Trial Outcomes & Findings for VR Cognitive Rehabiliation for Pediatric TBI (NCT NCT04526639)

NCT ID: NCT04526639

Last Updated: 2025-10-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: 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)
• Results posted on: 2025-10-16

Participant Flow

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

Participant milestones

Measure	Virtual Reality Games for Training Executive Functions Virtual Reality games for training three core executive functions	Control VR Game on Playground A relaxing virtual reality game for control group to play in VR playground without training their executive functions
Overall Study STARTED	7	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

VR Cognitive Rehabiliation for Pediatric TBI

Baseline characteristics by cohort

Measure	Virtual Reality Games for Training Executive Functions n=7 Participants Virtual Reality games for training three core executive functions	Control VR Game on Playground n=7 Participants A relaxing virtual reality game for control group to play in VR playground without training their executive functions	Total n=14 Participants Total of all reporting groups
Age, Continuous	12.43 Years STANDARD_DEVIATION 1.99 • n=5 Participants	13.57 Years STANDARD_DEVIATION 4.20 • n=7 Participants	13.00 Years STANDARD_DEVIATION 3.21 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized White	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized More than One Race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
TBI Severity Mild Complicated TBI	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
TBI Severity Moderate/Severe TBI	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Injury Recency	73.75 Days STANDARD_DEVIATION 25.62 • n=5 Participants	129.50 Days STANDARD_DEVIATION 156.64 • n=7 Participants	101.62 Days STANDARD_DEVIATION 108.10 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Virtual Reality Games for Training Executive Functions n=6 Participants Virtual Reality games for training three core executive functions	Control VR Game on Playground n=7 Participants A relaxing virtual reality game for control group to play in VR playground without training their executive functions
VR-based EF Assessment Task Post Intervention	1.41 Z-Score Standard Deviation 0.77	1.53 Z-Score Standard Deviation 0.46
VR-based EF Assessment Task Follow Up	1.71 Z-Score Standard Deviation 0.59	1.82 Z-Score Standard Deviation 0.06
VR-based EF Assessment Task Pre Intervention	1.15 Z-Score Standard Deviation 0.55	1.15 Z-Score Standard Deviation 0.34

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Virtual Reality Games for Training Executive Functions n=6 Participants Virtual Reality games for training three core executive functions	Control VR Game on Playground n=6 Participants A relaxing virtual reality game for control group to play in VR playground without training their executive functions
NIH Toolbox Cognition Battery Post Intervention	91.11 Z-score Standard Deviation 11.83	90.87 Z-score Standard Deviation 11.25
NIH Toolbox Cognition Battery Follow Up	90.87 Z-score Standard Deviation 11.25	88.83 Z-score Standard Deviation 20.06
NIH Toolbox Cognition Battery Pre Intervention	87.67 Z-score Standard Deviation 10.26	83.56 Z-score Standard Deviation 12.59

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Virtual Reality Games for Training Executive Functions n=5 Participants Virtual Reality games for training three core executive functions	Control VR Game on Playground n=4 Participants A relaxing virtual reality game for control group to play in VR playground without training their executive functions
Report-based EF Skills Parent Report	52.00 Points Standard Deviation 6.82	50.25 Points Standard Deviation 8.81
Report-based EF Skills Child Report	51.75 Points Standard Deviation 12.42	49.67 Points Standard Deviation 4.51

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Virtual Reality Games for Training Executive Functions n=5 Participants Virtual Reality games for training three core executive functions	Control VR Game on Playground n=4 Participants A relaxing virtual reality game for control group to play in VR playground without training their executive functions
Health-related Quality of Life Parent Report	78.88 units on a scale Standard Deviation 20.89	75.54 units on a scale Standard Deviation 8.76
Health-related Quality of Life Child Report	75.90 units on a scale Standard Deviation 13.49	70.67 units on a scale Standard Deviation 4.64

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-Intervention, up to 2 weeks

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

Outcome measures

Measure	Virtual Reality Games for Training Executive Functions n=6 Participants Virtual Reality games for training three core executive functions	Control VR Game on Playground n=6 Participants A relaxing virtual reality game for control group to play in VR playground without training their executive functions
Motion Sickness	0.09 Points Standard Deviation 0.13	0.24 Points Standard Deviation 0.26

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-Intervention, up to 2 weeks

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

Outcome measures

Measure	Virtual Reality Games for Training Executive Functions n=6 Participants Virtual Reality games for training three core executive functions	Control VR Game on Playground n=6 Participants A relaxing virtual reality game for control group to play in VR playground without training their executive functions
Perceived Exertion	7.38 Points Standard Deviation 1.24	9.71 Points Standard Deviation 5.06

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-Intervention, up to 2 weeks

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

Outcome measures

Measure	Virtual Reality Games for Training Executive Functions n=6 Participants Virtual Reality games for training three core executive functions	Control VR Game on Playground n=6 Participants A relaxing virtual reality game for control group to play in VR playground without training their executive functions
Perceived VR Experience VR Quality	2.50 Points Standard Deviation 1.05	3.08 Points Standard Deviation 1.28
Perceived VR Experience Pleasure	3.25 Points Standard Deviation 1.33	3.92 Points Standard Deviation 1.02
Perceived VR Experience motivation-Like to use VR again	3.17 Points Standard Deviation 0.93	3.92 Points Standard Deviation 1.20
Perceived VR Experience motivation-use VR in future	2.83 Points Standard Deviation 1.37	3.37 Points Standard Deviation 1.21
Perceived VR Experience motivation-use VR in therapies	3.42 Points Standard Deviation 1.56	3.50 Points Standard Deviation 1.52
Perceived VR Experience motivation-attend	3.08 Points Standard Deviation 1.50	3.00 Points Standard Deviation 1.67

Adverse Events

Virtual Reality Games for Training Executive Functions

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control VR Game on Playground

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jiabin Shen

University of Massachusetts Lowell

Phone: 978-934-3965

Email: jiabin_shen@uml.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place