Immersive Virtual Reality for Visuo-motor Integration Skill Assessment

June 9, 2023 updated by: Northeastern University

Immersive Virtual Reality for Visuo-motor Integration Skill Assessment in Children With Hemiplegia

A significant deficit affecting nearly half of children with hemiplegia is visual-motor integration, or eye-hand coordination. Children have difficulties integrating visual and motor information to effectively plan and execute movements. Visual-motor impairments are detrimental because they affect accuracy of reaching and grasping, which are movements involved in feeding, writing, and sports participation, among many other daily life activities. Although paper-and-pencil and touchscreen computer assessments exist, these fail to evaluate impairments under realistic, 3D conditions. This assessment barrier leads to significant gaps in knowledge the influence of these impairments on children's performance of functional activities.

We will use immersive virtual reality (VR) delivered using a head-mounted display (HMD) to address this gap. Because it is fully visually immersive, VR makes interactions similar to real world performance. These features enable HMD-VR to offer more natural assessment conditions. HMD-VR may help us gain important new knowledge about functional movement deficits in children with hemiplegia.

The purpose of this study is to evaluate low-cost HMD-VR as a realistic assessment tool for visual-motor integration deficits in children with hemiplegia. The long-term goals of our research program are to: 1) Inform clinical decision-making practices by providing families and clinicians with precise, accurate information about children's abilities; and 2) Generate new knowledge about visual-motor integration impairments to enhance the effectiveness of both virtual and conventional rehabilitation interventions. We will recruit 40 children with hemiplegia aged 7-16 years at GMFCS Levels I-III and Manual Ability Classification System levels I-II for testing sessions of seated paper-and-pencil, touchscreen computer and HMD-VR visual-motor integration tasks at 3 clinical sites We will measure feasibility using counts of enrollment, side-effects and protocol completion. Visual-motor integration is quantified in the paper-and-pencil task via standardized score and in touchscreen and HMD-VR tasks using equivalent temporal and spatial eye and hand metrics. This pilot study will generate descriptive estimates of differences in visual-motor performance under conditions of differing 3D realism. This work is the first step towards the ultimate goal of a valid assessment method informing new VR-based treatment options for children with hemiplegia.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In a private testing room at the testing site, children will complete descriptive functional sensory-motor tests with a registered physical therapist. They will then complete the paper-and-pencil visual-motor integration test (Beery-Buktenica Test of Visual Motor Integration) while seated comfortably. They will then undertake the visuomotor integration tasks using a touch screen computer, completing 5 trials of each of 3 target positions under visual-only, motor-only, and visual-motor integration conditions. The task will be displayed on a 20" HP Spectre touch-screen laptop with an RTX 960 graphics card. Eye-tracking will be undertaken using a Tobii Nano which integrates with Unity software. Kinematics of hand movement during reach to touch as well as head movements will be collected using an Orbbec Astra depth-sensing camera. Accuracy of touch is recorded by custom-written software tracking X-Y touch coordinates on the screen. All data collection modalities are synced and integrated using LabVIEW.

Children will then complete the same tasks in the 3D HMD virtual environment. We will use the VIVE Pro EYE, the leading commercially-available immersive VR system, which has with a 110 degree trackable field of view and an embedded eye tracker. Arm movements are tracked by lightweight trackers attached via Velcro arm band to children's forearms and ManusVR motion tracking gloves worn on the hands. Head movements are tracked by position sensors in the HMD. Trackers and gloves enable upper extremity interaction with objects in the virtual world. An Alienware m15 gaming laptop with an NVIDA GeForce RTX 2060 graphics card will run the task. Following the visual-only, motor-only, and visual-motor integration tasks, children will complete a new visual-motor integration task involving virtual object transport, where they will grasp a virtual object and transport it to a new location in the virtual environment. Finally, they will complete the object transport task in a more audiovisually-complex virtual environment in the HMD.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maine
      • Portland, Maine, United States, 04074
        • Maine Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Salem, Massachusetts, United States, 01970
        • Spaulding Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Study Population

Cerebral Palsy (CP) has an estimated incidence of 3.1-3.6 per 1000 8-year-old children in the US. One third of children with CP have hemiplegia. Hemiplegia causes unilateral upper extremity sensorimotor deficits that impact everyday activities such as pointing, reaching, grasping, and releasing objects of interest, eating with utensils, printing, drawing, buttoning shirts, and other self-care tasks. These impairments limit independent performance in daily life activities and impact quality of life.

Description

Inclusion Criteria:

  • Diagnosis of hemiplegia (due to CP or stroke)
  • Gross Motor Function Classification System (GMFCS) Levels I-III
  • Manual Ability Classification System (MACS) Levels I-II
  • Ability to read and write English.
  • Sufficient hearing, vision and cognition to respond to auditory and visual cues.

Exclusion Criteria:

  • Greater than 10-degree elbow or shoulder flexion contracture in the affected arm
  • Uncorrected visual deficits (e.g., homonymous hemianopsia, oculomotor disturbance, or cortical visual impairment)
  • Uncontrolled photosensitive seizures (occurrence of at least one seizure in the last 3 months)
  • Hemineglect
  • Cognitive impairments that would prohibit participation (as judged by a parent)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Immersive virtual reality visuo-motor skill assessment
Visuo-motor skill assessment in an immersive 3D virtual environment using a head-mounted display.
Experimental: Typically developing children
40 typically developing children, 7-16 years-old.
Device: Immersive virtual reality visuo-motor skill assessment
Visuo-motor skill assessment in an immersive 3D virtual environment using a head-mounted display.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eye-hand Proximity
Time Frame: During testing.
Lag between eye end time and hand end time (i.e. eye movement time - hand movement time)
During testing.
Beery-Buktenica VMI Test 6th Edition (Short Form)
Time Frame: Pre-testing.

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.
Pre-testing.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and Blocks
Time Frame: Pre-testing
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.
Pre-testing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northeastern University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Massachusetts General Hospital
Spaulding Rehabilitation Hospital
MaineHealth

Investigators

  • Principal Investigator: Danielle Levac, PhD, Northeastern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

October 27, 2020

First Posted (Actual)

November 2, 2020

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 412575-19357
  • P2CHD101912 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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