Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:38 AM
Study NCT ID:
NCT06320106
Status:
RECRUITING
Last Update Posted:
2025-02-26
First Post:
2024-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Navigation Abilities in Children With Cerebral Palsy and Their Peers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Navigation strategy', 'timeFrame': 'One day', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Learning rate', 'timeFrame': 'One day', 'description': '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'}, {'measure': 'Simulator Sickness Questionnaire', 'timeFrame': 'One day', 'description': '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.'}, {'measure': 'System Usability Scale', 'timeFrame': 'One day', 'description': '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.'}, {'measure': 'Independent Television Commission-Sense of Presence Inventory', 'timeFrame': 'One day', 'description': '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).'}, {'measure': 'Suitability Evaluation Questionnaire - simplified version', 'timeFrame': 'One day', 'description': 'It evaluates the sense of agency with four questions (likert scale 1-5) and one open question.'}, {'measure': 'Short-form of PANAS-Positive Affect and Negative Affect Scales', 'timeFrame': 'One day', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy', 'Healthy Volunteers']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IQ higher than 70\n\nExclusion Criteria:\n\n* Subjects with epileptic issues\n* Subjects with poor head control\n* Visual acuity not correctable with eyeglasses'}, 'identificationModule': {'nctId': 'NCT06320106', 'briefTitle': 'Assessment of Navigation Abilities in Children With Cerebral Palsy and Their Peers', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Eugenio Medea'}, 'officialTitle': 'Evaluation of Spatial Navigation Skills in Typically Developing Children and in Children With Cerebral Palsy Using a Head Mounted Display', 'orgStudyIdInfo': {'id': 'GIP 1021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CP group', 'description': 'Participants with cerebral palsy are recruited.', 'interventionNames': ['Other: Virtual Reality baseline assessment']}, {'type': 'EXPERIMENTAL', 'label': 'TD group', 'description': 'Typically developing children are recruited.', 'interventionNames': ['Other: Virtual Reality baseline assessment']}], 'interventions': [{'name': 'Virtual Reality baseline assessment', 'type': 'OTHER', 'description': '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).\n\nAfter the session, the participants fill questionnaires related to cyber-sickness and usability of the application.', 'armGroupLabels': ['CP group', 'TD group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23842', 'city': 'Bosisio Parini', 'state': 'Lecco', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Emilia Biffi, PhD', 'role': 'CONTACT', 'email': 'emilia.biffi@lanostrafamiglia.it', 'phone': '+39 31877862'}, {'name': 'Emilia Biffi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Scientific Institute, IRCCS E. Medea', 'geoPoint': {'lat': 45.80075, 'lon': 9.29}}], 'centralContacts': [{'name': 'Emilia Biffi, PhD', 'role': 'CONTACT', 'email': 'emilia.biffi@lanostrafamiglia.it', 'phone': '0039 031877862'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Eugenio Medea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}