Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:35 PM
Study NCT ID:
NCT07421193
Status:
COMPLETED
Last Update Posted:
2026-02-19
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Video-Based Games on Upper Extremity Function in Children With Hemiparetic Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duruöz Hand Index', 'timeFrame': 'Baseline and immediately after the end of the treatment', 'description': 'The Duruöz Hand Index is an 18-item questionnaire designed to evaluate hand functional capacity. The index consists of five domains: kitchen activities, dressing, personal hygiene, work-related activities, and other daily activities. The questionnaire was completed by parents or caregivers. Responses are scored on a 6-point Likert scale ranging from 0 ("no difficulty") to 5 ("impossible"), yielding a total score between 0 and 90. Higher scores indicate greater impairment of hand function. The validity and reliability of the index for children aged 7-16 years with spastic hemiparetic cerebral palsy have been demonstrated previously.'}, {'measure': 'Assistance to Participation Scale', 'timeFrame': 'Baseline and immediately after the end of the treatment', 'description': "The Assistance to Participation Scale was developed by Bourke-Taylor, Law, Howie, and Pallant to assess the level of assistance required by school-aged children (5-18 years) with developmental disabilities to participate in play, leisure, and recreational activities from the caregiver's perspective. The scale consists of eight items, including activities such as watching television, listening to music, playing alone at home, playing outdoors near home, spending time with friends at home or at a friend's house, visiting playgrounds, and participating in recreational clubs. Items are rated on a 5-point Likert scale, with lower scores indicating lower participation levels and higher scores indicating greater participation."}, {'measure': 'Nine-Hole Peg Test', 'timeFrame': 'Baseline and immediately after the end of the treatment', 'description': 'The Nine-Hole Peg Test was used to assess fine motor skills of the fingers and hand for both upper extremities. Participants were instructed to place nine pegs (3.2 cm in length) into holes on a pegboard as quickly as possible using the dominant hand, followed by removal of the pegs in sequence. The total time required for insertion and removal was recorded in seconds, and the same procedure was repeated for the non-dominant hand. Insertion and removal times for both hands were documented separately. During the task, palmar, lateral, and hook grasp patterns were predominantly observed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Activity Participation', 'Hemiparetic Cerebral Palsy', 'Microsoft Xbox Kinect', 'Upper Extremity Function', 'Video-based Games'], 'conditions': ['Cerebral Palsy', 'Video Game']}, 'descriptionModule': {'briefSummary': 'Aim:\n\nThe present study aimed to systematically evaluate the effects of video-based gaming on upper extremity motor function and activity participation in children with hemiparetic cerebral palsy (CP). Specifically, it investigated whether Microsoft Xbox Kinect games leveraging motion-detection technology, when added to conventional neurodevelopmental therapy (NGT), would provide additional benefits in motor skill development, independence in activities, social engagement, motivation, and treatment adherence compared to NGT alone.\n\nMaterials and Methods:\n\nTwenty-four children aged 7-13 years with hemiparetic CP, classified as Level I-III on the Gross Motor Function Classification System (GMFCS) and Level 1-3 on the Manual Ability Classification System (MACS), were recruited. Participants were randomized into intervention (n=12) and control (n=12) groups. The control group received NGT four times per week (45-minute sessions) over a 12-week period. The intervention group received two NGT sessions and two Xbox Kinect gameplay sessions per week, each lasting 45 minutes, over the same duration.\n\nOutcome measures included the Nine-Hole Peg Test (9HPT) to assess timed hand performance, the Duruöz Hand Index (DHI) to evaluate skill-based hand function, and the Assistance to Participation Scale (APS) to assess participation in daily activities. All assessments were conducted by a blinded expert physiotherapist at baseline and after the intervention period.', 'detailedDescription': 'A total of 27 children meeting the inclusion criteria will be enrolled in the study, and demographic information will be recorded using a standardized data collection form. Participants who do not complete the intervention protocol will be withdrawn from the study. Eligible participants will be randomly assigned to either the study group or the control group using a simple randomization method.\n\nParticipants in the control group will receive neurodevelopmental treatment (NDT) four times per week, with each session lasting 45 minutes, for a total duration of 12 weeks. Participants in the study group will receive NDT twice per week (45 minutes per session) in addition to video-based gaming training using Microsoft Xbox twice per week (45 minutes per session) for 12 weeks.\n\nOutcome assessments will be conducted at baseline and at the end of the 12-week intervention period by an experienced physiotherapist who will be blinded to group allocation. Upper extremity performance will be assessed using the Nine-Hole Peg Test (9HPT), hand function will be evaluated using the Duruöz Hand Index (DHI), and participation in daily activities will be assessed using the Assistance to Participation Scale (APS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 7 and 13 years\n* diagnosis of spastic hemiparetic cerebral palsy\n* participants to be classified at levels I, II, or III according to the Gross Motor Function Classification System (GMFCS) and at levels I, II, or III according to the Manual Ability Classification System (MACS).\n\nExclusion Criteria:\n\n* Children who had undergone upper extremity tendon release surgery or received botulinum toxin injections within the previous six months\n* additional neurological disorders other than cerebral palsy\n* permanent orthopedic conditions affecting upper extremity function'}, 'identificationModule': {'nctId': 'NCT07421193', 'briefTitle': 'Effect of Video-Based Games on Upper Extremity Function in Children With Hemiparetic Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'The Effect of Video-Based Games on Upper Extremity Function and Activity Participation in Children With Hemiparetic Cerebral Palsy', 'orgStudyIdInfo': {'id': 'Şengül Dr Tez'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study', 'description': 'Participants in the study group received NDT twice per week (45 minutes per session) in addition to video-based gaming training using Microsoft Xbox twice per week (45 minutes per session) for 12 weeks.', 'interventionNames': ['Other: neurodevelopmental treatment (NDT)', 'Other: Video-Based Gaming Training Using Microsoft Xbox']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Participants in the control group received neurodevelopmental treatment (NDT) four times per week, with each session lasting 45 minutes, for a total duration of 12 weeks.', 'interventionNames': ['Other: neurodevelopmental treatment (NDT)']}], 'interventions': [{'name': 'neurodevelopmental treatment (NDT)', 'type': 'OTHER', 'description': 'Neurodevelopmental Treatment Upper extremity rehabilitation based on the principles of neurodevelopmental treatment was designed to improve functional use of the upper extremity during daily activities such as dressing, writing, and feeding through the use of everyday objects.', 'armGroupLabels': ['Control', 'Study']}, {'name': 'Video-Based Gaming Training Using Microsoft Xbox', 'type': 'OTHER', 'description': 'Video-Based Gaming Training Using Microsoft Xbox Participants in the study group received video-based gaming training using the Microsoft Xbox gaming console equipped with the Kinect motion-sensing system. Training sessions were conducted twice weekly for 45 minutes over a 12-week period. Each session included volleyball, table tennis, and bowling games, with each game played for 15 minutes.\n\nParticipants performed the games in a comfortable position, either sitting or standing, depending on individual ability (Figure 2). The Kinect sensor captured full-body movements without the need for wearable markers, and the movements of the participants were mirrored in real time by a virtual avatar on the screen.', 'armGroupLabels': ['Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20100', 'city': 'Denizli', 'state': 'Pamukkale', 'country': 'Turkey (Türkiye)', 'facility': 'Pamukkale Üniversitesi', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Fatih Tekin', 'investigatorAffiliation': 'Pamukkale University'}}}}