[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658763":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":30,"armGroups":37,"interventions":43,"overallOfficials":30,"centralContacts":48,"locations":54,"responsibleParty":70,"collaborators":30,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":30,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":30,"studyType":87,"phases":88,"briefSummary":89,"conditions":90,"keywords":30,"overallStatus":92,"whyStopped":30,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Faculty of Medicine, Sousse","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"The Melbourne Assessment 2 (MA2)","The Melbourne Assessment 2 (MA2) is a standardized assessment tool used to evaluate the quality of unilateral (one-sided) upper limb function in children with neurological impairments. It focuses on assessing the range of movement, accuracy, dexterity, and fluency of the child's upper limb during specific tasks.\n\nIt reports a child's performance as four separate percentage scores corresponding to each measured element of movement quality.","before and immediately after the intervention",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"Spasticity","Spasticity through the Modified Ashworth Scale (MAS) for elbow and wrist ranging from 0 (normal tone) to 4 (rigid).","before and immediately after intervention",{"measure":19,"description":20,"timeFrame":17},"Muscle strength","Muscle strength grading (MRC) ranging from 0 (no muscle activation) to 5 (normal muscle strength with full power against maximal resistance and a complete range of motion).",{"measure":22,"description":23,"timeFrame":17},"Passive Range of Motion","Upper limb passive range of motion (PROM) in degrees measured with a goniometer.",{"measure":25,"description":26,"timeFrame":17},"The Box and Blocks Test","Unilateral gross manual dexterity (The Box and blocks Test) for the affected limb scored by counting the total number of blocks safely transferred from one compartment to the other in 60 seconds (number of blocks per minute).",{"measure":28,"description":29,"timeFrame":17},"ABILHANDS-KIDS questionnaire","Bimanual ability to manage daily life activities through ABILHANDS-KIDS questionnaire ranging from 0 to 42, with each task is assessed as \"easy\", \"difficult\" or \"impossible\". Raw scores are converted through a psychometric analysis (Rasch model) into a linear measure in logits on a continuous scale.\n\nHigher score: Indicates a better manual ability and greater independence in daily life activities requiring the use of both hands.\n\nLower score: Reveals a significant activity limitation and an increased need for assistance in personal care.",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"NA","SINGLE_GROUP","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":30},"NONE",[38],{"label":39,"type":40,"description":30,"interventionNames":41},"30 children between 5 to 14 years diagnosed with spastic hemiplegic cerebral palsy.","EXPERIMENTAL",[42],"Other: Rehabilitation intervention",[44],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":30},"Rehabilitation intervention","All participants will undergo two assessment sessions, one at baseline and one at the end of the program.\n\nClinical testing will consist of physical examination, assessing unimanual function through the Melbourne Assessment 2 (MA2), unilateral gross manual dexterity (The Box and blocks Test), spasticity through the Modified Ashworth Scale (MAS) for elbow and wrist, muscle strength grading (MRC), upper limb passive range of motion (PROM), and bimanual ability through ABILHANDS-KIDS questionnaire.\n\nThe clinical outcome measures will be recorded by a researcher-resident in physical medicine and rehabilitation.\n\nAfter obtaining the oral consent of the participants' legal guardians, those who met the inclusion criteria will be divided in two groups: The first group will receive a CIMT program, the second group will undergo a VRCIT based-rehabilitation program, both for a period of two weeks. A clinical evaluation will be performed one day before the program.",[39],[49],{"name":50,"role":51,"phone":52,"phoneExt":30,"email":53},"Saoussen Layouni, Associate professor","CONTACT","52785163","layouni.saoussen@FAMSO.u-sousse.tn",[55],{"facility":56,"status":30,"city":57,"state":30,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Department of PMR Sousse","Sousse","4000","Tunisia","TN",{"type":62,"coordinates":63},"Point",[64,65],10.63699,35.82539,{"lat":65,"lon":64},[68],{"name":69,"role":51,"phone":52,"phoneExt":30,"email":53},"saoussen layouni",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Saoussen Layouni","Associate professor","100658763","virtual-reality-augmented-constraint-induced-movement-therapy-versus-conventional-constraint-induced-therapy-for-upper-limb-rehabilitation-in-children-with-unilateral-cerebral-palsy-100658763",false,"NCT07853937","Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.","Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy: A Randomized Controlled Trial.","Inclusion Criteria:\n\n* Able to handle objects in daily life within levels I, II and III on the Gross Motor Function Classification System.\n* Absence of musculoskeletal disorders that impaired the ability of children to use the VR system.\n* Normal or corrected hearing and vision.\n* Able to understand and follow simple directions and perform requested tasks.\n* Tutor Consent.\n\nExclusion Criteria:\n\n* Dizziness during VR sessions.\n* Intolerance to VR environments.\n* Unable to continue or follow the CIMT or VR program.","ALL","4 Years","14 Years",{"count":85,"type":86},30,"ESTIMATED","INTERVENTIONAL",[32],"Cerebral palsy (CP) causes persistent motor and postural impairments that can limit children's functional independence and participation. Upper-limb rehabilitation traditionally relies on conventional therapies, while Virtual Reality (VR) provides an immersive, engaging environment that can improve motor function and quality of life. Constraint-Induced Movement Therapy (CIMT) promotes intensive use of the affected upper limb and has demonstrated benefits in motor and functional outcomes. Recent evidence suggests that combining VR with CIMT (VRCIT) may further improve upper-limb function, hand manipulation, and dexterity. However, in Tunisia, access to CIMT and VR-based rehabilitation remains limited, and no Tunisian study has yet evaluated the effectiveness of VRCIT in children with unilateral CP, highlighting an important research gap.\n\nAim: Evaluate the effectiveness of Virtual Reality-Augmented Constraint-Induced Movement Therapy and constraint-induced movement therapy only in improving unimanual upper limb function in children with unilateral cerebral palsy.",[91],"Cerebral Palsy Spastic Hemiplegic, Quality of Movement","NOT_YET_RECRUITING","2026-09-26",{"date":95,"type":96},"2026-10-02","ACTUAL",{"date":98,"type":86},"2026-10-01",{"date":100,"type":86},"2027-02-28",{"name":5,"class":6},1]