Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT06317935
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Virtual Reality Application on Independence and Hand Functions in Daily Life in Children With CP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Two groups, intervention (A) and control (B), will be created from the target research group using the randomization method.\n\nIntervention group (A) will receive virtual reality application for 30 minutes, 5 days a week for 3 weeks, in addition to traditional occupational therapy and physiotherapy approaches for the first 3 weeks, and will receive only traditional treatments between 3-6 weeks.\n\nThe control group (B) will receive only traditional occupational therapy and physiotherapy approaches for the first 3 weeks, and between 3-6 weeks, they will receive virtual reality application in addition to traditional approaches for 30 minutes, 5 days a week for 3 weeks.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-10-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2024-02-20', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of virtual reality applications on perceived independence in daily life in hemiplegic CP.', 'timeFrame': 'At the end of the 6th week', 'description': "The independence levels perceived by children with hemiplegic CP in daily life will be evaluated with the Children's Hand Use Experience Questionnaire."}, {'measure': 'The effect of virtual reality applications on upper extremity functionality in daily life in children with hemiplegic CP.', 'timeFrame': 'At the end of the 6th week', 'description': 'The impact on the upper extremity functionality of children with hemiplegic CP in daily life will be evaluated with the Pediatric Motor Activity Log-Revised test.'}], 'secondaryOutcomes': [{'measure': 'Dosimetry of virtual reality applications', 'timeFrame': 'At the end of the 6th week', 'description': 'As suggested in further research, examining the dosimetric properties of virtual reality applications such as frequency and duration and comparing them with other studies.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Upper Extremity', 'Hemiplegic Cerebral Palsy'], 'conditions': ['Hemiplegic Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '24819682', 'type': 'BACKGROUND', 'citation': 'Chen YP, Lee SY, Howard AM. Effect of virtual reality on upper extremity function in children with cerebral palsy: a meta-analysis. Pediatr Phys Ther. 2014 Fall;26(3):289-300. doi: 10.1097/PEP.0000000000000046.'}, {'pmid': '35237486', 'type': 'BACKGROUND', 'citation': 'Goyal C, Vardhan V, Naqvi W. Virtual Reality-Based Intervention for Enhancing Upper Extremity Function in Children With Hemiplegic Cerebral Palsy: A Literature Review. Cureus. 2022 Jan 28;14(1):e21693. doi: 10.7759/cureus.21693. eCollection 2022 Jan.'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is to evaluate the effect of virtual reality applications on the level of independence and upper extremity functionality perceived by children in daily life in children with hemipegic cerebral palsy.\n\nThe research is a randomized controlled, cross-over study. The sample group of the research is children diagnosed with hemiplegic cerebral palsy and families who are receiving inpatient treatment in the pediatric service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital.\n\nTwo groups, intervention (A) and control (B), will be created from the target research group using the randomization method.\n\nThe upper extremity functionality of both research groups before the intervention will be evaluated with the 'Motor Activity Diary for Children' scale and the perceived independence level with the 'Children's Hand Use Experience' scale.\n\nAfter the initial evaluation is completed, group A, represented as the intervention group, will receive ArmeoSenso virtual reality intervention in the upper extremity hand function laboratory for 3 weeks, 5 days a week, each session for 30 minutes, in addition to traditional occupational therapy and physiotherapy rehabilitation programs. Meanwhile, group B, represented as the control group, will continue the traditional occupational therapy and physiotherapy rehabilitation program. At the end of the third week of the intervention, tests measuring upper extremity functionality and perceived independence level will be repeated.\n\nMeasurement tools will be repeated at the beginning of the intervention, at the end of the 3rd week, and at the end of the intervention.", 'detailedDescription': "The sample group of the research is children between the ages of 6-12, diagnosed with hemiplegic cerebral palsy, who are receiving inpatient treatment in the pediatric service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital, and their families.