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| ID | Type | Description | Link |
|---|---|---|---|
| P2CHD101912 | U.S. NIH Grant/Contract | View source |
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Investigator changed sites
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| Name | Class |
|---|---|
| MaineHealth | OTHER |
| Massachusetts General Hospital | OTHER |
| Spaulding Rehabilitation Hospital | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with hemiplegia | Experimental | 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. |
|
| Typically developing children | Experimental | 40 typically developing children, 7-16 years-old. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immersive virtual reality visuo-motor skill assessment | Device | Visuo-motor skill assessment in an immersive 3D virtual environment using a head-mounted display. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eye-hand Proximity | 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) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle Levac, PhD | Northeastern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maine Health | Portland | Maine | 04074 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17070630 | Background | Ronnqvist L, Rosblad B. Kinematic analysis of unimanual reaching and grasping movements in children with hemiplegic cerebral palsy. Clin Biomech (Bristol). 2007 Feb;22(2):165-75. doi: 10.1016/j.clinbiomech.2006.09.004. Epub 2006 Oct 27. | |
| 16442974 | Background | Mackey AH, Walt SE, Stott NS. Deficits in upper-limb task performance in children with hemiplegic cerebral palsy as defined by 3-dimensional kinematics. Arch Phys Med Rehabil. 2006 Feb;87(2):207-15. doi: 10.1016/j.apmr.2005.10.023. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study timeline due to investigator changing institutions limited collected data with typically developing children.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Eye-hand Proximity | Lag between eye end time and hand end time (i.e. eye movement time - hand movement time) | 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. | Posted | During testing. |
|
3 months
No differences
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Early termination due to Investigator changing sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Danielle Levac | University of Montreal | 5148639108 | danielle.levac@umontreal.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2020 | Jun 7, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 1, 2020 | Jun 7, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| NIH |
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| Pre-testing |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Spaulding Rehabilitation | Salem | Massachusetts | 01970 | United States |
| 27188686 | Background | Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82. |
| 19416339 | Background | Shevell MI, Dagenais L, Hall N; REPACQ CONSORTIUM*. The relationship of cerebral palsy subtype and functional motor impairment: a population-based study. Dev Med Child Neurol. 2009 Nov;51(11):872-7. doi: 10.1111/j.1469-8749.2009.03269.x. Epub 2009 Mar 11. |
| 25690117 | Background | Ego A, Lidzba K, Brovedani P, Belmonti V, Gonzalez-Monge S, Boudia B, Ritz A, Cans C. Visual-perceptual impairment in children with cerebral palsy: a systematic review. Dev Med Child Neurol. 2015 Apr;57 Suppl 2:46-51. doi: 10.1111/dmcn.12687. |
| 25703777 | Background | James S, Ziviani J, Ware RS, Boyd RN. Relationships between activities of daily living, upper limb function, and visual perception in children and adolescents with unilateral cerebral palsy. Dev Med Child Neurol. 2015 Sep;57(9):852-7. doi: 10.1111/dmcn.12715. Epub 2015 Feb 23. |
| 31608806 | Background | Mallory K, Barton K, Woodhouse J, Bernstein J, Greenspoon D, Reed N. Occupational Performance Issues of Children with Hemiplegia after Acquired Brain Injury. Phys Occup Ther Pediatr. 2020;40(3):279-293. doi: 10.1080/01942638.2019.1675845. Epub 2019 Oct 14. |
| 17370477 | Background | Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14. |
| 23346889 | Background | Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24. |
| 27323932 | Background | Chiu HC, Ada L. Constraint-induced movement therapy improves upper limb activity and participation in hemiplegic cerebral palsy: a systematic review. J Physiother. 2016 Jul;62(3):130-7. doi: 10.1016/j.jphys.2016.05.013. Epub 2016 Jun 17. |
| 30932166 | Background | Hoare BJ, Wallen MA, Thorley MN, Jackman ML, Carey LM, Imms C. Constraint-induced movement therapy in children with unilateral cerebral palsy. Cochrane Database Syst Rev. 2019 Apr 1;4(4):CD004149. doi: 10.1002/14651858.CD004149.pub3. |
