Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-01-07 @ 12:49 PM
Study NCT ID:
NCT04460833
Status:
COMPLETED
Last Update Posted:
2022-06-23
First Post:
2020-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feedback in Augmented Reality to Control of Gait Parameters in Children With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}], '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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Feedback modalities are given through an augmented reality headset by random'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-22', 'studyFirstSubmitDate': '2020-03-12', 'studyFirstSubmitQcDate': '2020-07-02', 'lastUpdatePostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'walking speed', 'timeFrame': '1 year', 'description': 'Walking speed recorded with the augmented reality headset in real-time'}, {'measure': 'step length', 'timeFrame': '1 year', 'description': 'step length recorded with the augmented reality headset in real-time'}], 'secondaryOutcomes': [{'measure': 'Moizer Questionary', 'timeFrame': '1 year', 'description': 'User experience survey; 25 items scored 1 for "I perfectly agree" to 5 "I completly disagree" this item; max score = 25; min score = 125'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Serious Game', 'Rehabilitation'], 'conditions': ['Cerebral Palsy', 'Gait Disorders, Neurologic', 'Feedback, Psychological']}, 'referencesModule': {'references': [{'pmid': '35951576', 'type': 'DERIVED', 'citation': 'Guinet AL, Bouyer G, Otmane S, Desailly E. Visual Feedback in Augmented Reality to Walk at Predefined Speed Cross-Sectional Study Including Children With Cerebral Palsy. IEEE Trans Neural Syst Rehabil Eng. 2022;30:2322-2331. doi: 10.1109/TNSRE.2022.3198243. Epub 2022 Aug 22.'}], 'seeAlsoLinks': [{'url': 'https://www.fondationpoidatz.com/', 'label': 'Website of the EllenPoidatz Foundation (See Research and Innovation)'}]}, 'descriptionModule': {'briefSummary': 'Cerebral palsy (CP) describes a group of permanent disorders of the development of movement and posture, causing activity limitation, that are attributed to non progressive disturbances that occurred in the developing fetal or infant brain. The motor disorder of CP are often accompanied by disturbances of sensation, perception, cognition, communication, and behaviour; by epilepsy, and by secondary musculoskeletal problems.\n\nMotor activities, especially walking, can be affected by many factors including sensory deficits, biomechanical and postural limitations, muscle weakness and spasticity.To provide feedback, during gait rehabilitation is a complementary approach to improve motor learning during the rehabilitation protocol. However, the feedback modalities are multiple and no study has compared these modalities. This study aims to test which feedback modalities could control the gait parameters (speed, cadence, step length) of the child with CP in real-time, through an augmented reality environment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with Cerebral palsy (medical file)\n* Age 12-18\n* Global Motor Function Classification System (GMFCS) I-III\n* Functional Mobility Scale (FMS) minimum 2 for "50 meters"\n* Ability to cooperate, to understand and to follow instructions\n* Patient affiliated to the French social security system\n* Patient volunteers whose the parents given their authorization to participate\n\nExclusion Criteria:\n\n* Medical decision for any reason\n* Child or parent decision for any reason\n* Inability to cooperate, to understand and to follow instructions'}, 'identificationModule': {'nctId': 'NCT04460833', 'acronym': 'BestOf_ARRoW', 'briefTitle': 'Feedback in Augmented Reality to Control of Gait Parameters in Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Ellen Poidatz'}, 'officialTitle': 'Feedback in Augmented Reality to Control the Gait Parameters in Children With Cerebral Palsy (BestOf_ARRoW)', 'orgStudyIdInfo': {'id': 'BestOf_ARRoW Feedback'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test group', 'description': 'All children will have the 6 feedback modalities + the control given randomly', 'interventionNames': ['Device: Feedback modalities given through an augmented reality headset']}], 'interventions': [{'name': 'Feedback modalities given through an augmented reality headset', 'type': 'DEVICE', 'description': 'All children wear the augmented reality headset. After a habituation period to the holograms, they start the protocol. It consists of a warm-up session, training session (which three feedback modalities are presented), calibration session (to get the maximal speed and spontaneous speed of the child), and test session. During test session, all the children walk on the 30m corridor. They have 6 feedback modalities + the control, given randomly. On the way out, they have to walk fast as possible ; on the return they have to walk at intermediate speed.', 'armGroupLabels': ['Test group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77310', 'city': 'Saint-Fargeau-Ponthierry', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Fondation Ellen Poidatz', 'geoPoint': {'lat': 48.55713, 'lon': 2.5284}}], 'overallOfficials': [{'name': 'Eric DESAILLY, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Ellen Poidatz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ellen Poidatz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Paris-Sud', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}