Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-31 @ 1:47 PM
Study NCT ID:
NCT06454656
Status:
RECRUITING
Last Update Posted:
2024-08-21
First Post:
2024-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Motor Learning Intervention to Target Walking Performance in Ambulant Children With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D051346', 'term': 'Mobility Limitation'}], '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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Feasibility Study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2024-05-24', 'studyFirstSubmitQcDate': '2024-06-06', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment Rate', 'timeFrame': 'rolling recruitment over 1.5 years', 'description': 'Percentage of eligible numbers recruited'}, {'measure': 'Adherence to Intervention', 'timeFrame': 'Duration of study 2 years', 'description': 'Percentage of total hours practiced/ planned dose (30 hours)'}, {'measure': 'Retention', 'timeFrame': 'Duration of study 2 years', 'description': 'Percentage of recruited participants at final follow up'}, {'measure': 'Adverse Events', 'timeFrame': 'Duration of study 2 years', 'description': 'Measured as Yes or No with description'}, {'measure': 'Fidelity to Intervention Protocol', 'timeFrame': 'Duration of study 2 years', 'description': 'Checklist to measure extent of motor learning principles included in sessions'}, {'measure': 'Feasibility of Outcome Measures (Participant)', 'timeFrame': 'Duration of study 2 years', 'description': 'Participant experience of outcomes captured by semi-structured interviews.'}, {'measure': 'Feasibility of Outcome Measures (Assessor)', 'timeFrame': 'Duration of study 2 years', 'description': 'Assessor experience of outcomes captured by semi-structured interview.'}, {'measure': 'Acceptability of Intervention', 'timeFrame': 'Duration of study 2 years', 'description': 'Semi-structured interviews of participants and parents to capture acceptability of intervention using Framework of acceptability'}, {'measure': 'Time taken to complete Outcome Measures', 'timeFrame': 'Duration of study 2 years', 'description': 'Measured in Minutes'}], 'secondaryOutcomes': [{'measure': 'Gait Outcome Assessment List', 'timeFrame': 'baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years', 'description': 'parent/self-report questionnaire developed to measure functional mobility and goals for ambulant children with CP. This measure will be used to power a future definitive trial.'}, {'measure': '6 minute walk test', 'timeFrame': 'baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years', 'description': 'This is a measure of gait endurance and has been validated for use in CP. Gait speed will also be calculated using this measure.'}, {'measure': '10 meter self-selected walking speed', 'timeFrame': 'baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years', 'description': 'habitual walking speed selected as it correlates well with habitual physical activities.'}, {'measure': 'Modified timed up and go', 'timeFrame': 'baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years', 'description': 'tests balance and basic mobility in children with physical disabilities and has been validated for use in CP'}, {'measure': 'ankle and knee Range of motion', 'timeFrame': 'baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years', 'description': 'CPIP measures of ankle DF and popliteal angle'}, {'measure': 'Child Health Utilities Index CHU-9D', 'timeFrame': 'baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years', 'description': 'self-report measure that can calculate quality adjusted life years to measure quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Motor Learning Theory', 'Neuroplasticity', 'Neurological Rehabilitation'], 'conditions': ['Cerebral Palsy', 'Walking, Difficulty', 'Spastic Diplegia', 'Hemiplegic Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if a new therapy approach to improve walking ability in children with Cerebral Palsy is acceptable to the children and the families in a community setting.\n\nThe main questions we look to answer are:\n\n1. Do the children/teens tolerate the therapy and feel that it is helpful?\n2. Do the parents/ families feel the therapy helps and is easy to commit to?\n3. Do the children/teens complete all their therapy sessions and assessments as planned?\n\nThe participants will trial the therapy for 30 hours over 6 weeks and will perform assessments before and after to see if they meet their goals. They will also be interviewed to see how they felt about the therapy when they finish.', 'detailedDescription': "The therapy being trialed in this study uses motor learning theory to try and improve or change walking patterns to improve the child/teen's walking goal.\n\nTherapy will target their own walking goal and they can choose the format of their therapy as long as they complete 30 hours of which 24 hours must be in the clinic within a 6 week period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of Cerebral Palsy (GMFCS Levels I-III)\n* Has a specific walking related goal\n* Has capacity to follow instruction\n* Has a primary caregiver who can support a home program\n\nExclusion Criteria:\n\n* Has had surgery within 6 months of intervention start date\n* Has had botox/ baclofen within 3 months of intervention start date\n* Has a dual diagnosis that impacts ability to follow instruction\n* Has a significant cognitive impairment'}, 'identificationModule': {'nctId': 'NCT06454656', 'acronym': 'MOBILE', 'briefTitle': 'A Motor Learning Intervention to Target Walking Performance in Ambulant Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Royal College of Surgeons, Ireland'}, 'officialTitle': 'A "MOtor Learning Based Intervention for Lower Extremities (MOBILE)" to Target Walking Performance in Ambulant Children With Cerebral Palsy: A Feasibility Study', 'orgStudyIdInfo': {'id': '23-163'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants will undergo 30 hours of therapy over 6 weeks in format of their choosing.\n\nA minimum of 24 hours must be completed in clinic with the rest made up of home program.', 'interventionNames': ['Other: MOBILE']}], 'interventions': [{'name': 'MOBILE', 'type': 'OTHER', 'otherNames': ['MOtor learning Based Intervention for Lower Extremities'], 'description': 'Intensive motor learning based intervention to target specific walking goals as identified using the Gait Outcome Assessment List.\n\nFull Protocol outlining strategies available on request.\n\nThree key principles underpin the intervention:\n\nPrinciple 1: The type of task\n\nPrinciple 2: The type of practice\n\nPrinciple 3: The type of Feedback', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C15K0FV', 'city': 'Balrath', 'state': 'Meath', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': "Caitriona M O'Shaughnessy, BSc", 'role': 'CONTACT', 'email': 'caitrionaoshaug22@rcsi.com', 'phone': '0833128927'}, {'name': 'Lorna Gough, BA Hons', 'role': 'CONTACT', 'email': 'lgough@enableireland.ie', 'phone': '01 8240696'}], 'facility': 'Enable Ireland Bangla Therapy Centre', 'geoPoint': {'lat': 53.62472, 'lon': -6.48806}}], 'centralContacts': [{'name': "Caitriona M O'Shaughnessy", 'role': 'CONTACT', 'email': 'caitrionaoshaug22@rcsi.com', 'phone': '0833128927'}, {'name': 'Ailish Malone, PHD', 'role': 'CONTACT', 'email': 'ailishmalone@rcsi.ie', 'phone': '+3531-4022392'}], 'overallOfficials': [{'name': 'Ailish Malone, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal College of Surgeons'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal College of Surgeons, Ireland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professional Doctorate Scholar', 'investigatorFullName': "Catriona O'Shaughnessy", 'investigatorAffiliation': 'Royal College of Surgeons, Ireland'}}}}