protocolSection identificationModule nctId: NCT06330831, orgStudyIdInfo id: x2ghr8pc, briefTitle: Intensive Group Based CIMT for Young Children, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-05-09, primaryCompletionDateStruct date: 2023-06-28, completionDateStruct date: 2023-07-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Rockhurst University, class: OTHER, collaborators name: Ability KC, descriptionModule briefSummary: This project aims to investigate the effectiveness of an intensive, group-based Constraint Induced Movement Therapy (CIMT) program for young children ages 2-6 years with unilateral hemiparesis, or weakness on one side of the body. This project involves two studies. Study 1 investigates the effect of one dosage of a 1-month, intensive group based CIMT summer program. Study 2 investigates the effect of a repeated, consecutive episode of the intensive, group based CIMT program for children who attended the program the following summer., conditionsModule conditions: Hemiplegic Cerebral Palsy, conditions: Non-Accidental Traumatic Head Injury to Child, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Study 1 is a single group pre-post study of children who received 1 episode of the intensive, group based CIMT intervention (2 data points- pre CIMT 1 and post CIMT1). Study 2 is a repeated measures design to evaluate the long-term effects of the first episode and the effects of the second episode of intensive group based CIMT (4 data points- pre CIMT1; post CIMT1 (at the end of 1 month intervention); pre CIMT 2- 11 months after post of CIMT1; post CIMT 2- 12 months post CIMT 1), primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: No masking occurred for the participants or care providers since all parents/caregivers consented to have their children participate in the intensive group based CIMT intervention. The parents/ care providers knew who the interventionists were. The principal investigator was aware of all participants' assignment to the study. The principal investigator also delivered the intervention to the 2-3-year-old group and also served as the assessor of outcomes along with trained student investigators. The principal investigator attempted to limit bias by having all students achieve an inter-rater reliability level of 90% or above (intra-class correlation coefficient ICC\>.90) on the QUEST and by not allowing the student investigators or herself to consult the pre-intervention assessment outcome scores until after post-intervention outcome assessment scoring was completed., enrollmentInfo count: 35, type: ACTUAL, armsInterventionsModule interventions name: Intensive, Group Based Constraint Induced Therapy (CIMT), outcomesModule primaryOutcomes measure: Quality Upper Extremity Skills Evaluation Test (QUEST), primaryOutcomes measure: Assisting Hand Assessment (AHA), primaryOutcomes measure: Canadian Occupational Performance Measure (COPM), primaryOutcomes measure: Pediatric Evaluation Disability Inventory (PEDI), eligibilityModule sex: ALL, minimumAge: 20 Months, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False