Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-02 @ 11:02 PM
Study NCT ID:
NCT05328466
Status:
UNKNOWN
Last Update Posted:
2022-09-19
First Post:
2022-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kinect Sensor in Cerebral Palsy Children Phase 2.2
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-16', 'studyFirstSubmitDate': '2022-03-25', 'studyFirstSubmitQcDate': '2022-04-13', 'lastUpdatePostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'range of motion', 'timeFrame': 'before starting the intervention and after finishing the intervention within 1 week', 'description': 'The range or motion of shoulder, elbow and wrist will be assessed by goniometer. The assessment will be done before starting the intervention as the baseline and then after finishing the intervention to detect change of range of motion from the the baseline. The range of motion will be reported in degrees.'}], 'secondaryOutcomes': [{'measure': 'Box and block test', 'timeFrame': 'before starting the intervention and after finishing the intervention within 1 week', 'description': "The name 'box and block test' is an unabbreviated scale title. The minimum score is zero and the maximum score is infinity."}, {'measure': 'ABILHANDS-Kids', 'timeFrame': 'before starting the intervention and after finishing the intervention within 1 week', 'description': 'The ABILHANDS-kids is the name of the test. It is not an unabbreviated name. The children will be asked the difficulty of doing their activities of daily living by using 21 questionnaires. The rating of difficulties were impossible, difficult and easy. Then the rating would be score as impossible=0, difficult=1 and easy = 2. The analysis of the score of there items will use the Rasch analysis which it is available online on http://rssandbox.iescagilly.be/\\~abilhand-kids-cerebral-palsy-en.html. The minimum score means a worse outcome and the maximum score means the better outcome.'}, {'measure': 'EQ-5D-Y', 'timeFrame': 'before starting the intervention and after finishing the intervention within 1 week', 'description': 'The EQ-5D-Y is a questionnaire which has 2 parts for a participants to complete. There are 5 questions asking in first part: mobility, looking after myself, doing usual activities, having pain or discomfort and feelin worried, sad or unhappy. The participant needs to rate these questions in 3 rating score: no problem, with some problem or with a lot of problem. The rating score will be coded as no problem=1, with some problem = 1 and with a lot of problem = 2. The code 11111 is the best condition and the code 33333 is the worst condition. The second part of the questionnaire is the EQ-VAS which the participants need to rate their condition on the linear scale from 0-100. The worst condition is score 0 and the best condition is score 100.Then the coding from the first part will be converted as an index value.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['video-game', 'Kinect sensor', 'upper extremities problems', 'cerebral palsy', 'children'], 'conditions': ['Cerebral Palsy Children', 'Upper Extremity Problem']}, 'referencesModule': {'references': [{'pmid': '21122742', 'type': 'BACKGROUND', 'citation': 'Arneson CL, Durkin MS, Benedict RE, Kirby RS, Yeargin-Allsopp M, Van Naarden Braun K, Doernberg NS. Prevalence of cerebral palsy: Autism and Developmental Disabilities Monitoring Network, three sites, United States, 2004. Disabil Health J. 2009 Jan;2(1):45-8. doi: 10.1016/j.dhjo.2008.08.001.'}, {'pmid': '16437058', 'type': 'BACKGROUND', 'citation': 'Bhasin TK, Brocksen S, Avchen RN, Van Naarden Braun K. Prevalence of four developmental disabilities among children aged 8 years--Metropolitan Atlanta Developmental Disabilities Surveillance Program, 1996 and 2000. MMWR Surveill Summ. 2006 Jan 27;55(1):1-9.'}, {'pmid': '16765723', 'type': 'BACKGROUND', 'citation': 'Paneth N, Hong T, Korzeniewski S. The descriptive epidemiology of cerebral palsy. Clin Perinatol. 2006 Jun;33(2):251-67. doi: 10.1016/j.clp.2006.03.011.'}, {'pmid': '12227618', 'type': 'BACKGROUND', 'citation': 'Prevalence and characteristics of children with cerebral palsy in Europe. Dev Med Child Neurol. 2002 Sep;44(9):633-40.'}, {'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.'}, {'type': 'BACKGROUND', 'citation': 'Samia Abdel Rahman, Abdel Rahman, Afaf A. Shaheen. Virtual Reality Use in Motor Rehabilitation of Neurological Disorders: A Systematic Review. Middle-East Journal of Scientific Research; 7 (1): 63-70.'}, {'pmid': '17895352', 'type': 'BACKGROUND', 'citation': 'Chen YP, Kang LJ, Chuang TY, Doong JL, Lee SJ, Tsai MW, Jeng SF, Sung WH. Use of virtual reality to improve upper-extremity control in children with cerebral palsy: a single-subject design. Phys Ther. 2007 Nov;87(11):1441-57. doi: 10.2522/ptj.20060062. Epub 2007 Sep 25.'