Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:23 AM
Study NCT ID:
NCT07487857
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Somatosensory Camp for Manual Function and Participation in Children With Unilateral Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D010291', 'term': 'Paresis'}], '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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assisting Hand Assessment (AHA)', 'timeFrame': 'Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2)', 'description': 'Change in spontaneous bimanual hand use of the affected upper limb in children with unilateral cerebral palsy, measured by the Assisting Hand Assessment (AHA). The AHA is a video-based, criterion-referenced measure of how effectively a child with a unilateral hand impairment spontaneously uses their affected hand during bimanual play activities. Scores range from 0-100 (higher scores indicate better bimanual performance).'}], 'secondaryOutcomes': [{'measure': 'Melbourne Assessment of Unilateral Upper Limb Function Version 2 (MA-2)', 'timeFrame': 'Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2)', 'description': 'Quality of unilateral upper limb movement (range of motion, accuracy, dexterity, fluency) in children with unilateral cerebral palsy, measured by video analysis using MA-2 standardized criteria.'}, {'measure': 'Somatosensory Function (SWM, 2PD, Stereognosis)', 'timeFrame': 'Baseline (T0), immediately after intervention (T1, 8 days), follow-up at one month (T2)', 'description': 'Tactile discrimination and somatosensory function of the affected hand measured by Semmes-Weinstein Monofilaments (SWM) for touch threshold, two-point discrimination (static/dynamic), localization, double simultaneous stimulation, and stereognosis (object recognition by touch).'}, {'measure': 'Hand Grip Strength (Jamar Dynamometer)', 'timeFrame': 'Baseline (T0), immediately after intervention (T1, 8 days), follow-up at one month (T2)', 'description': 'Maximum cylindrical grip strength (kg) of affected and non-affected hands, measured in standardized sitting position with 3 trials per hand using Jamar hydraulic dynamometer.'}, {'measure': 'Upper Limb Activity (Wrist Accelerometry)', 'timeFrame': 'Baseline (T0), during daily life in camps days, immediately after intervention (T1, 8 days), follow-up at one month (T2)', 'description': 'Objective measurement of spontaneous upper limb movement quantity and intensity using wrist-worn accelerometers on both wrists during AHA assessment and daily life outside camp.'}, {'measure': 'Participation (COPM, PEM-CY)', 'timeFrame': 'Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2)', 'description': 'Family-identified functional priorities and participation in daily activities measured by Canadian Occupational Performance Measure (COPM) performance/satisfaction scores and Participation Environmental Measure-Children and Youth (PEM-CY) frequency/involvement dimensions in school, home and community.'}, {'measure': 'GMFM-66 (Gross Motor Function Measure-66 Item Set)', 'timeFrame': 'Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2)', 'description': 'It is a validated observational instrument that assesses changes in gross motor function in children with cerebral palsy from 5 months to 16 years of age. It consists of 66 items grouped into five dimensions (supine/rolled over, sitting, crawling/kneeling, standing/walking). Scoring is expressed as a percentage (0-100). The Item Set groups the items according to age and the corresponding GMFCS level, thus shortening the assessment and eliminating the need to examine all 66 items of the original GMFM-66. The score is then calculated using the GMAE software.'}, {'measure': 'Pediatric Balance Scale (PBS)', 'timeFrame': 'Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2)', 'description': 'This is a modified version of the Berg Balance Scale for school-aged children (4-15 years) with mild-to-moderate motor disabilities. It assesses 14 functional static/dynamic balance tasks (sitting, standing, reaching, turning). Each item is scored from 0-4 (maximum total 56). It will be used up to age 8 in this study.'}, {'measure': 'Trunk Control Measurement Scale (TCMS-S)', 'timeFrame': 'Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2)', 'description': 'It is used to measure trunk control during functional activities in a seated position. It provides a structured and quantitative assessment of how a person controls their trunk both statically and in motion, including balance, selective trunk movements, and dynamic reach beyond the base of support. It is validated for individuals with neuromotor impairment aged 5 to 19 years.'