Clinical trial NCT04731311: Telerehabilitation Alzheimer's Disease Usability (TADU)
Official title: Telerehabilitation Combining Virtual Reality Adaptable Games and Drug Therapy for Early Alzheimer's Disease - Usability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Healthy Aging
Keywords: Alzheimer's Disease
Virtual Reality
BrightGo
Head Mounted Display
Aricept
Exelon
Lead sponsor: Bright Cloud International Corp
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
name: Rutgers, The State University of New Jersey
First posted: 2021-01-29
Enrollment: 4
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will perform same protocol consisting of 4 evaluation sessions of the BrightGo device
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria for healthy volunteers:

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

Inclusion Criteria for individuals with early Alzheimer's Disease:

* 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;

Primary outcomes:
measure: USE questionnaire to assess the usability of a computerized system
timeFrame: At each of 4 evaluation sessions over 1 month from enrollment
Secondary outcomes:
measure: Subjective rating questionnaire of the device and therapy
timeFrame: At each of 4 evaluation sessions over 1 month from enrollment
Other outcomes:
measure: Simulation Sickness Questionnaire for participant
timeFrame: at enrollment (20 minutes)
measure: Montreal Cognitive Assessment (MoCA) to measure level of cognitive impairment
timeFrame: at enrollment (20 minutes)
measure: Pulse
timeFrame: Before and after each of 4 sessions, over one month from enrollment
measure: Blood pressure
timeFrame: Before and after each of 4 sessions, over one month from enrollment
Locations:
city: North Brunswick
country: United States
facility: Bright Cloud Int'l Corp
state: New Jersey
Study officials:
affiliation: Bright Cloud International Corp
name: Grigore C Burdea, PhD
role: PRINCIPAL_INVESTIGATOR
References: