Ignite Creation Date:
2024-05-06 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03611062
Status:
COMPLETED
Last Update Posted:
2021-09-14
First Post:
2018-06-15
Brief Title:
VR-based EF Rehabilitation for Pediatric TBI
Sponsor:
University of Massachusetts Lowell
Organization:
University of Massachusetts Lowell
Study Overview
Official Title:
A Pilot Study on Virtual Reality-based Rehabilitation for Children With Traumatic Brain Injuries
Status:
COMPLETED
Status Verified Date:
2021-08
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 safety and efficacy of such interventions remain unavailable In this study the investigators will conduct a small-scale pilot randomized clinical trial to evaluate the safety and preliminary efficacy of a novel virtual reality VR-based training program for EF rehabilitation for mild complicated to severe childhood TBI Knowledge from this research will provide empirical evidence for a larger-scale RCT after the conclusion of this pilot study with the aim to improve the long-term health and quality of life in children with TBI as well as promote efficiency and effectiveness of future psychological rehabilitation for children with 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 functions 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 whose impairment is associated with impaired daily EF skills increased attention problems and lower quality-of-life QoL The CDC reported to Congress in 2015 that post-TBI cognitive rehabilitation was the No 1 unmet health care need for children with TBI However evidence-based EF rehabilitation programs are lacking Although research has shown that a combination of diverse cognitive interventions may improve childrens EF clinically adapting and implementing such interventions in the rehabilitation setting is hampered by limited affordability accessibility adherence and generalizability Virtual reality VR offers an exciting alternative strategy for EF rehabilitation of childhood TBI for three reasons First VR has the flexibility to offer various EF training activities in a virtual environment within a restricted physical space Second VR can be delivered via Internetmobile platforms allowing children to participate in post-discharge training at home as needed Third unlike traditional computerized training programs VR can provide immersive experiences in three dimensions This may increase adherence to training and foster greater transfer of learned EF skills to untrained tasks in everyday life Thus far rigorous randomized clinical trials RCTs have not been conducted to establish the safety and efficacy of VR-based EF rehabilitation for childhood TBI
The overall goal of this pilot project is to assess the feasibility safety and preliminary efficacy of a novel VR-based interactive cognitive training VICT program for EF rehabilitation in children ages 7-17 years with complicated mild to severe TBI The VICT program is an integrative hardware and software VR system that trains the three core EFs within a challenging animated mission Using a small parallel-group RCT the study focuses on refining clinically-appropriate VR research paradigms in pediatric rehabilitation settings and obtaining feasibility safety and preliminary efficacy data on childrens EF improvement After the conclusion of the present pilot study the investigators will utilize the knowledge and skills gained from this phase to conduct a full-scale longitudinal parallel-group RCT to formally evaluate the VICT programs efficacy
Specifically a small parallel-group RCT will be carried out in this study The investigators aim to recruit 20-30 children with complicated mild to severe TBI and randomly assign each participant to either an intervention group VICT or a control group comparable VR game without EF training Preliminary efficacy outcomes will be assessed at pre- post-intervention and a follow-up visit up to six months after the post-intervention assessment
Aim 1 Refine clinically-appropriate paradigms for VR childhood TBI rehabilitation research
Aim 2 Explore feasibility safety and preliminary efficacy of the VICT program The feasibility and safety of the VICT program will be examined through both quantitative measures adverse events simulator sickness and fatigability and a semi-structured interview with children families and clinicians regarding perceived benefits and challenges Preliminary efficacy data will be obtained on core EF daily EF attention problems and health-related QoL for both groups These data will then be used in a conservative way to estimate the effect size of this novel intervention and calculate the required sample size for future RCTs
The overall goal of this pilot project is to assess the feasibility safety and preliminary efficacy of a novel VR-based interactive cognitive training VICT program for EF rehabilitation in children ages 7-17 years with complicated mild to severe TBI The VICT program is an integrative hardware and software VR system that trains the three core EFs within a challenging animated mission Using a small parallel-group RCT the study focuses on refining clinically-appropriate VR research paradigms in pediatric rehabilitation settings and obtaining feasibility safety and preliminary efficacy data on childrens EF improvement After the conclusion of the present pilot study the investigators will utilize the knowledge and skills gained from this phase to conduct a full-scale longitudinal parallel-group RCT to formally evaluate the VICT programs efficacy
Specifically a small parallel-group RCT will be carried out in this study The investigators aim to recruit 20-30 children with complicated mild to severe TBI and randomly assign each participant to either an intervention group VICT or a control group comparable VR game without EF training Preliminary efficacy outcomes will be assessed at pre- post-intervention and a follow-up visit up to six months after the post-intervention assessment
Aim 1 Refine clinically-appropriate paradigms for VR childhood TBI rehabilitation research
Aim 2 Explore feasibility safety and preliminary efficacy of the VICT program The feasibility and safety of the VICT program will be examined through both quantitative measures adverse events simulator sickness and fatigability and a semi-structured interview with children families and clinicians regarding perceived benefits and challenges Preliminary efficacy data will be obtained on core EF daily EF attention problems and health-related QoL for both groups These data will then be used in a conservative way to estimate the effect size of this novel intervention and calculate the required sample size for future RCTs
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 |
|---|---|---|---|
| 1K99HD093814-01A1 | NIH | None | httpsreporternihgovquickSearch1K99HD093814-01A1 |