}, {'measure': "Children's Hand-use Experience Questionnaire (CHEQ", 'timeFrame': 'Baseline (T0), immediately after intervention (T1, 8 days)', 'description': 'This is an online questionnaire completed by parents and/or the child that assesses the perception of hand use during different bimanual activities. It has two versions: the mini-CHEQ for children aged 3-8 years and the CHEQ for children aged 6-18 years. The questionnaire is completed by parents for children under 13 years of age. For children over 13 years of age, both parents and children complete it. It takes 20-30 minutes to complete.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['unilateral cerebral palsy', 'hemiparesis', 'upper limb function', 'somatosensory training', 'intensive rehabilitation', 'bimanual performance', 'pediatric', 'rehabilitation'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'This study will evaluate whether an intensive day camp that combines somatosensory and motor training for the affected upper limb improves hand function and participation in children with unilateral cerebral palsy more than an intensive motor-only camp of equal duration and intensity. Children aged 5 to 15 years with unilateral spastic cerebral palsy and Manual Ability Classification System (MACS) levels I-III will be randomly assigned to one of two intervention groups. The experimental group will receive an 8-day, 40-hour camp including structured tactile, proprioceptive and vestibular stimulation integrated into meaningful functional tasks for the upper limb. The control group will receive an 8-day, 40-hour camp focused exclusively on intensive motor training without specific somatosensory stimulation.\n\nThe primary outcome is the change in spontaneous bimanual performance of the affected hand, measured with the Assisting Hand Assessment (AHA). Secondary outcomes include measures of unilateral upper limb function, somatosensory function, hand grip strength, gross motor function, balance, trunk control, participation in daily activities and objective upper limb activity measured with wrist-worn accelerometers. Outcomes will be assessed at baseline, immediately after the intervention, and at follow-up visits approximately 2 and 3 months after the camp.', 'detailedDescription': 'Unilateral cerebral palsy is a common cause of motor disability in childhood and is frequently associated with somatosensory impairments of the affected upper limb, such as reduced tactile discrimination, impaired proprioception and difficulties with object recognition by touch. These sensory deficits contribute to learned non-use of the affected hand and limited spontaneous bimanual performance in daily activities, even when basic motor abilities are present. Intensive upper limb therapies, such as constraint-induced movement therapy and bimanual training, have shown positive effects on hand function, but most programs focus primarily on motor components and do not systematically target somatosensory function.\n\nThis randomized, controlled, single-blind clinical trial will compare two parallel intensive day-camp interventions for children with unilateral spastic cerebral palsy. Both groups will receive 40 hours of therapy over 8 consecutive days (5 hours per day) in a group-based camp format. The experimental group will participate in a structured somatosensory-motor program that integrates tactile, proprioceptive and vestibular stimulation within play-based, goal-oriented upper limb activities and functional workshops. Daily sessions include sensory activation (e.g., tactile massage, exploration of different textures), intensive tactile discrimination and haptic tasks (e.g., object recognition without vision, graded textures, vibration), and integration of somatosensory input into functional tasks and postural control activities (e.g., balance exercises on unstable surfaces, tasks with light weights).\n\nThe control group will receive an intensive motor-focused camp with the same total dose, schedule and therapist supervision. Activities will target active range of motion, strength, coordination, and functional use of the affected upper limb through standard manual tasks (such as reaching, grasping, building with blocks, threading, and fine motor games) and gross motor upper limb exercises and circuits, without structured somatosensory stimulation.\n\nThe primary objective is to determine whether the somatosensory-motor camp produces greater improvements in spontaneous bimanual performance of the affected hand, assessed by the Assisting Hand Assessment (AHA), compared with the motor-only camp. Secondary objectives include examining changes in unilateral upper limb movement quality (e.g., Melbourne Assessment of Unilateral Upper Limb Function), detailed somatosensory function (e.g., standardized assessments of tactile perception, two-point discrimination, proprioception and stereognosis), grip strength, gross motor function and balance, trunk control, participation and goal attainment, as well as objective upper limb activity recorded by wrist accelerometry in and outside the camp setting. Assessments will be conducted at baseline (T0), immediately after the intervention (T1, after 8 days) and at follow-up visits approximately 2 and 3 months after the camp.