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VR Cognitive Rehabiliation for Pediatric TBI

Virtual Reality-based Rehabilitation for Pediatric TBI (R00 Phase)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04526639
Enrollment
14
Registered
2020-08-26
Start date
2021-09-03
Completion date
2024-08-31
Last updated
2025-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TBI (Traumatic Brain Injury)

Brief summary

Childhood traumatic brain injury (TBI) poses significant impairment in children's executive functions (EFs) for moderate to severe injuries, yet interventions specifically designed for children's 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 U.S. children, with an estimated 700,000 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,1 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 children's 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 VICT's efficacy in improving core and daily EF skills among children with TBI. Hypothesis 1.1: 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 1.2: The intervention group will show better reported daily EF than controls at the follow-up visit; Hypothesis 1.3: 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 VICT's efficacy in reducing attentional problems among children with TBI. Hypothesis 2.1: 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 2.2: 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 2.3: The direct effect of the VICT program in reducing attention problems will be mediated by children's EF behaviors as measured by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2) at the follow-up visit. Aim 3. Examine VICT's efficacy in improving HRQOL among children with TBI. Hypothesis 3.1: The intervention group will show higher levels of reported HRQOL than controls at follow-up; Hypothesis 3.2: The direct effect of the VICT program on HRQOL at follow-up will be mediated by children's EF skills and ratings of EF behaviors and attention at the post-intervention and follow-up visits.

Interventions

BEHAVIORALVirtual Reality-based Interactive Cognitive Training Program

Three virtual reality-based games designed to train inhibitory control, working memory, and cognitive flexibility among children with TBI

BEHAVIORALPlacebo Virtual Reality Game

A virtual playground for control group to interact without training executive functions

Sponsors

Spaulding Rehabilitation Hospital
CollaboratorOTHER
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
CollaboratorOTHER
University of Massachusetts, Lowell
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

1. diagnosed with TBI within the past 12 months and under 18 years at the time of injury; 2. fluent in English; and 3) Score \<28 on the Agitated Behavior Scale (if available).

Exclusion criteria

1. comorbidities or premorbid disorders that prevent proper administration of VR and study measures, 2. restriction from using electronic devices, 3. post-injury seizure activity.

Design outcomes

Primary

MeasureTime frameDescription
VR-based EF Assessment TaskBaseline (at recruitment/before intervention), Post-Intervention (after completion of intervention, up to 2 weeks), Follow-Up (up to 6 months after completion of intervention)Performance-based executive function assessment Task in the virtual reality environment built by the research team. There are three tasks within this measurement, each transformed into a z score and summed up to serve as the total score for this measure. A Z-score of 0 in each task represents the sample mean. Higher values represent a better outcome for this measure.

Secondary

MeasureTime frameDescription
Report-based EF SkillsFollow-Up (up to 6 months after completion of intervention)Behavior Rating Inventory of Executive Function 2; T scores are used (M = 50, SD = 10, no lower/upper limit), T scores from 60 to 64 are considered mildly elevated, and T scores from 65 to 69 are considered potentially clinically elevated. T scores at or above 70 are considered clinically elevated
Health-related Quality of LifeFollow-Up (up to 6 months after completion of intervention)23-item PedsQL (Pediatric Quality of Life) Generic Core Scales were designed to measure the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. The current study uses its total scores, which is the sum of all 23 items and ranges from 0-100 after transformation. Higher scores indicate better quality of life.
NIH Toolbox Cognition BatteryBaseline (at recruitment/before intervention), Post-Intervention (after completion of intervention, up to 2 weeks), Follow-Up (up to 6 months after completion of intervention)Performance-based executive functions tested by three tasks in the NIH Toolbox Cognition Battery: Dimensional Change Card Sort Test, List Sorting Working Memory Test, and Flanker Inhibitory Control and Attention Test. Scores of each task were computed as age-corrected standard scores automatically by the iPad app of the NIH Toolbox Cognition Battery. Each age-corrected standard score is a z-score with a mean of 100 and standard deviation of 15. Total scores are the mean of all three task age-corrected standard scores. Higher scores represent better outcomes.

