Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:02 AM
Study NCT ID:
NCT07421505
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Mobility in Children With Cerebral Palsy: NDT-Bobath and Exergaming
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537945', 'term': 'Cerebral palsy, spastic, diplegic'}, {'id': 'D006429', 'term': 'Hemiplegia'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The participants will be randomly assigned to one of two groups. Group I: NDT-Bobath therapy supplemented with exergaming performed in a sitting position using Kinect Therapy-Based Exergames.\n\nGroup II: NDT-Bobath therapy supplemented with exergaming performed in a standing position using the same systems.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cervical Spine Mobility', 'timeFrame': 'Baseline, post-intervention (3 months), follow-up (6 months)', 'description': 'Change in active cervical spine range of motion in children with cerebral palsy aged 10-15 years, measured in sagittal, frontal, and transverse planes using the CROM device. Cervical flexion/extension, lateral flexion, and rotation are expressed in degrees.'}, {'measure': 'Thoracic Spine Mobility', 'timeFrame': 'Baseline, post-intervention (3 months), follow-up (6 months)', 'description': 'Change in thoracic spine mobility measured as active range of motion and trunk rotation using the MyoMotion system. Measurements are expressed in degrees and reflect thoracic flexion/extension, lateral flexion, and rotational movements.'}, {'measure': 'Lumbar Spine Mobility', 'timeFrame': 'Baseline, post-intervention (3 months), follow-up (6 months)', 'description': 'Change in lumbar spine mobility measured as active range of motion using the MyoMotion system. Lumbar flexion/extension, lateral flexion, and rotation are expressed in degrees.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral palsy', 'Spinal mobility', 'NDT-Bobath therapy', 'Exergaming'], 'conditions': ['Spastic Diplegia Cerebral Palsy', 'Spastic Hemiplegia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate changes in spinal mobility in the cervical, thoracic, and lumbar regions in children with cerebral palsy aged 10-15 years. The study will compare outcomes between standard NDT-Bobath therapy supplemented with exergaming in a sitting position and exergaming in a standing position. Postural stability, body composition, and functional parameters will also be assessed.\n\nParticipants will complete a socio-medical questionnaire and undergo baseline measurements of spinal mobility, cervical range of motion, postural stability (using Podoscan and Zebris platform), body height, and body composition (using SECA stadiometer and Tanita bioimpedance analyzer).\n\nThe intervention will last 3 months and include twice-weekly 60-minute therapy sessions. Group I will receive NDT-Bobath therapy supplemented with exergaming in a sitting position, while Group II will receive NDT-Bobath therapy with exergaming in a standing position.\n\nAfter the intervention, participants will undergo post-intervention measurements and a follow-up evaluation three months later to assess the persistence of any changes.', 'detailedDescription': "This study aims to evaluate the effects of NDT-Bobath therapy supplemented with exergaming on spinal mobility in children with cerebral palsy (CP) aged 10-15 years. Based on these calculations, a representative study sample includes 42 participants.\n\nEligible participants are children diagnosed by a physician with spastic diplegia (G80.1) or spastic hemiplegia (G80.2), the two most common clinical phenotypes of CP, representing approximately 35% and 25% of cases, respectively. Participants will be randomly assigned to two intervention groups:\n\nGroup I: NDT-Bobath therapy supplemented with exergaming performed in a sitting position.\n\nGroup II: NDT-Bobath therapy supplemented with exergaming performed in a standing position.\n\nParticipants' data will only be included in the final analysis if their attendance at therapy sessions is at least 85%.\n\nThe study will be conducted in four stages:\n\nStage I - Pilot Study:\n\nA pilot study with 15 participants (who will not participate in the main study) will determine the optimal duration for measuring center-of-pressure sway in children aged 10-15 with CP. Postural stability will be assessed using posturography, Podoscan, and the Zebris platform. Zebris measurements will be dynamic and last 30, 60, and 90 seconds. Baseline assessments will include:\n\nSocio-medical questionnaire covering personal, medical, physiotherapy, educational data, orthopedic equipment usage, physical and therapeutic activities, and nutrition.