\n\nThe study is designed as a minimal-risk pediatric rehabilitation trial and follows ethical and data protection regulations. Randomization will be centralized, and outcome assessors and data analysts will be blinded to group allocation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of spastic CP\n* aged between 5 and 15 years of age\n* able to follow simple verbal instructions and complete all the necessary tests according to their ages\n* MACS level I-III\n\nExclusion Criteria:\n\n* uncontrolled epilepsy episodes in the 6 months prior to the start of the study\n* botulinum toxin in the last 6 months\n* orthopedic or neurological surgery in the 12 months prior to the start of the study or scheduled during the intervention development period\n* visual or cognitive disabilities that interfere with treatment\n* unable to actively participate in the activities'}, 'identificationModule': {'nctId': 'NCT07487857', 'acronym': 'CAMPUSENS', 'briefTitle': 'Intensive Somatosensory Camp for Manual Function and Participation in Children With Unilateral Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'University of Castilla-La Mancha'}, 'officialTitle': 'Intensive Somatosensory Camp for Manual Function and Participation in Children With Unilateral Cerebral Palsy: a Randomnized Controlled Trial', 'orgStudyIdInfo': {'id': 'CAMPUSENS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Somatosensory-Motor Intensive Camp', 'description': '8-day intensive day camp (40 hours total, 5 hours/day) for children with unilateral cerebral palsy. Combines structured somatosensory training (tactile discrimination, texture exploration, vibration stimulation, proprioception, vestibular input) integrated within functional upper limb motor tasks, play-based workshops, and balance activities targeting bimanual hand function and participation.', 'interventionNames': ['Behavioral: Motor-Only Intensive Camp']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: Motor Camp', 'description': '8-day intensive day camp (40 hours total, 5 hours/day) focused exclusively on upper limb motor training for children with unilateral cerebral palsy. Includes active range of motion exercises, strength training, coordination circuits, grasping/manipulation tasks, and fine motor activities without structured somatosensory stimulation', 'interventionNames': ['Behavioral: Somatosensory-Motor Intensive Camp']}], 'interventions': [{'name': 'Somatosensory-Motor Intensive Camp', 'type': 'BEHAVIORAL', 'description': 'Structured 8-day intensive rehabilitation camp (40 hours total, 5 hours/day) for children with unilateral cerebral palsy. Integrates somatosensory stimulation (tactile massage, texture discrimination, vibration therapy, proprioceptive exercises, vestibular/balance activities) within functional upper limb motor tasks, play-based workshops, and bimanual activities targeting spontaneous hand use and participation in daily activities.', 'armGroupLabels': ['Active Comparator: Motor Camp']}, {'name': 'Motor-Only Intensive Camp', 'type': 'BEHAVIORAL', 'description': 'Structured 8-day intensive rehabilitation camp (40 hours total, 5 hours/day) focused exclusively on upper limb motor training for children with unilateral cerebral palsy. Includes active range of motion exercises, grip strength training, fine motor coordination tasks (grasping, threading, block manipulation), reaching/coordination circuits without structured somatosensory stimulation.', 'armGroupLabels': ['Experimental: Somatosensory-Motor Intensive Camp']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rocío Palomo Carrión PhD', 'role': 'CONTACT', 'email': 'rocio.palomo@uclm.es', 'phone': '926051821', 'phoneExt': '+34'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD sharing planned. This minimal-risk pediatric rehabilitation trial involves children with unilateral cerebral palsy (ages 5-15) and includes sensitive clinical data such as video assessments (AHA, MA-2), detailed somatosensory testing, actigraphy, and family-reported functional priorities (COPM). Data cannot be sufficiently de-identified while preserving scientific utility due to the small sample size (n=26) and specialized outcome measures. Aggregate results will be published following CONSORT guidelines.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Castilla-La Mancha', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}