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Immersive Virtual Reality for Visuo-motor Integration Skill Assessment

Primary Purpose

Cerebral Palsy, Hemiplegia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immersive virtual reality visuo-motor skill assessment
Sponsored by
Northeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Cerebral Palsy focused on measuring Virtual Reality, Visual-Motor Integration, Feasibility

Eligibility Criteria

7 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Maine Health
  • Massachusetts General Hospital
  • Spaulding Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Children with hemiplegia

Typically developing children

Arm Description

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.

40 typically developing children, 7-16 years-old.

Outcomes

Primary Outcome Measures

Eye-hand Proximity
Lag between eye end time and hand end time (i.e. eye movement time - hand movement time)
Beery-Buktenica VMI Test 6th Edition (Short Form)
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.

Secondary Outcome Measures

Box and Blocks
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.

Full Information

First Posted
October 27, 2020
Last Updated
June 9, 2023
Sponsor
Northeastern University
Collaborators
MaineHealth, Massachusetts General Hospital, Spaulding Rehabilitation Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04612049
Brief Title
Immersive Virtual Reality for Visuo-motor Integration Skill Assessment
Official Title
Immersive Virtual Reality for Visuo-motor Integration Skill Assessment in Children With Hemiplegia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Investigator changed sites
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northeastern University
Collaborators
MaineHealth, Massachusetts General Hospital, Spaulding Rehabilitation Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Hemiplegia
Keywords
Virtual Reality, Visual-Motor Integration, Feasibility

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children with hemiplegia
Arm Type
Experimental
Arm Description
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.
Arm Title
Typically developing children
Arm Type
Experimental
Arm Description
40 typically developing children, 7-16 years-old.
Intervention Type
Device
Intervention Name(s)
Immersive virtual reality visuo-motor skill assessment
Intervention Description
Visuo-motor skill assessment in an immersive 3D virtual environment using a head-mounted display.
Primary Outcome Measure Information:
Title
Eye-hand Proximity
Description
Lag between eye end time and hand end time (i.e. eye movement time - hand movement time)
Time Frame
During testing.
Title
Beery-Buktenica VMI Test 6th Edition (Short Form)
Description
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.
Time Frame
Pre-testing.
Secondary Outcome Measure Information:
Title
Box and Blocks
Description
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.
Time Frame
Pre-testing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Levac, PhD
Organizational Affiliation
Northeastern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maine Health
City
Portland
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Spaulding Rehabilitation
City
Salem
State/Province
Massachusetts
ZIP/Postal Code
01970
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Immersive Virtual Reality for Visuo-motor Integration Skill Assessment

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