Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT05299905
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2022-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ImGTS for Patients With Cerebral Palsy and With Mobility Limitations
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-31', 'studyFirstSubmitDate': '2022-02-06', 'studyFirstSubmitQcDate': '2022-03-18', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 1", 'timeFrame': 'Immediately before Session 1, within an hour of before use of the virtual reality game', 'description': "Baseline assessment for the presence of cybersickness symptoms for Session 1 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety."}, {'measure': "Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 1", 'timeFrame': 'Immediately after Session 1, within an hour of completion of the virtual reality game', 'description': "Assessment for the occurrence of cybersickness symptoms for Session 1 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety."}, {'measure': "Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 2", 'timeFrame': 'Immediately before Session 2, within an hour of before use of the virtual reality game', 'description': "Baseline assessment for the presence of cybersickness symptoms for Session 2 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety."}, {'measure': "Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 2", 'timeFrame': 'Immediately after Session 2, within an hour of completion of the virtual reality game', 'description': "Assessment for the occurrence of cybersickness symptoms for Session 2 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety."}, {'measure': "Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 3", 'timeFrame': 'Immediately before Session 3, within an hour of before use of the virtual reality game', 'description': "Baseline assessment for the presence of cybersickness symptoms for Session 3 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety."}, {'measure': "Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 3", 'timeFrame': 'Immediately after Session 3, within an hour of completion of the virtual reality game', 'description': "Assessment for the occurrence of cybersickness symptoms for Session 3 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety."}, {'measure': "Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 4", 'timeFrame': 'Immediately before Session 4, within an hour of before use of the virtual reality game', 'description': "Baseline assessment for the presence of cybersickness symptoms for Session 4 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety."}, {'measure': "Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 4", 'timeFrame': 'Immediately after Session 4, within an hour of completion of the virtual reality game', 'description': "Assessment for the occurrence of cybersickness symptoms for Session 4 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety."}, {'measure': 'The acceptability of the design for Session 1 will be measured using the Place Probe', 'timeFrame': 'Immediately after Session 1, within an hour of completion of the virtual reality game', 'description': "The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion"}, {'measure': 'The acceptability of the design for Session 2 will be measured using the Place Probe', 'timeFrame': 'Immediately after Session 2, within an hour of completion of the virtual reality game', 'description': "The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion"}, {'measure': 'The acceptability of the design for Session 3 will be measured using the Place Probe', 'timeFrame': 'Immediately after Session 3, within an hour of completion of the virtual reality game', 'description': "The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion"}, {'measure': 'The acceptability of the design for Session 4 will be measured using the Place Probe', 'timeFrame': 'Immediately after Session 4, within an hour of completion of the virtual reality game', 'description': "The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion"}, {'measure': 'Observation of completion of the game in the given time during Session 4 to measure effectiveness of the application', 'timeFrame': 'For one hour during Session 4', 'description': 'Effectiveness is a component of usability, and will be assessed through observing completion of the game within the allotted time. If at least 85% of the participants complete the game within the allotted time, the game is said to be effective.'}, {'measure': 'Observation of ease of use of controls and user interaction during Session 4 to measure efficiency of the application during Session 4', 'timeFrame': 'For one hour during Session 4', 'description': "Efficiency is a component of usability that will assess a participant's ease of use of the controls and user interface during the experience. If at least 85% of the participants do not encounter or express difficulties in using the application during the experience, the game is said to be efficient."