Telerehabilitation Alzheimer's Disease Feasibility (TADF)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Alzheimer Disease
- Healthy Aging
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Pilot RCT. Participants are randomized equally into the experimental group and a wait-list control group. Randomization will be based on a randomization table prepared by a contracted bio-statistician.Masking: Single (Outcomes Assessor)Masking Description: Outcomes Assessor will not be told which group the participant is part of, so not be biased in evaluations.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 65 years and 85 years
- Gender
- Both males and females
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 moto...
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.
Tracking Information
- NCT #
- NCT04732182
- Collaborators
- National Institute on Aging (NIA)
- Rutgers, The State University of New Jersey
- Investigators
- Principal Investigator: Grigore C. Burdea, PhD Bright Cloud International