing to travel to usability site (NJ Bioscience Center)

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;

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: collaborator

Bright Cloud International Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grigore C Burdea, PhD

Role: PRINCIPAL_INVESTIGATOR

Bright Cloud International Corp

Locations

Bright Cloud Int'l Corp

North Brunswick, New Jersey, United States

Countries

United States

Related Links

http://www.BrightBrainer.com

BCI's corporate site showing therapeutic games used with the device

Other Identifiers

R43AG065035

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Telerehab AD Usability

Identifier Type: -

Identifier Source: org_study_id