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Recruiting NCT06320106

Assessment of Navigation Abilities in Children With Cerebral Palsy and Their Peers

No phase Interventional Cerebral Palsy Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality baseline assessment.
Who it may be relevant to
Registry conditions: Cerebral Palsy, Healthy Volunteers. Basic parameters: from 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Spatial Navigation Skills in Typically Developing Children and in Children With Cerebral Palsy Using a Head Mounted Display

Overview

Spatial navigation skills are very important in everyday activities and quality of life but spatial navigation abilities are not part of the standard process of assessment and rehabilitation of patients. Furthermore, it is known that children with cerebral palsy have impaired visuo-spatial competences. The main objective of this study is to evaluate and compare the spatial navigation abilities of typically developing children and of children with cerebral palsy using the "StarMaze" application delivered by means of a Head Mounted Display (HMD). The second aim is to investigate the user experience during the session. A similar application was already developed and tested in a virtual reality large scale platform whose size and cost limit the accessibility. Therefore, the assessment (and future training) of navigation abilities with affordable and easy-to-use technology such as HMD open new perspectives.

Interventions

  • Other Virtual Reality baseline assessment
    They undergo a baseline assessment (including cognitive level and pen and paper tests for visuo-spatial abilities). Then they perform a spatial navigation assessment with an immersive virtual reality application delivered by the Oculus Quest viewer. The spatial navigation application consists of a 5-way star-maze adapted from (Biffi et al 2020 Front. Psychol.) where the participants have to find a treasure hidden at the end of one way. The application measures both the learning of spatial inform

Primary outcome measures

  • Navigation strategy [Time frame: One day]
Secondary outcome measures (6)
  • Learning rate [Time frame: One day]
  • Simulator Sickness Questionnaire [Time frame: One day]
  • System Usability Scale [Time frame: One day]
  • Independent Television Commission-Sense of Presence Inventory [Time frame: One day]
  • Suitability Evaluation Questionnaire - simplified version [Time frame: One day]
  • Short-form of PANAS-Positive Affect and Negative Affect Scales [Time frame: One day]

Eligibility criteria

Inclusion criteria

  • IQ higher than 70

Exclusion criteria

  • Subjects with epileptic issues
  • Subjects with poor head control
  • Visual acuity not correctable with eyeglasses

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Italy · 1 center
  • Scientific Institute, IRCCS E. Medea — Bosisio Parini

Identifiers

NCT: NCT06320106 · GIP 1021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