Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 8:35 PM
Study NCT ID:
NCT07374432
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-28
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Full Speed Ahead: For Joyful Movement and Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Singel subject design with 3 baseline before intervention and 3 follow up after intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-25', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2026-01-25', 'lastUpdatePostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Functional mobility scale (FMS)', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': 'Measure childrens ability to walk on a 5 graded scale'}, {'measure': 'Pediatric Evaluation of the Disability Inventory (PEDI- CAT)', 'timeFrame': 'From enrollment to the end of treatment at 3 month', 'description': 'Mobility module measure childrens ability to move in the environment on a 0-100 scale'}, {'measure': 'Time up and Go (TUG)', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': 'Measure balans in standing and motion, mesaure in seconds'}, {'measure': 'Goal Attainment scale (GAS)', 'timeFrame': 'From enrollment to the end of treatment at 3 month', 'description': 'Measure individualized goals, based a a 5-graded scale'}, {'measure': 'Ultra sound', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': 'Measure the muscles thickness and form'}, {'measure': 'Pediatrice Rehabilitation Intervention Measure of Engagement for Parents (Prime P)', 'timeFrame': 'From enrollment to the end of treatment at 3 month', 'description': 'Descrieb the parents engagement in treatment'}, {'measure': 'Service Provider-Rated Measure of Client Engagement (Prime SP)', 'timeFrame': 'From enrollment to the end of treatment at 3 month', 'description': "Describe the therapist's assessment of the child's engagement"}, {'measure': 'Wrist-worn heart rate monitor', 'timeFrame': 'From enrollment to the end of treatment at 3 weeks', 'description': 'Measure the pulse continously during certain period'}], 'primaryOutcomes': [{'measure': 'Gross Motor Function MEasure (GMFM)', 'timeFrame': 'From enrollment to the end of treatment at 3 month', 'description': 'Measure gross motor function in children with CP from 6 month to 18 years, the scale ranging from 0-100 units, higher is better'}], 'secondaryOutcomes': [{'measure': 'Sens motion, Accelerometry', 'timeFrame': 'From enrollment to the end of intervention at 3 months', 'description': 'Measure physical activity in daily life'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cerebral palsy', 'Frame running', 'early intervention', 'children', 'mobility', 'physical activity'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to implement and evaluate the effects of a mobility-focused training program, including the use of running frames, on gross motor function and physical activity levels in children aged 2-5 years with cerebral palsy. The hypothesis is that these children can improve their mobility with or without assistive devices, that the training program will influence their overall activity level, and that it will provide cardiovascular exercise leading to improved fitness and muscle development.\n\nIn previous studies, the investigators have observed positive health-related outcomes in older children. Recently, three-wheeled Frame Running bikes designed for very young children have become available; however, no research has been conducted on these devices or their potential effects in toddlers.\n\nIn this project, group training sessions will be offered to children aged 2-5 years. Participants will receive mobility and gait training with or without assistive devices, depending on individual needs. The three-wheeled Frame Running bike will be included as one training component, although participants may use other assistive aids as needed. Training is planned as play-based activities together with peers, for one hour per week over a 12-week period, complemented by home-based exercises.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGMFCS II-V\n\nExclusion Criteria:\n\nsevere intelectual disability'}, 'identificationModule': {'nctId': 'NCT07374432', 'acronym': 'fullspeed', 'briefTitle': 'Full Speed Ahead: For Joyful Movement and Health', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Full Speed Ahead: For Joyful Movement and Health', 'orgStudyIdInfo': {'id': 'Dnr 2024-05809-01'}, 'secondaryIdInfos': [{'id': 'Privat donations 3 500 000 SEK', 'type': 'OTHER', 'domain': 'Karolinska Institutet'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'Frame running and gross motor training', 'interventionNames': ['Behavioral: Full speed ahead']}], 'interventions': [{'name': 'Full speed ahead', 'type': 'BEHAVIORAL', 'description': '12 weeks of daily training at home and 1 group training session /week including both Frame running and grossmotor training', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': "Department of Woman's and Children's health", 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Patient data and we need to know more about the result'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Stockholm', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, PhD', 'investigatorFullName': 'Ann-Christin Eliasson', 'investigatorAffiliation': 'Karolinska Institutet'}}}}