Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04732182
Status:
UNKNOWN
Last Update Posted:
2022-05-02
First Post:
2021-01-25
Brief Title:
Telerehabilitation Alzheimers Disease Feasibility TADF
Sponsor:
Bright Cloud International Corp
Organization:
Bright Cloud International Corp
Study Overview
Official Title:
Telerehabilitation Combining Virtual Reality Adaptable Games and Drug Therapy for Early Alzheimers Disease - Feasibility
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TADF
Brief 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 Alzheimers 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 8 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
All participants will be in the early stage of Alzheimers 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 8 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
Detailed 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 8 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 2 months from baseline and at the end of the study at 4 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 8 weeks from start they will continue with their daily routine and prescribed medication which will again be logged for another 8 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
Experimental training will occur in the home and will last 8 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 2 months from baseline and at the end of the study at 4 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 8 weeks from start they will continue with their daily routine and prescribed medication which will again be logged for another 8 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R43AG065035 | NIH | None | httpsreporternihgovquickSearchR43AG065035 |