Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04526639
Status:
RECRUITING
Last Update Posted:
2023-08-31
First Post:
2020-08-18
Brief Title:
VR Cognitive Rehabiliation for Pediatric TBI
Sponsor:
University of Massachusetts Lowell
Organization:
University of Massachusetts Lowell
Study Overview
Official Title:
Virtual Reality-based Rehabilitation for Pediatric TBI R00 Phase
Status:
RECRUITING
Status Verified Date:
2023-08
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:
Childhood traumatic brain injury TBI poses significant impairment in childrens executive functions EFs for moderate to severe injuries yet interventions specifically designed for childrens EF rehabilitation post-TBI and rigorous clinical trials to establish the efficacy of such interventions remain unavailable In this study the investigators will conduct a randomized clinical trial to evaluate the efficacy of a novel virtual reality VR-based training program for EF rehabilitation for childhood TBI
Detailed Description:
Traumatic brain injury TBI is a leading cause of acquired disability in US children with an estimated 700000 cases every year presenting in 75 of children with trauma and accounting for 70 of deaths from childhood trauma Childhood TBIs often result in significant impairment in cognitive functions1 particularly in core executive functions EFs due to the vulnerability of the frontal lobes especially after a moderate to severe TBI Core EF is composed of three skills inhibitory control working memory and cognitive flexibility These skills are associated with impaired EF behaviors increased attention problems and lower health-related quality-of-life HRQOL However evidence-based EF rehabilitation programs are lacking Although a combination of diverse cognitive interventions may improve childrens EF limited affordability accessibility adherence and generalizability hamper clinically adapting and implementing such interventions in the rehabilitation setting Virtual reality VR offers an exciting alternative strategy for EF rehabilitation of childhood TBI due to its flexibility accessibility and immersive experiences in three dimensions These properties may increase adherence to training and foster an enhanced transfer of learned EF skills to untrained tasks in everyday life Thus far rigor-ous randomized clinical trials RCTs have not been conducted to establish the efficacy of VR-based EF reha-bilitation for childhood TBI
The overall goal of the project is to assess the efficacy of a novel VR-based interactive cognitive training VICT program for EF rehabilitation in children with TBI with the following aims
Aim 1 Examine VICTs efficacy in improving core and daily EF skills among children with TBI
Hypothesis 11 Children in the intervention group will show enhanced improvement over controls in trained VR-based EF tasks and untrained NIH Toolbox tasks from baseline to post-intervention and follow-up visits Hypothesis 12 The intervention group will show better reported daily EF than controls at the follow-up visit Hypothesis 13 Children in the intervention group will show faster improvement than controls in daily-reported EF skills between post-intervention and follow-up visits
Aim 2 Examine VICTs efficacy in reducing attentional problems among children with TBI
Hypothesis 21 Children in the intervention group will show a greater reduction in attentional problems as measured by testing on the Conners Continuous Performance Test 3rd Edition Conners CPT 3TM from baseline to the post-intervention and follow-up visits than controls Hypothesis 22 Children in the intervention group will show fewer everyday attentional problems on the Be-havior Assessment System for Children 3rd Ed BASC-3 self- and parent-ratings of attention at the follow-up visit than controls Hypothesis 23 The direct effect of the VICT program in reducing attention problems will be mediated by childrens EF behaviors as measured by the Behavior Rating Inventory of Executive Function Second Edition BRIEF2 at the follow-up visit
Aim 3 Examine VICTs efficacy in improving HRQOL among children with TBI Hypothesis 31 The intervention group will show higher levels of reported HRQOL than controls at follow-up Hypothesis 32 The direct effect of the VICT program on HRQOL at follow-up will be mediated by childrens EF skills and ratings of EF behaviors and attention at the post-intervention and follow-up visits
The overall goal of the project is to assess the efficacy of a novel VR-based interactive cognitive training VICT program for EF rehabilitation in children with TBI with the following aims
Aim 1 Examine VICTs efficacy in improving core and daily EF skills among children with TBI
Hypothesis 11 Children in the intervention group will show enhanced improvement over controls in trained VR-based EF tasks and untrained NIH Toolbox tasks from baseline to post-intervention and follow-up visits Hypothesis 12 The intervention group will show better reported daily EF than controls at the follow-up visit Hypothesis 13 Children in the intervention group will show faster improvement than controls in daily-reported EF skills between post-intervention and follow-up visits
Aim 2 Examine VICTs efficacy in reducing attentional problems among children with TBI
Hypothesis 21 Children in the intervention group will show a greater reduction in attentional problems as measured by testing on the Conners Continuous Performance Test 3rd Edition Conners CPT 3TM from baseline to the post-intervention and follow-up visits than controls Hypothesis 22 Children in the intervention group will show fewer everyday attentional problems on the Be-havior Assessment System for Children 3rd Ed BASC-3 self- and parent-ratings of attention at the follow-up visit than controls Hypothesis 23 The direct effect of the VICT program in reducing attention problems will be mediated by childrens EF behaviors as measured by the Behavior Rating Inventory of Executive Function Second Edition BRIEF2 at the follow-up visit
Aim 3 Examine VICTs efficacy in improving HRQOL among children with TBI Hypothesis 31 The intervention group will show higher levels of reported HRQOL than controls at follow-up Hypothesis 32 The direct effect of the VICT program on HRQOL at follow-up will be mediated by childrens EF skills and ratings of EF behaviors and attention at the post-intervention and follow-up visits
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