}, {'measure': 'Observation of user reactions to measure satisfaction in using the application through during Session 4', 'timeFrame': 'For one hour during Session 4', 'description': "Satisfaction is a component of usability that will assess a participant's enjoyment in using the game. It will be assessed through observing the reaction of the participant during Session 4. If 90% of the participants visibly show or verbally express enjoyment during the experience, the game is said to be satisfactory."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '23961782', 'type': 'BACKGROUND', 'citation': 'Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.'}, {'pmid': '30702436', 'type': 'BACKGROUND', 'citation': 'Birckhead B, Khalil C, Liu X, Conovitz S, Rizzo A, Danovitch I, Bullock K, Spiegel B. Recommendations for Methodology of Virtual Reality Clinical Trials in Health Care by an International Working Group: Iterative Study. JMIR Ment Health. 2019 Jan 31;6(1):e11973. doi: 10.2196/11973.'}, {'pmid': '29088476', 'type': 'BACKGROUND', 'citation': 'Chen Y, Fanchiang HD, Howard A. Effectiveness of Virtual Reality in Children With Cerebral Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2018 Jan 1;98(1):63-77. doi: 10.1093/ptj/pzx107.'}, {'pmid': '33825690', 'type': 'BACKGROUND', 'citation': 'Demers M, Fung K, Subramanian SK, Lemay M, Robert MT. Integration of Motor Learning Principles Into Virtual Reality Interventions for Individuals With Cerebral Palsy: Systematic Review. JMIR Serious Games. 2021 Apr 7;9(2):e23822. doi: 10.2196/23822.'}, {'pmid': '29477332', 'type': 'BACKGROUND', 'citation': 'Kim HK, Park J, Choi Y, Choe M. Virtual reality sickness questionnaire (VRSQ): Motion sickness measurement index in a virtual reality environment. Appl Ergon. 2018 May;69:66-73. doi: 10.1016/j.apergo.2017.12.016. Epub 2018 Jan 16.'}, {'pmid': '23962350', 'type': 'BACKGROUND', 'citation': 'Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21.'}, {'pmid': '28441773', 'type': 'BACKGROUND', 'citation': 'Paulson A, Vargus-Adams J. Overview of Four Functional Classification Systems Commonly Used in Cerebral Palsy. Children (Basel). 2017 Apr 24;4(4):30. doi: 10.3390/children4040030.'}, {'pmid': '17370477', 'type': 'BACKGROUND', 'citation': 'Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.'}, {'pmid': '19191834', 'type': 'BACKGROUND', 'citation': 'Sandlund M, McDonough S, Hager-Ross C. Interactive computer play in rehabilitation of children with sensorimotor disorders: a systematic review. Dev Med Child Neurol. 2009 Mar;51(3):173-9. doi: 10.1111/j.1469-8749.2008.03184.x. Epub 2009 Jan 26.'}, {'pmid': '23106530', 'type': 'BACKGROUND', 'citation': 'Smits-Engelsman BC, Blank R, van der Kaay AC, Mosterd-van der Meijs R, Vlugt-van den Brand E, Polatajko HJ, Wilson PH. Efficacy of interventions to improve motor performance in children with developmental coordination disorder: a combined systematic review and meta-analysis. Dev Med Child Neurol. 2013 Mar;55(3):229-37. doi: 10.1111/dmcn.12008. Epub 2012 Oct 29.'}, {'pmid': '32691059', 'type': 'BACKGROUND', 'citation': 'Weber H, Barr C, Gough C, van den Berg M. How Commercially Available Virtual Reality-Based Interventions Are Delivered and Reported in Gait, Posture, and Balance Rehabilitation: A Systematic Review. Phys Ther. 2020 Sep 28;100(10):1805-1815. doi: 10.1093/ptj/pzaa123.'}, {'pmid': '15679949', 'type': 'BACKGROUND', 'citation': 'Weiss PL, Rand D, Katz N, Kizony R. Video capture virtual reality as a flexible and effective rehabilitation tool. J Neuroeng Rehabil. 2004 Dec 20;1(1):12. doi: 10.1186/1743-0003-1-12.'}]}, 'descriptionModule': {'briefSummary': 'The proposed research project aims to answer the question "Are immersive technology systems effective in the rehabilitation management of pediatric patients with cerebral palsy and with mobility limitations?". The current study is the first of three phases, and it aims to create an immersive gamification technology system for the management of patients with cerebral palsy and with mobility disorders and to determine its acceptability, usability, and safety in healthy children.', 'detailedDescription': "The participants will undergo an intervention using the assigned ImGTS for four sessions (twice a week for two weeks) for at most 1 hour per session. The experience will last for at most 20 minutes, interspersed with 5- to 20-minute breaks. The researchers will document the participants' reaction and interaction with the ImGTS. Participants will be staying at the designated laboratory for not more than one hour.\n\nDemographic characteristics of the participant (age, sex, educational level, primary caregiver, list of medications, hobbies and interests, previous experience with VR applications, existing illnesses and medications) will be collected through an interview with the child and the participant's parent, legal guardian, or caregiver.