Study of Navigation Skills in Cerebral Palsy for Assessment and Rehabilitation in Immersive Virtual Reality
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Orientation
walking
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:.
- diagnosis of bilateral CP;
- age between 8 and 14 years old;
- severity of motor impairment classified in levels I, II and III, according to the Gross Motor Function Classification System (GMFCS) (Palisano et al., 1997)
- or according to the Manual Ability Classification System (MACS) (Eliasson et al., 2006);
- ability to follow instructions.
Exclusion Criteria:
- severe muscle spasticity and/or contracture,
- a diagnosis of severe learning disability,
- behavioral problems,
- visual or hearing difficulties that would affect the feasibility of proposed activities and/or compliance
Sites / Locations
- IRCCS Medea
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
orientation
walking
Arm Description
Orientation training with GRAIL
Walking training with GRAIL
Outcomes
Primary Outcome Measures
The Corsi Block Test
The Corsi Block Test (Orsini et al., 1987) assesses visuospatial memory and consists of a set of identical wooden blocks arranged more or less haphazardly on a desktop. The tester taps on a number of blocks in sequence, and the participant is asked to reproduce the tapped sequence, which is of variable length
The Labyrinth subtest of the WISC-III
The Labyrinth subtest of the WISC-III (Wechsler Intelligence Scale for Children, third version) consists of 10 paper-and-pencil tasks with increasing complexity (Weschler, 1991). The participant has to find the way out from the center of a 2-dimensional maze; it measures planning ability, perceptual organization, visualmotor coordination, and self-control
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04270305
Brief Title
Study of Navigation Skills in Cerebral Palsy for Assessment and Rehabilitation in Immersive Virtual Reality
Official Title
Study of Navigation Skills in Cerebral Palsy for Assessment and Rehabilitation in Immersive Virtual Reality
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 9, 2016 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Eugenio Medea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Spatial navigation refers to the ability to maintain a sense of direction/location while moving around the environment so to find one's way. It includes abilities such as orienting in complex environments,perceiving distance and planning routes to distant locations as well as mentally representing the reciprocal relations of landmarks in space (Lawton, 2010; Wolbers & Hegarty 2010. Spatial navigation involves the precision in encoding multisensorial (visual, vestibular, proprioceptive)experiences, as well as to form mental representations to be used to guide behavior (Bianchini et al.,2014).
Cerebral Palsy (CP) is a neurodevelopmental disorder characterized by movement and posture disorders causing activity limitation. Impairment in many other functions is common in CP including visual spatial competences and spatial organization. In this study the investigators meant to explore the navigation and learning strategies in children with CP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
orientation
Arm Type
Experimental
Arm Description
Orientation training with GRAIL
Arm Title
walking
Arm Type
Active Comparator
Arm Description
Walking training with GRAIL
Intervention Type
Other
Intervention Name(s)
Orientation
Intervention Description
In the first group CP patients undergo a four week training with once daily sessions lasting 30 minutes. The treatment includes exercises to improve navigation competences and orientation. During walk in VR environment with labyrinths of increasing complexity. Exercises include abilities such as orienting in complex environments, perceiving distance and planning routes to distant locations. The presence of landmarks has been included in some exercises to facilitate allocentric orientation strategies.
Intervention Type
Other
Intervention Name(s)
walking
Intervention Description
In the second group CP patients undergo a four week training with once daily sessions lasting 30 minutes. The treatment includes exercises to improve walking and balance abilities. Using engaging VR environments (e.g. transfer your load from the left to the right side to avoid obstacles while skiing; shoot balls at targets inside an area; walk in a forest as fast as possible; hit as many elves as possible by squatting, and so on). No exercises for orientation are included in this group.
Primary Outcome Measure Information:
Title
The Corsi Block Test
Description
The Corsi Block Test (Orsini et al., 1987) assesses visuospatial memory and consists of a set of identical wooden blocks arranged more or less haphazardly on a desktop. The tester taps on a number of blocks in sequence, and the participant is asked to reproduce the tapped sequence, which is of variable length
Time Frame
1 month
Title
The Labyrinth subtest of the WISC-III
Description
The Labyrinth subtest of the WISC-III (Wechsler Intelligence Scale for Children, third version) consists of 10 paper-and-pencil tasks with increasing complexity (Weschler, 1991). The participant has to find the way out from the center of a 2-dimensional maze; it measures planning ability, perceptual organization, visualmotor coordination, and self-control
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:.
diagnosis of bilateral CP;
age between 8 and 14 years old;
severity of motor impairment classified in levels I, II and III, according to the Gross Motor Function Classification System (GMFCS) (Palisano et al., 1997)
or according to the Manual Ability Classification System (MACS) (Eliasson et al., 2006);
ability to follow instructions.
Exclusion Criteria:
severe muscle spasticity and/or contracture,
a diagnosis of severe learning disability,
behavioral problems,
visual or hearing difficulties that would affect the feasibility of proposed activities and/or compliance
Facility Information:
Facility Name
IRCCS Medea
City
Bosisio Parini
State/Province
LC
ZIP/Postal Code
23842
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Navigation Skills in Cerebral Palsy for Assessment and Rehabilitation in Immersive Virtual Reality
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