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

Not Applicable

Recruiting

• Conditions: Healthy Volunteers; Cerebral Palsy
• Interventions: Other: Virtual Reality baseline assessment

• Registration Number: NCT06320106
• Lead Sponsor: IRCCS Eugenio Medea

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-07
• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• IQ higher than 70

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TD group	Virtual Reality baseline assessment	Typically developing children are recruited.
CP group	Virtual Reality baseline assessment	Participants with cerebral palsy are recruited.

Primary Outcome Measures

Name	Time	Method
Navigation strategy	One day	The navigation strategy is measured by the application "StarMaze" delivered by the Oculus Quest viewer and it could be egocentric or allocentric. The strategy is egocentric if the participant finds the treasure in the virtual space by using a self-centred trajectory. The strategy is allocentric if the participant find the treasure in the virtual space by using a trajectory based on environmental cues.

Secondary Outcome Measures

Name	Time	Method
Simulator Sickness Questionnaire	One day	The questionnaire evaluates the effects of cyber sickness. Participants have to score 16 symptoms on a four-point scale (0-3).The symptoms can be placed into three general categories: oculomotor, disorientation, and nausea. Weights are assigned to each of the categories and summed together to obtain a single score.
Independent Television Commission-Sense of Presence Inventory	One day	It is a 5-point Likert scale, composed of 44 items. This questionnaire evaluates the user experience to understand if the person enjoyed the game, the setting, and the overall experience. In particular, the questionnaire addresses four factors: spatial presence, engagement, realness of the environment, and side effects (cyber sickness).
Learning rate	One day	The learning rate of correct path to follow to find the treasure strategy is measured by the application "StarMaze" delivered by the Oculus Quest viewer. It is the number of trials required by the participant to reach a stable performance
Short-form of PANAS-Positive Affect and Negative Affect Scales	One day	In the questionnaire, the participant must evaluate how much s/he feels in the way described by the adjective when filling out the questionnaire, responding on a 5-point Likert scale. The PANAS provides measures of Positive Affects (PAs) and Negative Affects (NAs). The PA and NA scores are the sums of the ratings of the PA items and the NA items, respectively. PA indicates the level of pleasurable engagement with the product while NA is a general factor of subjective distress.
System Usability Scale	One day	It evaluates the usability of the system. The SUS is a simple, ten-item five-point Likert scale giving a global view of subjective assessments of usability.
Suitability Evaluation Questionnaire - simplified version	One day	It evaluates the sense of agency with four questions (likert scale 1-5) and one open question.

Trial Locations

Locations (1)

Scientific Institute, IRCCS E. Medea; 🇮🇹 Bosisio Parini, Lecco, Italy