\n\nStatistical power analysis was performed to calculate the number of people required to be included in the study. Statistical power analysis was performed with G\\*Power v.3.1.9.7 software. In the analysis, the Type 1 error margin (α) was accepted as 5% and the desired statistical power (1-β) was accepted as 0.80. In order to carry out the analysis, randomized controlled studies in the literature on the subject that reported effect sizes were examined. Studies have found that in virtual reality-based interventions applied to children with cerebral palsy, strong to very strong effect sizes were reported between intervention and control groups in variables such as upper extremity functions and performance in daily living activities (4, 7-11). When calculations were made using the strong effect size (Cohen's d = 0.80) in the sample size analysis, it was determined that the smallest sample size that needed to be reached for both groups was 26. Therefore, a total of 52 people were included in the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Having a diagnosis of hemiplegic SP\n* Being between the ages of 6-12\n* Not having any fixed contracture in the upper extremity\n* According to the Modified Ashworth Scale, the upper extremity spasticity value is at the level of 1,1+,2 or 3\n* Being at level I, II or III according to the Gross Motor Function Classification System (GMFCS)\n* Being at level II or III according to the Manual Ability Classification System (MACS)\n* Being at level I, II or III according to the Communication Function Classification System (CFCS)\n* Being within the normal cognitive level according to the Modified Pediatrics Mini Mental Test score\n* Being at level I, II or III according to the Eating and Drinking Ability Classification System (EDACS)\n* Being at level I, II or III according to the Visual Function Classification System for Children with Cerabral Palsy (VFCS)\n* Volunteering to participate in the study\n\nExclusion Criteria:\n\n* Having botolinum toxin injection within the last 6 months\n* Having undergone a surgical procedure within the last 1 year\n* Fracture, trauma, etc. in the upper extremity. to live'}, 'identificationModule': {'nctId': 'NCT06317935', 'briefTitle': 'The Effect of Virtual Reality Application on Independence and Hand Functions in Daily Life in Children With CP', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'The Effect of Virtual Reality Intervention on Upper Extremity Functioning and Perceived Independence in Daily Life in Children With Hemiplegic Cerebral Palsy', 'orgStudyIdInfo': {'id': 'HU-ERG-BK-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ArmeoSenso', 'description': 'ArmeoSenso virtual reality application will be applied to group A in the 0-3 weeks of the study and to group B in the 3-6 weeks.', 'interventionNames': ['Other: ArmeoSenso', 'Other: Traditional Rehabilitation']}, {'type': 'OTHER', 'label': 'Traditional rehabilitation', 'description': 'Traditional rehabilitation (physiotherapy and occupational therapy) approaches will continue to be applied to groups A and B at all stages of the research.', 'interventionNames': ['Other: Traditional Rehabilitation']}], 'interventions': [{'name': 'ArmeoSenso', 'type': 'OTHER', 'description': "ArmeoSenso is an upper extremity virtual reality application with three motion sensors and one hand grip sensor. The device detects the person's body, arm, forearm and hand movements and displays the reflection of the movements on the screen. The application includes studies on upper extremity functions.", 'armGroupLabels': ['ArmeoSenso']}, {'name': 'Traditional Rehabilitation', 'type': 'OTHER', 'description': 'It includes traditional occupational therapy and physiotherapy approaches.', 'armGroupLabels': ['ArmeoSenso', 'Traditional rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Multiple Locations', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Başak Karadağ, MSc', 'role': 'CONTACT', 'email': 'basakhacettepe@hotmail.com', 'phone': '+905059462128'}, {'name': 'Berke Aras, Ass. Prof.', 'role': 'CONTACT', 'email': 'drberkearas@gmail.com', 'phone': '+90365851518'}], 'facility': 'Ankara Bilkent City Hospital'}], 'centralContacts': [{'name': 'Başak Karadağ, MSc.', 'role': 'CONTACT', 'email': 'karadagbasak@outlook.com', 'phone': '+905059462128'}, {'name': 'Meral Huri, Professor', 'role': 'CONTACT', 'email': 'mrlhuri@gmail.com', 'phone': '+905335515590'}], 'overallOfficials': [{'name': 'Başak Karadağ, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital Bilkent'}, {'name': 'Meral Huri, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hacettepe University'}, {'name': 'Berke Aras, Ass.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital Bilkent'}, {'name': 'Özge Tezen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ankara City Hospital Bilkent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only the principal investigator can access information about individuals; other researchers will not be able to access this information due to blinding.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Occupational Therapist, PhD Student', 'investigatorFullName': 'Basak Karadag', 'investigatorAffiliation': 'Hacettepe University'}}}}