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

NCT ID: NCT06320106

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-07

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CP group

Participants with cerebral palsy are recruited.

Group Type EXPERIMENTAL

Virtual Reality baseline assessment

Intervention Type OTHER

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.

TD group

Typically developing children are recruited.

Group Type EXPERIMENTAL

Virtual Reality baseline assessment

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* IQ higher than 70

Exclusion Criteria

* Subjects with epileptic issues
* Subjects with poor head control
* Visual acuity not correctable with eyeglasses
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

IRCCS Eugenio Medea

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Scientific Institute, IRCCS E. Medea

Bosisio Parini, Lecco, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Emilia Biffi, PhD

Role: CONTACT

0039 031877862

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Emilia Biffi, PhD

Role: primary

+39 31877862

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GIP 1021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.