Immersive Virtual Reality for Visuo-motor Integration Skill Assessment

NCT ID: NCT04612049

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2021-12-30

Brief Summary

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.

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.

Conditions

Cerebral Palsy; Hemiplegia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Immersive virtual reality visuo-motor skill assessment

Intervention Type: DEVICE

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.

Group Type: EXPERIMENTAL

Immersive virtual reality visuo-motor skill assessment

Intervention Type: DEVICE

Visuo-motor skill assessment in an immersive 3D virtual environment using a head-mounted display.

Interventions

Immersive virtual reality visuo-motor skill assessment

Visuo-motor skill assessment in an immersive 3D virtual environment using a head-mounted display.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MaineHealth

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Northeastern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle Levac, PhD

Role: PRINCIPAL_INVESTIGATOR

Northeastern University

Locations

Maine Health

Portland, Maine, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Spaulding Rehabilitation

Salem, Massachusetts, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P2CHD101912

Identifier Type: NIH

Identifier Source: secondary_id

View Link

412575-19357

Identifier Type: -

Identifier Source: org_study_id