Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04920123
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2021-06-03
Brief Title:
Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic
Sponsor:
University of Massachusetts Amherst
Organization:
University of Massachusetts Amherst
Study Overview
Official Title:
Towards the Development of a Mobile-health Technology Designed to Encourage the Use of Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
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:
None
Brief Summary:
This study will evaluate the therapeutic efficacy of Neuro-World cognitive training games Woorisoft S Korea in patients with mild cognitive impairment
Detailed Description:
This study will be a cross-over randomized controlled trial
Fifty participants will be enrolled and randomly assigned to group A or group B
Group A will self-administer Neuro-World cognitive training games for 30 minutes a day twice a week for 12 weeks in the home setting ie intervention period For the following 12 weeks the participants will not engage in any therapist-supervised cognitive therapies ie no-intervention period
Group B will not engage in any therapist-supervised cognitive therapies ie no-intervention period For the following 12 weeks the participants will self-administer Neuro-World cognitive training games for 30 minutes a day twice a week in the home setting ie intervention period
All the participants in both groups will receive phone calls twice a week to 1 provide feedback on their adherence to Neuro-World cognitive training during the intervention period and 2 learn any significant changes in the level of their daily activities during the no-intervention period and the intervention period
Fifty participants will be enrolled and randomly assigned to group A or group B
Group A will self-administer Neuro-World cognitive training games for 30 minutes a day twice a week for 12 weeks in the home setting ie intervention period For the following 12 weeks the participants will not engage in any therapist-supervised cognitive therapies ie no-intervention period
Group B will not engage in any therapist-supervised cognitive therapies ie no-intervention period For the following 12 weeks the participants will self-administer Neuro-World cognitive training games for 30 minutes a day twice a week in the home setting ie intervention period
All the participants in both groups will receive phone calls twice a week to 1 provide feedback on their adherence to Neuro-World cognitive training during the intervention period and 2 learn any significant changes in the level of their daily activities during the no-intervention period and the intervention period
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