Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT06516120
Status:
RECRUITING
Last Update Posted:
2024-07-23
First Post:
2024-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kinematics of Movements Provoked by an Augmented Reality App
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-03-06', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average movement velocity', 'timeFrame': 'Measured when using the RGS-app during the one-time measurement of 1.5 hours', 'description': 'Average velocity of every 2-minute session. Velocity is measured at the hand relative to the sternum.'}], 'secondaryOutcomes': [{'measure': 'Elbow mean angular velocity', 'timeFrame': 'Measured when using the RGS-app during the one-time measurement of 1.5 hours', 'description': 'Mean angular velocity in m/s of the elbow joint'}, {'measure': 'Pelvis mean angular velocity', 'timeFrame': 'Measured when using the RGS-app during the one-time measurement of 1.5 hours', 'description': 'Mean angular velocity will be calculated in m/s of the pelvis joint'}, {'measure': 'Elbow Range of motion', 'timeFrame': 'Measured when using the RGS-app during the one-time measurement of 1.5 hours', 'description': 'Range of motion in degrees of the elbow joint (0 degrees being fully stretched)'}, {'measure': 'Pelvis range of motion', 'timeFrame': 'Measured when using the RGS-app during the one-time measurement of 1.5 hours', 'description': 'Range of motion in degrees of the elbow joint (0 degrees meaning vertical)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Home-based rehabilitation', 'Augmented reality', 'Upper limb'], 'conditions': ['Stroke', 'Healthy Aging']}, 'descriptionModule': {'briefSummary': "Introduction: Home-based rehabilitation has the potential to reduce healthcare costs. However, due to less supervision in the home situation, it is possible that movements are made incorrectly. Therefore it is important to gain insight in which movements are made with a home-based rehabilitation system and what effects instructions could have on these movements. The current study investigated these movements made by the Rehabilitation Gaming System (RGS) app, this app uses augmented reality to provoke upper limb movements.\n\nMethods: 16 healthy elderly and 16 stroke survivors participate in this study. Each participant was invited to the rehabilitation clinic for a one time measurement of 1.5 hours. During this measurement, four therapy exercises and four games on the RGS-app are performed. Each game should provoke a similar movement as one of the therapy exercises. Participants start with performing the therapy exercises for two minutes each. Thereafter they receive a video instruction on how to perform one of the games of the RGS-app, and they will play this game for 2 minutes. Thereafter the group is randomized into two conditions. The first group receives the same video instruction, while the second group receives a personalized live instruction based on the first two minutes of playing. After the new instruction, participants will play the game for two minutes again. This is repeated for all four games. Both the order of the therapy exercises and RGS-app games are randomized. During the study, participants wear Inertial Measurement Units (IMU's)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stroke survivors will be recruited through a Rehabilitation physician at the Sint Maartenskliniek and if needed through social media.\n\nHealthy elderly will be recruited using social media.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria stroke survivors:\n\n* People who suffered from a stroke at least 2 months ago.\n* Smartphone users\n* Mild to moderate upper limb impairment (Medical Research Council Scale for Muscle Strength (MRC) ≥ 2)\n\nExclusion Criteria stroke survivors:\n\n* Severe cognitive impairment (Montreal Cognitive Assessment \\< 19)\n* Visual impairments (which cannot be corrected with glasses)\n* Upper limb impairments not caused by the stroke\n\nInclusion Criteria healthy elderly:\n\n* 60 years or older\n* Smartphone users\n\nExclusion Criteria healthy elderly:\n\n* Visual impairments (which cannot be corrected with glasses)\n* Upper limb impairments which can affect smartphone use'}, 'identificationModule': {'nctId': 'NCT06516120', 'briefTitle': 'Kinematics of Movements Provoked by an Augmented Reality App', 'organization': {'class': 'OTHER', 'fullName': 'Sint Maartenskliniek'}, 'officialTitle': 'Kinematics of Upper Limb Movements Provoked by an Augmented Reality App in Comparison to Therapy Exercises.', 'orgStudyIdInfo': {'id': '1103'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy elderly', 'description': 'Group of participants who have no prior history of stroke', 'interventionNames': ['Behavioral: RGS-app']}, {'label': 'Stroke survivor', 'description': 'Group of participants who have been through a stroke', 'interventionNames': ['Behavioral: RGS-app']}], 'interventions': [{'name': 'RGS-app', 'type': 'BEHAVIORAL', 'description': 'Participants use the RGS-app on a smartwatch once for 1.5 hours during the measurement. The RGS-app consists of augmented reality games to provoke upper limb movement.', 'armGroupLabels': ['Healthy elderly', 'Stroke survivor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6574 NA', 'city': 'Ubbergen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Merle Matijsen, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sint Maartenskliniek', 'geoPoint': {'lat': 51.8375, 'lon': 5.90139}}], 'centralContacts': [{'name': 'Merle Matijsen, MSc', 'role': 'CONTACT', 'email': 'm.matijsen@maartenskliniek.nl'}], 'overallOfficials': [{'name': 'Noël Keijsers, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Donders Institute for Brain, Cognition and Behavior, Radboud University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sint Maartenskliniek', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eodyne Systems SL', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}