\n\nLumbar and thoracic spinal mobility in sagittal and transverse planes and kinematic chain mobility (lumbar spine, pelvic girdle, and lower limbs) using the MyoMotion system.\n\nCervical spine active range of motion using the CROM device in sagittal, frontal, and horizontal planes.\n\nBody height via SECA 213 stadiometer and body composition (general and segmental fat mass, lean mass, estimated muscle mass) via Tanita bioimpedance analyzer.\n\nStage II - Intervention:\n\nThe intervention program will last 3 months, with 60-minute sessions twice weekly at a collaborating rehabilitation center.\n\nGroup I (sitting exergaming): NDT-Bobath therapy with exercises for muscle tone normalization in the pelvic girdle, central stability enhancement including trunk rotation, and exercises for shoulder girdle tone normalization. Therapy sessions follow three core NDT principles: facilitation, stimulation, and communication. Exergaming will be performed in a seated position with hips, knees, and ankles at 90°, allowing gradual position changes between exercises to manage child concentration.\n\nGroup II (standing exergaming): NDT-Bobath therapy with similar exercises as Group I, but exergaming performed in a standing position with appropriate posture. Session structure includes adjustments for position changes and attention management.\n\nParticipants will be classified according to compensatory patterns:\n\nType A/A: symmetrical antigravity pattern\n\nType P/P: symmetrical progravity pattern\n\nType A/P: mixed antigravity/progravity pattern\n\nExergaming will use Kinect Therapy-Based Exergames with Microsoft Kinect.\n\nStage III - Post-intervention Assessment:\n\nSpinal mobility (lumbar, thoracic, cervical) will be reassessed using the same instruments as in Stage I.\n\nStage IV - Follow-up:\n\nA repeat assessment identical to Stage III will be conducted 3 months after the intervention to evaluate the persistence of therapeutic effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent from parents/guardians and the child (if capable)\n* GMFCS levels I-III (mild to moderate motor limitations)\n* Ability to maintain standing position\n* Ability to follow instructions and perform exercises\n* No prior exergaming therapy\n* No implanted electronic devices\n* No acute infections or inflammatory conditions\n* No metabolic disorders affecting bioimpedance measurements\n\nExclusion Criteria:\n\n* GMFCS levels IV-V\n* Orthopedic surgery within the past 12 months\n* Seizure episodes within the past 6 months\n* Cognitive or behavioral impairments preventing cooperation\n* Severe spinal deformities (scoliosis \\>40° or other significant changes)\n* Attendance at therapy sessions \\<85%'}, 'identificationModule': {'nctId': 'NCT07421505', 'briefTitle': 'Spinal Mobility in Children With Cerebral Palsy: NDT-Bobath and Exergaming', 'organization': {'class': 'OTHER', 'fullName': 'Wroclaw University of Health and Sport Sciences'}, 'officialTitle': 'Spinal Mobility in Children With Cerebral Palsy Undergoing NDT-Bobath Therapy and Exergaming-based Therapy', 'orgStudyIdInfo': {'id': 'WroclawUHSS Ethics (34/2025)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NDT-Bobath + Sitting Exergaming', 'description': "Participants in this group will receive standard NDT-Bobath therapy supplemented with exergaming performed in a seated position. Therapy sessions will last 60 minutes, twice weekly, for 3 months.\n\nThe NDT-Bobath component focuses on:\n\nNormalizing muscle tone in the pelvic and shoulder girdle Enhancing central trunk stability, including trunk rotation Promoting symmetrical posture and controlled movement according to NDT principles (facilitation, stimulation, communication)\n\nThe exergaming component will be performed while seated on a chair with adjustable height to achieve 90° flexion at hips, knees, and ankles. Exercises will engage three-dimensional trunk and limb movements, be visually engaging, and allow personalization according to each child's functional level. Exercises are safe, non-impact, and synchronized with the MyoMotion system for monitoring.", 'interventionNames': ['Other: NDT-Bobath Therapy', 'Other: Sitting Exergaming']}, {'type': 'EXPERIMENTAL', 'label': 'NDT-Bobath + Standing Exergaming', 'description': "Participants in this group will receive standard NDT-Bobath therapy supplemented with exergaming performed in a standing position. Therapy sessions will last 60 minutes, twice weekly, for 3 months.