Trial Outcomes & Findings for Immersive Virtual Reality for Visuo-motor Integration Skill Assessment (NCT NCT04612049)

NCT ID: NCT04612049

Last Updated: 2023-06-12

Results Overview

Lag between eye end time and hand end time (i.e. eye movement time - hand movement time)

Recruitment status

TERMINATED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

During testing.

Results posted on

2023-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	Children With Hemiplegia 40 children with hemiplegia, 7-16 years-old at Gross Motor Function Classification System (GMFCS) Levels I-III and Manual Ability Classification System (MACS) Levels I-II will be recruited as participants. This age range was chosen based on our preliminary research in which children under the age of 7 had difficulty attending to repetitive task practice. Individuals will be recruited without regard to race or ethnicity. Our goal is to have a study sample that is 50% male and 50% female, and approximates the population of the Greater Boston, MA region. Immersive virtual reality visuo-motor skill assessment: Visuo-motor skill assessment in an immersive 3D virtual environment using a head-mounted display.	Typically Developing Children 40 typically developing children, 7-16 years-old. Immersive virtual reality visuo-motor skill assessment: Visuo-motor skill assessment in an immersive 3D virtual environment using a head-mounted display.
Overall Study STARTED	12	0
Overall Study COMPLETED	12	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immersive Virtual Reality for Visuo-motor Integration Skill Assessment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Children With Hemiplegia n=12 Participants 40 children with hemiplegia, 7-16 years-old at Gross Motor Function Classification System (GMFCS) Levels I-III and Manual Ability Classification System (MACS) Levels I-II will be recruited as participants. This age range was chosen based on our preliminary research in which children under the age of 7 had difficulty attending to repetitive task practice. Individuals will be recruited without regard to race or ethnicity. Our goal is to have a study sample that is 50% male and 50% female, and approximates the population of the Greater Boston, MA region. Immersive virtual reality visuo-motor skill assessment: Visuo-motor skill assessment in an immersive 3D virtual environment using a head-mounted display.	Typically Developing Children 40 typically developing children, 7-16 years-old. Immersive virtual reality visuo-motor skill assessment: Visuo-motor skill assessment in an immersive 3D virtual environment using a head-mounted display.	Total n=12 Participants Total of all reporting groups
Age, Continuous	10.25 years STANDARD_DEVIATION 2.84 • n=5 Participants	—	10.25 years STANDARD_DEVIATION 2.84 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	—	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	—	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: During testing.

Population: Unfortunately our kinematics plan for the 2D task did not enable collection of this outcome measure in the computerized 2D environment and as such we do not report it here for either 2D or immersive 3D.

Lag between eye end time and hand end time (i.e. eye movement time - hand movement time)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Pre-testing.

Population: No typically developing children were included in the study.

The Beery-Bukentica VMI, which is the unabbreviated scale title, is a test of visual-motor integration skills involving geometric design copying tasks. The administration time is 10-15 minutes. Children copy a series of increasingly complex designs using their preferred hand. We used the standard score, which ranges from 0 (minimum) to 100 (maximum). Higher scores indicate better VMI skills.

Outcome measures

Outcome measures
Measure	Children With Hemiplegia n=12 Participants 40 children with hemiplegia, 7-16 years-old at Gross Motor Function Classification System (GMFCS) Levels I-III and Manual Ability Classification System (MACS) Levels I-II will be recruited as participants. This age range was chosen based on our preliminary research in which children under the age of 7 had difficulty attending to repetitive task practice. Individuals will be recruited without regard to race or ethnicity. Our goal is to have a study sample that is 50% male and 50% female, and approximates the population of the Greater Boston, MA region. Immersive virtual reality visuo-motor skill assessment: Visuo-motor skill assessment in an immersive 3D virtual environment using a head-mounted display.	Typically Developing Children 40 typically developing children, 7-16 years-old. Immersive virtual reality visuo-motor skill assessment: Visuo-motor skill assessment in an immersive 3D virtual environment using a head-mounted display.
Beery-Buktenica VMI Test 6th Edition (Short Form)	83.64 score on a scale Standard Deviation 21.97	—

SECONDARY outcome

Timeframe: Pre-testing

Population: No typically developing children took part in the study.

he Box and Block Test (BBT) measures unilateral gross manual dexterity. Participants pick up blocks on one side of a wooden box and transport them to the other side, one at a time. The number of blocks successfully transported in one minute is scored. If a block falls or 2 blocks are picked up, it is not counted in the total. The minimum is zero. The maximum number of blocks is 150. A higher number of blocks indicates better gross manual dexterity, otherwise known as fine motor skills.

Outcome measures

Outcome measures
Measure	Children With Hemiplegia n=12 Participants 40 children with hemiplegia, 7-16 years-old at Gross Motor Function Classification System (GMFCS) Levels I-III and Manual Ability Classification System (MACS) Levels I-II will be recruited as participants. This age range was chosen based on our preliminary research in which children under the age of 7 had difficulty attending to repetitive task practice. Individuals will be recruited without regard to race or ethnicity. Our goal is to have a study sample that is 50% male and 50% female, and approximates the population of the Greater Boston, MA region. Immersive virtual reality visuo-motor skill assessment: Visuo-motor skill assessment in an immersive 3D virtual environment using a head-mounted display.	Typically Developing Children 40 typically developing children, 7-16 years-old. Immersive virtual reality visuo-motor skill assessment: Visuo-motor skill assessment in an immersive 3D virtual environment using a head-mounted display.
Box and Blocks	19.75 Number of blocks transported Standard Deviation 16.21	—

Adverse Events

Children With Hemiplegia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Typically Developing Children

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

Dr Danielle Levac

University of Montreal

Phone: 5148639108

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place