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Completed

NCT Number: NCT04731311

Telerehabilitation Alzheimer's Disease Usability (TADU)

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.

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bright Cloud Int'l Corp

North Brunswick, New Jersey, 08902, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

Primary outcomes

  1. USE questionnaire to assess the usability of a computerized system

    Time frame: 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 outcomes

  1. Subjective rating questionnaire of the device and therapy

    Time frame: 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).

Other outcomes

  1. Simulation Sickness Questionnaire for participant

    Time frame: at enrollment (20 minutes)

    Form used at screening post-consent to determine a participant's propensity for simulation sickness [Kennedy et al.,1993]. The questionnaire asks participants to score 16 symptoms on a four point scale (0-3). Score range is 0 (best outcome - no likelihood of experiencing simulation sickness with the device) to 48 (worst outcome - certainty participant will experience severe simulation sickness).

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

    Time frame: at enrollment (20 minutes)

    Used at screening post-consent to determine level of cognitive impairment [Nasreddine et al 2005] for participants. The form has a score range from 0 (worst) to 30 (best) - no cognitive impairments. For the participants with early Alzheimer's Disease the form will confirm the participant is in the score range of 19-25.

  3. Pulse

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

    Heart rate measured with medical meter

  4. Blood pressure

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

    Systolic and Diastolic blood pressure will be measured with medical meter

Sponsors and collaborators

Lead sponsor

Bright Cloud International Corp

Industry

Collaborators

  • National Institute on Aging (NIA)
  • Rutgers, The State University of New Jersey

Registry information

Official study title

Telerehabilitation Combining Virtual Reality Adaptable Games and Drug Therapy for Early Alzheimer's Disease - Usability

Acronym: TADU

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 29, 2021
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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