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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06320106
• Other study ID #: GIP 1021
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2024
• Source: IRCCS Eugenio Medea
• Contact: Emilia Biffi, PhD
• Phone: 0039 031877862
• Email: emilia.biffi[@]lanostrafamiglia.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

• IQ higher than 70

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Healthy Volunteers

Intervention

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 information and the strategy used (egocentric or allocentric). After the session, the participants fill questionnaires related to cyber-sickness and usability of the application.

Locations

Country	Name	City	State
Italy	Scientific Institute, IRCCS E. Medea	Bosisio Parini	Lecco

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Navigation strategy	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.	One day
Secondary	Learning rate	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	One day
Secondary	Simulator Sickness Questionnaire	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.	One day
Secondary	System Usability Scale	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.	One day
Secondary	Independent Television Commission-Sense of Presence Inventory	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).	One day
Secondary	Suitability Evaluation Questionnaire - simplified version	It evaluates the sense of agency with four questions (likert scale 1-5) and one open question.	One day
Secondary	Short-form of PANAS-Positive Affect and Negative Affect Scales	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.	One day