Other

MeasureTime frameDescription
Perceived VR ExperiencePost-Intervention, up to 2 weeksVR User Feedback Survey providing subjective feedback on the VR intervention (1-5, higher scores indicate better VR experience)
Motion SicknessPost-Intervention, up to 2 weeksSimulator Sickness Questionnaire, 0-3, higher scores indicate higher levels of motion sickness
Perceived ExertionPost-Intervention, up to 2 weeksBorg Perceived Exertion Scale (6-26, higher score indicates greater exertion)

Countries

United States

Participant flow

Recruitment details

14 participants were recruited during 9/2021 and 8/2024 from two participating sites: Spaulding Rehabilitation Hospital and Kennedy Krieger Institute

Participants by arm

ArmCount
Virtual Reality Games for Training Executive Functions
Virtual Reality games for training three core executive functions
7
Control VR Game on Playground
A relaxing virtual reality game for control group to play in VR playground without training their executive functions
7
Total14

Baseline characteristics

CharacteristicVirtual Reality Games for Training Executive FunctionsControl VR Game on PlaygroundTotal
Age, Continuous12.43 Years
STANDARD_DEVIATION 1.99
13.57 Years
STANDARD_DEVIATION 4.2
13.00 Years
STANDARD_DEVIATION 3.21
Injury Recency73.75 Days
STANDARD_DEVIATION 25.62
129.50 Days
STANDARD_DEVIATION 156.64
101.62 Days
STANDARD_DEVIATION 108.1
Race/Ethnicity, Customized
Black
1 Participants2 Participants3 Participants
Race/Ethnicity, Customized
More than One Race
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
White
6 Participants4 Participants10 Participants
Sex: Female, Male
Female
1 Participants2 Participants3 Participants
Sex: Female, Male
Male
6 Participants5 Participants11 Participants
TBI Severity
Mild Complicated TBI
3 Participants2 Participants5 Participants
TBI Severity
Moderate/Severe TBI
4 Participants5 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 70 / 7
other
Total, other adverse events
0 / 70 / 7
serious
Total, serious adverse events
0 / 70 / 7

Outcome results

Primary

VR-based EF Assessment Task

Performance-based executive function assessment Task in the virtual reality environment built by the research team. There are three tasks within this measurement, each transformed into a z score and summed up to serve as the total score for this measure. A Z-score of 0 in each task represents the sample mean. Higher values represent a better outcome for this measure.

Time frame: Baseline (at recruitment/before intervention), Post-Intervention (after completion of intervention, up to 2 weeks), Follow-Up (up to 6 months after completion of intervention)

Population: Some participants did not have complete/valid data points for baseline, post, or follow-up visits on this outcome and thus excluded from analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Virtual Reality Games for Training Executive FunctionsVR-based EF Assessment TaskPost Intervention1.41 Z-ScoreStandard Deviation 0.77
Virtual Reality Games for Training Executive FunctionsVR-based EF Assessment TaskFollow Up1.71 Z-ScoreStandard Deviation 0.59
Virtual Reality Games for Training Executive FunctionsVR-based EF Assessment TaskPre Intervention1.15 Z-ScoreStandard Deviation 0.55
Control VR Game on PlaygroundVR-based EF Assessment TaskPost Intervention1.53 Z-ScoreStandard Deviation 0.46
Control VR Game on PlaygroundVR-based EF Assessment TaskFollow Up1.82 Z-ScoreStandard Deviation 0.06
Control VR Game on PlaygroundVR-based EF Assessment TaskPre Intervention1.15 Z-ScoreStandard Deviation 0.34
Secondary

Health-related Quality of Life

23-item PedsQL (Pediatric Quality of Life) Generic Core Scales were designed to measure the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. The current study uses its total scores, which is the sum of all 23 items and ranges from 0-100 after transformation. Higher scores indicate better quality of life.

Time frame: Follow-Up (up to 6 months after completion of intervention)

Population: Some participants did not have complete/valid data points for baseline, post, or follow-up visits on this outcome and thus excluded from analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Virtual Reality Games for Training Executive FunctionsHealth-related Quality of LifeParent Report78.88 units on a scaleStandard Deviation 20.89
Virtual Reality Games for Training Executive FunctionsHealth-related Quality of LifeChild Report75.90 units on a scaleStandard Deviation 13.49
Control VR Game on PlaygroundHealth-related Quality of LifeParent Report75.54 units on a scaleStandard Deviation 8.76
Control VR Game on PlaygroundHealth-related Quality of LifeChild Report70.67 units on a scaleStandard Deviation 4.64
Secondary

NIH Toolbox Cognition Battery

Performance-based executive functions tested by three tasks in the NIH Toolbox Cognition Battery: Dimensional Change Card Sort Test, List Sorting Working Memory Test, and Flanker Inhibitory Control and Attention Test. Scores of each task were computed as age-corrected standard scores automatically by the iPad app of the NIH Toolbox Cognition Battery. Each age-corrected standard score is a z-score with a mean of 100 and standard deviation of 15. Total scores are the mean of all three task age-corrected standard scores. Higher scores represent better outcomes.