| 28339410 | Background | Hoare B, Greaves S. Unimanual versus bimanual therapy in children with unilateral cerebral palsy: Same, same, but different. J Pediatr Rehabil Med. 2017;10(1):47-59. doi: 10.3233/PRM-170410. |
| 30557847 | Background | Krajenbrink H, Crichton A, Steenbergen B, Hoare B. The development of anticipatory action planning in children with unilateral cerebral palsy. Res Dev Disabil. 2019 Feb;85:163-171. doi: 10.1016/j.ridd.2018.12.002. Epub 2018 Dec 14. |
| 28035572 | Background | Gordon AM. Impaired Voluntary Movement Control and Its Rehabilitation in Cerebral Palsy. Adv Exp Med Biol. 2016;957:291-311. doi: 10.1007/978-3-319-47313-0_16. |
| 18830589 | Background | Saavedra S, Karve SJ, Woollacott M, van Donkelaar P. Eye hand coordination in children with cerebral palsy. Exp Brain Res. 2009 Jan;192(2):155-65. doi: 10.1007/s00221-008-1549-8. Epub 2008 Oct 2. |
| 29457030 | Background | Fang Y, Wang J, Zhang Y, Qin J. The Relationship of Motor Coordination, Visual Perception, and Executive Function to the Development of 4-6-Year-Old Chinese Preschoolers' Visual Motor Integration Skills. Biomed Res Int. 2017;2017:6264254. doi: 10.1155/2017/6264254. Epub 2017 Dec 31. |
| 18231781 | Background | Verrel J, Bekkering H, Steenbergen B. Eye-hand coordination during manual object transport with the affected and less affected hand in adolescents with hemiparetic cerebral palsy. Exp Brain Res. 2008 May;187(1):107-16. doi: 10.1007/s00221-008-1287-y. Epub 2008 Jan 30. |
| 28422801 | Background | Harvey EM, Leonard-Green TK, Mohan KM, Kulp MT, Davis AL, Miller JM, Twelker JD, Campus I, Dennis LK. Interrater and Test-Retest Reliability of the Beery Visual-Motor Integration in Schoolchildren. Optom Vis Sci. 2017 May;94(5):598-605. doi: 10.1097/OPX.0000000000001068. |
| 15679949 | Background | Weiss PL, Rand D, Katz N, Kizony R. Video capture virtual reality as a flexible and effective rehabilitation tool. J Neuroeng Rehabil. 2004 Dec 20;1(1):12. doi: 10.1186/1743-0003-1-12. |
| 31627755 | Background | Levac DE, Huber ME, Sternad D. Learning and transfer of complex motor skills in virtual reality: a perspective review. J Neuroeng Rehabil. 2019 Oct 18;16(1):121. doi: 10.1186/s12984-019-0587-8. |
| 28816511 | Background | Levac D, Glegg S, Colquhoun H, Miller P, Noubary F. Virtual Reality and Active Videogame-Based Practice, Learning Needs, and Preferences: A Cross-Canada Survey of Physical Therapists and Occupational Therapists. Games Health J. 2017 Aug;6(4):217-228. doi: 10.1089/g4h.2016.0089. |
| 8109566 | Background | Spodick DH. Accuracy of nongeometric pulsed Doppler cardiac output. Am J Cardiol. 1994 Feb 15;73(5):421. doi: 10.1016/0002-9149(94)90031-0. No abstract available. |
| 29427357 | Background | Robert MT, Levin MF. Validation of reaching in a virtual environment in typically developing children and children with mild unilateral cerebral palsy. Dev Med Child Neurol. 2018 Apr;60(4):382-390. doi: 10.1111/dmcn.13688. Epub 2018 Feb 10. |
| 24981192 | Background | de Mello Monteiro CB, Massetti T, da Silva TD, van der Kamp J, de Abreu LC, Leone C, Savelsbergh GJ. Transfer of motor learning from virtual to natural environments in individuals with cerebral palsy. Res Dev Disabil. 2014 Oct;35(10):2430-7. doi: 10.1016/j.ridd.2014.06.006. Epub 2014 Jun 28. |
| 19406299 | Background | Knaut LA, Subramanian SK, McFadyen BJ, Bourbonnais D, Levin MF. Kinematics of pointing movements made in a virtual versus a physical 3-dimensional environment in healthy and stroke subjects. Arch Phys Med Rehabil. 2009 May;90(5):793-802. doi: 10.1016/j.apmr.2008.10.030. |
| 21718542 | Background | Subramanian SK, Levin MF. Viewing medium affects arm motor performance in 3D virtual environments. J Neuroeng Rehabil. 2011 Jun 30;8:36. doi: 10.1186/1743-0003-8-36. |
| 28567271 | Background | Niehorster DC, Li L, Lappe M. The Accuracy and Precision of Position and Orientation Tracking in the HTC Vive Virtual Reality System for Scientific Research. Iperception. 2017 May 18;8(3):2041669517708205. doi: 10.1177/2041669517708205. eCollection 2017 May-Jun. |
| 30806663 | Background | Fears NE, Bailey BC, Youmans B, Lockman JJ. An Eye-Tracking Method for Directly Assessing Children's Visual-Motor Integration. Phys Ther. 2019 Jun 1;99(6):797-806. doi: 10.1093/ptj/pzz027. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 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. |
|
| Primary | 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. | No typically developing children were included in the study. | Posted | Mean | Standard Deviation | score on a scale | Pre-testing. |
|
|
|
| Secondary | 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. | No typically developing children took part in the study. | Posted | Mean | Standard Deviation | Number of blocks transported | Pre-testing |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |