Telerehabilitation Alzheimer's Disease Usability (TADU)

NCT04731311 | Completed DMC

• 2 other identifiers: Telerehab AD UsabilityR43AG065035
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Healthy Aging

Keywords

Alzheimer's Disease; Virtual Reality; BrightGo; Head Mounted Display; Aricept; Exelon

Outcome Measures

Primary Outcomes (1)

• USE questionnaire to assess the usability of a computerized system

  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.

  At each of 4 evaluation sessions over 1 month from enrollment

Secondary Outcomes (1)

• Subjective rating questionnaire of the device and therapy

  At each of 4 evaluation sessions over 1 month from enrollment

Other Outcomes (4)

• Simulation Sickness Questionnaire for participant

  at enrollment (20 minutes)

• Montreal Cognitive Assessment (MoCA) to measure level of cognitive impairment

  at enrollment (20 minutes)

• Pulse

  Before and after each of 4 sessions, over one month from enrollment

Study Arms (1)

Usability Evaluation of the BrightGo system

OTHER

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

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

Interventions

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

Usability Evaluation of the BrightGo system

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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;

Sponsors & Collaborators

• Bright Cloud International Corp: lead
• National Institute on Aging (NIA): collaborator
• Rutgers, The State University of New Jersey: collaborator

Study Sites (1)

Bright Cloud Int'l Corp

North Brunswick, New Jersey, 08902, United States

Location

Related Links

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

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Grigore C Burdea, PhD

  Bright Cloud International Corp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No Masking
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will perform same protocol consisting of 4 evaluation sessions of the BrightGo device

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: January 29, 2021
• Study Start: July 29, 2021
• Primary Completion: September 7, 2021
• Study Completion: September 7, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)