Time frame: Baseline (at recruitment/before intervention), Post-Intervention (after completion of intervention, up to 2 weeks), Follow-Up (up to 6 months after completion of intervention)

Population: Some participants did not have complete/valid data points for baseline, post, or follow-up visits on this outcome and thus excluded from analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Virtual Reality Games for Training Executive FunctionsNIH Toolbox Cognition BatteryPost Intervention91.11 Z-scoreStandard Deviation 11.83
Virtual Reality Games for Training Executive FunctionsNIH Toolbox Cognition BatteryFollow Up90.87 Z-scoreStandard Deviation 11.25
Virtual Reality Games for Training Executive FunctionsNIH Toolbox Cognition BatteryPre Intervention87.67 Z-scoreStandard Deviation 10.26
Control VR Game on PlaygroundNIH Toolbox Cognition BatteryPost Intervention90.87 Z-scoreStandard Deviation 11.25
Control VR Game on PlaygroundNIH Toolbox Cognition BatteryFollow Up88.83 Z-scoreStandard Deviation 20.06
Control VR Game on PlaygroundNIH Toolbox Cognition BatteryPre Intervention83.56 Z-scoreStandard Deviation 12.59
Secondary

Report-based EF Skills

Behavior Rating Inventory of Executive Function 2; T scores are used (M = 50, SD = 10, no lower/upper limit), T scores from 60 to 64 are considered mildly elevated, and T scores from 65 to 69 are considered potentially clinically elevated. T scores at or above 70 are considered clinically elevated

Time frame: Follow-Up (up to 6 months after completion of intervention)

Population: Some participants did not have complete/valid data points for baseline, post, or follow-up visits on this outcome and thus excluded from analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Virtual Reality Games for Training Executive FunctionsReport-based EF SkillsParent Report52.00 PointsStandard Deviation 6.82
Virtual Reality Games for Training Executive FunctionsReport-based EF SkillsChild Report51.75 PointsStandard Deviation 12.42
Control VR Game on PlaygroundReport-based EF SkillsParent Report50.25 PointsStandard Deviation 8.81
Control VR Game on PlaygroundReport-based EF SkillsChild Report49.67 PointsStandard Deviation 4.51
Other Pre-specified

Motion Sickness

Simulator Sickness Questionnaire, 0-3, higher scores indicate higher levels of motion sickness

Time frame: Post-Intervention, up to 2 weeks

ArmMeasureValue (MEAN)Dispersion
Virtual Reality Games for Training Executive FunctionsMotion Sickness0.09 PointsStandard Deviation 0.13
Control VR Game on PlaygroundMotion Sickness0.24 PointsStandard Deviation 0.26
Other Pre-specified

Perceived Exertion

Borg Perceived Exertion Scale (6-26, higher score indicates greater exertion)

Time frame: Post-Intervention, up to 2 weeks

ArmMeasureValue (MEAN)Dispersion
Virtual Reality Games for Training Executive FunctionsPerceived Exertion7.38 PointsStandard Deviation 1.24
Control VR Game on PlaygroundPerceived Exertion9.71 PointsStandard Deviation 5.06
Other Pre-specified

Perceived VR Experience

VR User Feedback Survey providing subjective feedback on the VR intervention (1-5, higher scores indicate better VR experience)

Time frame: Post-Intervention, up to 2 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Virtual Reality Games for Training Executive FunctionsPerceived VR ExperienceVR Quality2.50 PointsStandard Deviation 1.05
Virtual Reality Games for Training Executive FunctionsPerceived VR ExperiencePleasure3.25 PointsStandard Deviation 1.33
Virtual Reality Games for Training Executive FunctionsPerceived VR Experiencemotivation-Like to use VR again3.17 PointsStandard Deviation 0.93
Virtual Reality Games for Training Executive FunctionsPerceived VR Experiencemotivation-use VR in future2.83 PointsStandard Deviation 1.37
Virtual Reality Games for Training Executive FunctionsPerceived VR Experiencemotivation-use VR in therapies3.42 PointsStandard Deviation 1.56
Virtual Reality Games for Training Executive FunctionsPerceived VR Experiencemotivation-attend3.08 PointsStandard Deviation 1.5
Control VR Game on PlaygroundPerceived VR Experiencemotivation-use VR in therapies3.50 PointsStandard Deviation 1.52
Control VR Game on PlaygroundPerceived VR ExperienceVR Quality3.08 PointsStandard Deviation 1.28
Control VR Game on PlaygroundPerceived VR Experiencemotivation-use VR in future3.37 PointsStandard Deviation 1.21
Control VR Game on PlaygroundPerceived VR ExperiencePleasure3.92 PointsStandard Deviation 1.02
Control VR Game on PlaygroundPerceived VR Experiencemotivation-attend3.00 PointsStandard Deviation 1.67
Control VR Game on PlaygroundPerceived VR Experiencemotivation-Like to use VR again3.92 PointsStandard Deviation 1.2

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026