Telerehabilitation Alzheimer's Disease Feasibility (TADF) (TADF)

  • STATUS
    Recruiting
  • days left to enroll
    84
  • participants needed
    14
  • sponsor
    Bright Cloud International Corp
Updated on 31 May 2022
aricept
exelon
Accepts healthy volunteers

Summary

This is a pilot RCT with equal arms: experimental arm and (wait list) control arm.
All participants will be in the early stage of Alzheimer's disease and on stable medication. They will all continue with this medication for their 6 months participation.
Experimental group will add weekly training on the experimental device, 5 days a week for 12 weeks. Training will involve therapeutic games aimed primarily at the memory cognitive domain. All participants will receive weekly calls from clinical coordinator and report on medication and overall health. Caregivers will also be enrolled so they support the trials.

Description

Participants will be randomized equally into an experimental group and a wait list control group.
Experimental training will occur in the home, and will last 12 weeks, each week having 5 sessions of therapeutic game play. Each session will start with vitals being measured and logged followed by motor and biosensor baselines. Subsequently, participants will play an increasing number of games, targeted at the major cognitive domains of memory (primarily), attention and executive functions. Since sessions will increase in length, researchers expect that more than 10 short games may eventually be played in each session.
This will be an ABAA protocol for the experimental group, and a AABA protocol for the wait-list control group. Data will be sampled at baseline (A), during each rehabilitation session (B), mid-way through the study (at 3 months from baseline) and at the end of the study, at 6 months from baseline (A).
At the end of every 4 weeks of BrightGo training, the participant and caregiver will each fill a custom subjective evaluation questionnaire.
Before crossover to the experimental protocol, participants in the wait-list group will continue with their daily routine and prescribed medication (which will be logged). After crossing over, they will add the BrightGo intervention to their daily routine.
Participants initially randomized to the experimental group will continue with daily routine and medication, and add the 5 sessions per week of experimental therapy. Once they cross over to the control arm after 12 weeks from start, they will continue with their daily routine and prescribed medication (which will again be logged) for another 12 weeks.
All participants will receive a weekly call from the Clinical Coordinator so to report on any health concerns and system issues, as well as medication use. Caregivers will also be enrolled so they support the trials.

Details
Condition Alzheimer's Disease, Healthy Aging
Treatment BrightGo cognitive training, Standard of Care medication for early Alzheimer's Disease
Clinical Study IdentifierNCT04732182
SponsorBright Cloud International Corp
Last Modified on31 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Living in the community in Central Jersey so to facilitate researchers travel to home for system installation and/or repairs
Living with a caregiver willing to support trials and be present during sessions
Good upper extremity motor function, close to full range of movement of arms and fingers

Exclusion Criteria

Those younger than 65
Participating in other research studies
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
Those who are not cooperative with the evaluations pre-study
Those who cannot produce reliable scores on the neuropsychological pre-study assessment because they do not comprehend the test, or have severe speech impairment
Those not living with a caregiver willing to support trials, and caregiver unwilling or unable to be present during sessions
Those that are unwilling allow home inspections to ascertain internet conditions in the home, to determine best placement for the experimental system, to install and remove system, and to provide repairs if needed
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