}, {'pmid': '21978233', 'type': 'BACKGROUND', 'citation': 'Green D, Wilson PH. Use of virtual reality in rehabilitation of movement in children with hemiplegia--a multiple case study evaluation. Disabil Rehabil. 2012;34(7):593-604. doi: 10.3109/09638288.2011.613520. Epub 2011 Oct 6.'}, {'type': 'BACKGROUND', 'citation': 'Pruksananonda C. Cerebral Palsy. In: Prasongjean P, editor. Cerebral Palsy Disease. Bangkok: Chulalongkorn University Printing House; 2010. p. 1-3.'}]}, 'descriptionModule': {'briefSummary': 'There are 3 phase of the study. This registration is phase 2.2. This registration will conduct a randomized controlled trial study in the cerebral palsy children. Due to the limitation of period of time of grant, we changed the study type into pilot-randomization. Our new method of study will collect all of our study which previously separated into pilot and randomized controlled trial in just only one study "pilot-randomization".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spastic cerebral palsy aged 10-15 years\n* Sufficient cognitive/attention capacity to understand basic instructions\n* Can cooperate with the therapist for short period of time during training\n* Manual Ability Classification System (MACS) 2-3\n* Zancolli classification of the affected upper extremity was grade I-II.\n* Give the informed consent\n\nExclusion Criteria:\n\n* Inability to understand the instruction and follow the task\n* Severe comorbidities, visual or auditory impairment\n* Had history of Botulinum toxin injection on the affected upper extremity for last 6 months or receive the injection during the study time\n* Other treatment options planned on the affected upper extremity during the study time\n* Wear daytime orthosis on the affected limb\n* Zancolli classification of the affected hand was grade III.\n* Got an epilepsy or convulsive condition\n* Denied to give the informed consent or continue the study'}, 'identificationModule': {'nctId': 'NCT05328466', 'briefTitle': 'Kinect Sensor in Cerebral Palsy Children Phase 2.2', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'The Engineer-built System, Video-game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children', 'orgStudyIdInfo': {'id': 'MURA2021/768-2.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'video game in CP children', 'description': 'Children in this arm will play the computer game which was developed by the researcher team 3 session/weeks for 5 weeks. Each session will last for 40 minutes.', 'interventionNames': ['Device: The engineer-built system, video-game based Kinect sensor']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional therapy', 'description': 'children in this arm will receive a conventional program by occupational therapists 3 times/week for 5 weeks. Each session will last for 40 minutes.'}], 'interventions': [{'name': 'The engineer-built system, video-game based Kinect sensor', 'type': 'DEVICE', 'otherNames': ['conventional occupational therapy program'], 'description': 'The games were developed by the researcher team.', 'armGroupLabels': ['video game in CP children']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nonthaburi', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Amprai Surit, occupational therapist', 'role': 'CONTACT', 'email': 's_amprai@hotmail.com'}], 'facility': 'Srisangwan School Foundation for the Welfare of the Crippled under Royal Patronage of Her Royal Highness the Princess Mother', 'geoPoint': {'lat': 13.86075, 'lon': 100.51477}}], 'centralContacts': [{'name': 'Sivaporn Vongpipatana, MD.', 'role': 'CONTACT', 'email': 'sivaporn.vop@mahidol.ac.th', 'phone': '022011154'}, {'name': 'Apiphan Iamchaimongkol, MD.', 'role': 'CONTACT', 'email': 'beebie18z@gmail.com', 'phone': '022011154'}], 'overallOfficials': [{'name': 'Sivaporn Vongpipatana', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine Ramathibodi Hospital Mahidol University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': 'after harvesting the data within 3 months', 'ipdSharing': 'YES', 'description': 'I plan to share the result with the statistician and some researcher for the analysis. The sharing could not be track to the patient identification.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Warakorn Charoensuk', 'class': 'UNKNOWN'}, {'name': 'Apiphan Iamchaimongkol', 'class': 'UNKNOWN'}, {'name': 'Tulyapruek Tawonsawatruk', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sivaporn Vongpipatana', 'investigatorAffiliation': 'Mahidol University'}}}}