\n\nSafety will be determined by assessing a participant's experience of cybersickness using a cybersickness questionnaire that will be administered before and after each session. In this self-report questionnaire, nine symptoms will be rated as absent/none, slight, moderate, or severe. These symptoms are general discomfort, fatigue, eyestrain, difficulty focusing, headache, fullness of head, blurred vision, dizziness when the eyes are closed, and vertigo. The questionnaire will take around 10 minutes to complete. If a participant will experience severe cybersickness, the participant may opt to discontinue the experience. The participant will be instructed to remove the HMD or to step out of the Semi-CAVE room to rest and recover from the symptoms. A medical professional will be present to monitor the participant's symptoms and to attend to the participant for further management. The reason(s) for discontinuing the experience will be documented.\n\nThe acceptability of the design will be measured using the Place Probe, a sense of place questionnaire. The questionnaire will be administered after each session, and it will collect information on a participant's experience in the VR application, particularly on (1) general impression of the environment, (2) the key features of the environment, and (3) feelings of presence. A positive general impression, a memorable environment, and a high level of presence will indicate that the VE developed is acceptable. This will take about 10 minutes to complete.\n\nUsability testing will be performed according to the PNS ISO/IEC Metrics. The goal is to provide continuous improvement in the design and user experience to maximize the three components of usability: effectiveness, efficiency, and satisfaction. Additional usability metrics will be identified during the first phase of the study. The metrics will be specifically adjusted to the target participants as well as the contents to be included in the ImGTS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 6 to 12 years old\n* Demonstrates fine and gross motor abilities within the norm for the child's age as measured by the Bruininks-Oseretsky Test of Motor Proficiency Test (BOTMP)\n\nExclusion Criteria:\n\n* Previously diagnosed with any developmental disorder including CP\n* Has had episodes of seizures or previously diagnosed as having epilepsy\n* Has a history of motion sickness\n* Unable to follow one-step instructions"}, 'identificationModule': {'nctId': 'NCT05299905', 'briefTitle': 'ImGTS for Patients With Cerebral Palsy and With Mobility Limitations', 'organization': {'class': 'OTHER', 'fullName': 'Augmented eXperience E-health Laboratory'}, 'officialTitle': 'Developing Immersive Gamification Technology System (ImGTS) for Rehabilitation Management of Pediatric Patients With Cerebral Palsy and With Mobility Limitations (Phase 1 Trial)', 'orgStudyIdInfo': {'id': 'AXEL0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Semi-CAVE', 'interventionNames': ['Procedure: Virtual reality using Semi-CAVE']}, {'type': 'EXPERIMENTAL', 'label': 'Head-mounted display system', 'interventionNames': ['Procedure: Virtual reality using the HMD']}], 'interventions': [{'name': 'Virtual reality using Semi-CAVE', 'type': 'PROCEDURE', 'description': 'The Semi-CAVE will use two screens positioned at a corner of the room, each with a ceiling-mounted short throw projector in front. The participant will stand in the middle of the area, giving them a viewing angle of roughly 180 degrees. The participant will be wearing a safety harness secured to an overhead guide rail, if necessary. The participant may be standing freely, on a treadmill, or on a step stool depending on the type of activity to be performed. The participant will interact with the system through motion sensors positioned at the corners of the area. To one side of the area will be a sufficiently powerful computer running the software. The projectors will be connected to this computer via HDMI cables or similar.', 'armGroupLabels': ['Semi-CAVE']}, {'name': 'Virtual reality using the HMD', 'type': 'PROCEDURE', 'description': 'The HMD will be a commercially available device that uses handheld controllers to control movement while in the VE. The researchers will use a room-scale set-up where a 3 m x 3 m square space is required. Oculus Quest 2 Controllers will be used to interact with the VE. The user will be positioned at the center of the square by default. A therapist will assist them through a separate program called the Observation Module. This program will let the therapist view what the patient can see in the HMD. This will also be used by the therapist to guide the patient navigate through the VE and give instructions for the activities.', 'armGroupLabels': ['Head-mounted display system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Manila', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'College of Allied Medical Professions Clinic for Therapy Services', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}], 'overallOfficials': [{'name': 'Maria Eliza R Aguila, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of the Philippines Manila'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augmented eXperience E-health Laboratory', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}