Cerebral PalsyNCT06320106
Assessment of Navigation Abilities in Children With Cerebral Palsy and Their Peers
A study testing Virtual Reality baseline assessment in people with Cerebral Palsy and Healthy Volunteers, run by IRCCS Eugenio Medea at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Healthy Volunteers
- What is being tested?
- Virtual Reality baseline assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 7 Feb 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- IQ higher than 70
Who cannot join
- Subjects with epileptic issues
- Subjects with poor head control
- Visual acuity not correctable with eyeglasses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Scientific Institute, IRCCS E. Medea
Bosisio Parini, Lecco, 23842
Emilia Biffi, PhD, +39 31877862, emilia.biffi@lanostrafamiglia.it
Emilia Biffi, PhD
About this study
Official title: Evaluation of Spatial Navigation Skills in Typically Developing Children and in Children With Cerebral Palsy Using a Head Mounted Display
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.
- Conditions
- Cerebral Palsy, Healthy Volunteers
- Being tested
- Virtual Reality baseline assessment
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality baseline assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CP group | Experimental | Participants with cerebral palsy are recruited. Receives: Other: Virtual Reality baseline assessment |
| TD group | Experimental | Typically developing children are recruited. Receives: Other: Virtual Reality baseline assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day
Secondary outcomes (6)
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
Measured: One day
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.
Measured: One day
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.
Measured: One day
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).
Measured: One day
Suitability Evaluation Questionnaire - simplified version
It evaluates the sense of agency with four questions (likert scale 1-5) and one open question.
Measured: One day
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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start7 Feb 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320106
- Sponsor's protocol ID
- GIP 1021
- Status last verified
- Feb 2025
- First submitted
- 13 Mar 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Spatial Navigation Skills in Typically Developing Children and in Children With Cerebral Palsy Using a Head Mounted Display
- ClinicalTrials.gov ID
- NCT06320106
- Acronym / sponsor ID
- GIP 1021
- Conditions
- Cerebral Palsy, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CP group | Experimental | Other: Virtual Reality baseline assessmentParticipants with cerebral palsy are recruited. |
| TD group | Experimental | Other: Virtual Reality baseline assessmentTypically developing children are recruited. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- IQ higher than 70
Key exclusion criteria (3 listed)
- Subjects with epileptic issues
- Subjects with poor head control
- Visual acuity not correctable with eyeglasses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality baseline assessmentThey 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. | Other | CP group, TD group |
Primary outcome
Navigation strategy
Time frame: 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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality baseline assessment in people with Cerebral Palsy and Healthy Volunteers, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilia Biffi, PhD (0039 031877862, emilia.biffi@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Navigation strategy (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.