Trial Outcomes & Findings for VR-based EF Rehabilitation for Pediatric TBI (NCT NCT03611062)

NCT ID: NCT03611062

Last Updated: 2021-09-14

Results Overview

Measured by the Simulator Sickness Questionnaire. Total scores range from 0 to 26, with 0 representing a better outcome of less sickness.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: Post-Intervention, up to 30 minutes after intervention
• Results posted on: 2021-09-14

Participant Flow

Participant milestones

Measure	VR Executive Functions Training Participants will receive training of executive functions in a virtual reality environment. VR Executive Functions Training: The Windows 10-based VICT program invites children to rescue an animated character named "Lubdub" from a castle. The program consists of three challenging and child-friendly tasks that correspond to the three core EFs.	Control Participants will play a virtual reality game using the same hardware and similar environments, but without the training of executive functions. VR Placebo Game: In this game, children in the control group will use the VR hand controller to cast different types of spells (bees, bouncy balls, sparkler spells) to objects in the virtual world. Objects in the VR world will all react differently to a spell being cast so as to provide children a relaxing and EF-free gaming experience.
Overall Study STARTED	14	13
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

VR-based EF Rehabilitation for Pediatric TBI

Baseline characteristics by cohort

Measure	VR Executive Functions Training n=13 Participants Participants will receive training of executive functions in a virtual reality environment. VR Executive Functions Training: The Windows 10-based VICT program invites children to rescue an animated character named "Lubdub" from a castle. The program consists of three challenging and child-friendly tasks that correspond to the three core EFs.	Control n=12 Participants Participants will play a virtual reality game using the same hardware and similar environments, but without the training of executive functions. VR Placebo Game: In this game, children in the control group will use the VR hand controller to cast different types of spells (bees, bouncy balls, sparkler spells) to objects in the virtual world. Objects in the VR world will all react differently to a spell being cast so as to provide children a relaxing and EF-free gaming experience.	Total n=25 Participants Total of all reporting groups
Age, Continuous	13.77 years STANDARD_DEVIATION 3.09 • n=5 Participants	11.75 years STANDARD_DEVIATION 3.17 • n=7 Participants	12.80 years STANDARD_DEVIATION 3.23 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Post-Intervention, up to 30 minutes after intervention

Measured by the Simulator Sickness Questionnaire. Total scores range from 0 to 26, with 0 representing a better outcome of less sickness.

Outcome measures

Measure	VR Executive Functions Training n=13 Participants Participants will receive training of executive functions in a virtual reality environment. VR Executive Functions Training: The Windows 10-based VICT program invites children to rescue an animated character named "Lubdub" from a castle. The program consists of three challenging and child-friendly tasks that correspond to the three core EFs.	Control n=12 Participants Participants will play a virtual reality game using the same hardware and similar environments, but without the training of executive functions. VR Placebo Game: In this game, children in the control group will use the VR hand controller to cast different types of spells (bees, bouncy balls, sparkler spells) to objects in the virtual world. Objects in the VR world will all react differently to a spell being cast so as to provide children a relaxing and EF-free gaming experience.
Level of Simulator Sickness [Feasibility and Safety]	0.16 score on a scale Standard Deviation 0.19	0.03 score on a scale Standard Deviation 0.04

PRIMARY outcome

Timeframe: Post-Intervention, up to 30 minutes after intervention

Measured by the Borg Rating of Perceived Exertion Scale. Total score ranges from 6 to 20, with 6 being a lower amount of exertion.

Outcome measures

Measure	VR Executive Functions Training n=13 Participants Participants will receive training of executive functions in a virtual reality environment. VR Executive Functions Training: The Windows 10-based VICT program invites children to rescue an animated character named "Lubdub" from a castle. The program consists of three challenging and child-friendly tasks that correspond to the three core EFs.	Control n=12 Participants Participants will play a virtual reality game using the same hardware and similar environments, but without the training of executive functions. VR Placebo Game: In this game, children in the control group will use the VR hand controller to cast different types of spells (bees, bouncy balls, sparkler spells) to objects in the virtual world. Objects in the VR world will all react differently to a spell being cast so as to provide children a relaxing and EF-free gaming experience.
Level of Physical Fatigability [Feasibility and Safety]	6.25 score on a scale Standard Deviation 0.50	11.50 score on a scale Standard Deviation 2.12

PRIMARY outcome

Timeframe: Post-Intervention, up to 30 minutes after intervention

Measured by asking participants to respond to the following question: How much did you like the VR games you just played? Measured on a scale 1-5, with higher values indicating greater enjoyment

Outcome measures

Measure	VR Executive Functions Training n=13 Participants Participants will receive training of executive functions in a virtual reality environment. VR Executive Functions Training: The Windows 10-based VICT program invites children to rescue an animated character named "Lubdub" from a castle. The program consists of three challenging and child-friendly tasks that correspond to the three core EFs.	Control n=12 Participants Participants will play a virtual reality game using the same hardware and similar environments, but without the training of executive functions. VR Placebo Game: In this game, children in the control group will use the VR hand controller to cast different types of spells (bees, bouncy balls, sparkler spells) to objects in the virtual world. Objects in the VR world will all react differently to a spell being cast so as to provide children a relaxing and EF-free gaming experience.
Perceived Virtual Reality Experience [Feasibility]	3.75 units on a scale Standard Deviation 0.96	4 units on a scale Standard Deviation 0

Adverse Events

VR Executive Functions Training

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	VR Executive Functions Training n=13 participants at risk Participants will receive training of executive functions in a virtual reality environment. VR Executive Functions Training: The Windows 10-based VICT program invites children to rescue an animated character named "Lubdub" from a castle. The program consists of three challenging and child-friendly tasks that correspond to the three core EFs.	Control n=12 participants at risk Participants will play a virtual reality game using the same hardware and similar environments, but without the training of executive functions. VR Placebo Game: In this game, children in the control group will use the VR hand controller to cast different types of spells (bees, bouncy balls, sparkler spells) to objects in the virtual world. Objects in the VR world will all react differently to a spell being cast so as to provide children a relaxing and EF-free gaming experience.
Eye disorders Blurry vision / eye strain	0.00% 0/13 • During the course of the study participation (up to 30 minutes after study completion)	8.3% 1/12 • Number of events 1 • During the course of the study participation (up to 30 minutes after study completion)
General disorders Headache	7.7% 1/13 • Number of events 1 • During the course of the study participation (up to 30 minutes after study completion)	0.00% 0/12 • During the course of the study participation (up to 30 minutes after study completion)

Additional Information

Dr. 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