NCT06320106

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Feb 2023Dec 2026

Study Start

First participant enrolled

February 7, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

3.9 years

First QC Date

March 13, 2024

Last Update Submit

February 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Learning rate

    One day

  • Simulator Sickness Questionnaire

    One day

  • System Usability Scale

    One day

  • Independent Television Commission-Sense of Presence Inventory

    One day

  • Suitability Evaluation Questionnaire - simplified version

    One day

  • +1 more secondary outcomes

Study Arms (2)

CP group

EXPERIMENTAL

Participants with cerebral palsy are recruited.

Other: Virtual Reality baseline assessment

TD group

EXPERIMENTAL

Typically developing children are recruited.

Other: Virtual Reality baseline assessment

Interventions

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.

CP groupTD group

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • IQ higher than 70

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scientific Institute, IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 20, 2024

Study Start

February 7, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 26, 2025

Record last verified: 2025-02

Locations