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Completed

NCT Number: NCT04270305

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.

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Key information

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Medea

Bosisio Parini, LC, 23842, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orientation

Other

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.

walking

Other

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 outcomes

  1. The Corsi Block Test

    Time frame: 1 month

    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

  2. The Labyrinth subtest of the WISC-III

    Time frame: 1 month

    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

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2020
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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