\n\nThe NDT-Bobath component focuses on:\n\nNormalizing muscle tone in the pelvic and shoulder girdle Enhancing central trunk stability, including trunk rotation Promoting symmetrical posture and controlled movement according to NDT principles (facilitation, stimulation, communication)\n\nThe exergaming component will be performed in a standing position, promoting weight-bearing and functional trunk and limb control. Exercises engage three-dimensional movements, are visually appealing, and personalized according to the child's functional abilities. Exercise intensity is safe and designed to prevent injury, with position adjustments between exercises as needed. Exercises are synchronized with the MyoMotion system for real-time monitoring.", 'interventionNames': ['Other: NDT-Bobath Therapy', 'Other: Standing Exergaming']}], 'interventions': [{'name': 'NDT-Bobath Therapy', 'type': 'OTHER', 'otherNames': ['Neurodevelopmental Treatment (Bobath Concept)'], 'description': 'Standard NDT-Bobath neurodevelopmental therapy focusing on normalization of muscle tone in the pelvic and shoulder girdle, enhancement of central trunk stability including rotational control, and promotion of symmetrical posture and controlled movements according to NDT principles (facilitation, stimulation, communication). Dosage - 60-minute sessions, twice weekly, for 3 months.', 'armGroupLabels': ['NDT-Bobath + Sitting Exergaming', 'NDT-Bobath + Standing Exergaming']}, {'name': 'Sitting Exergaming', 'type': 'OTHER', 'otherNames': ['Seated Exergaming'], 'description': "Exergaming performed in a seated position using Kinect Therapy-Based Exergames. Participants sit on an adjustable chair with hips, knees, and ankles flexed at 90°. Exercises involve safe, non-impact, visually engaging three-dimensional trunk and limb movements, personalized to the child's functional level. Movements are synchronized with the MyoMotion system for monitoring. Dosage - 60-minute sessions, twice weekly, for 3 months (as part of combined therapy).", 'armGroupLabels': ['NDT-Bobath + Sitting Exergaming']}, {'name': 'Standing Exergaming', 'type': 'OTHER', 'description': "Exergaming performed in a standing position using Kinect Therapy-Based Exergames, promoting weight-bearing and functional trunk and limb control. Exercises involve safe, visually engaging three-dimensional movements, personalized to the child's functional abilities. Movements are synchronized with the MyoMotion system for real-time monitoring. Dosage - 60-minute sessions, twice weekly, for 3 months (as part of combined therapy).", 'armGroupLabels': ['NDT-Bobath + Standing Exergaming']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57-320', 'city': 'Polanica-Zdrój', 'state': 'Lower Silesian Voivodeship', 'country': 'Poland', 'contacts': [{'name': 'Aleksandra Kopaczyńska, Master of Science', 'role': 'CONTACT', 'email': 'aleksandra.kopaczynska@awf.wroc.pl', 'phone': '+48601157773'}, {'name': 'Aleksandra Kopaczyńska, Master of Science', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Specjalistyczne Centrum Medyczne im. Jana Pawła II S.A.', 'geoPoint': {'lat': 50.40373, 'lon': 16.51271}}, {'zip': '51-612', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'country': 'Poland', 'contacts': [{'name': 'Aleksandra Kopaczyńska, Master of Science', 'role': 'CONTACT', 'email': 'aleksandra.kopaczynska@awf.wroc.pl', 'phone': '+48601157773'}, {'name': 'Aleksandra Kopaczyńska, Master of Science', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wroclaw University of Health and Sport Sciences', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'centralContacts': [{'name': 'Aleksandra Kopaczyńska, Master of Science', 'role': 'CONTACT', 'email': 'aleksandra.kopaczynska@awf.wroc.pl', 'phone': '+48601157773'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'At this time, a final decision has not been made regarding the sharing of de-identified individual participant data (IPD). Potentially shareable data would include de-identified demographic information and outcome data relevant to the primary and secondary endpoints of the study.\n\nThe decision regarding IPD sharing will be made after completion of the study and final data analyses. This is due to the need to evaluate:\n\n* compliance with applicable data protection and privacy regulations,\n* limitations related to the informed consent obtained from participants,\n* potential contractual or institutional obligations,\n* the risk of participant re-identification despite data de-identification. Following study completion and publication of results, the possibility of sharing IPD will be reconsidered.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wroclaw University of Health and Sport Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Aleksandra Kopaczyńska', 'investigatorAffiliation': 'Wroclaw University of Health and Sport Sciences'}}}}