Study of Navigation Skills in Cerebral Palsy for Assessment and Rehabilitation in Immersive Virtual Reality

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Orientation; Other: walking

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • LC
    • Bosisio Parini, LC, Italy, 23842
      • IRCCS Medea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: orientation; Orientation training with GRAIL	Other: Orientation; 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.
Active Comparator: walking; Walking training with GRAIL	Other: walking; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month
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	1 month

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2016
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 308

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