Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-08 @ 11:00 PM
Study NCT ID:
NCT04091594
Status:
WITHDRAWN
Last Update Posted:
2020-12-08
First Post:
2019-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Effects of Sensory Input Orthotics in Disorders of Posture and Movement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Insufficient funding was available and the study could not be started.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-04', 'studyFirstSubmitDate': '2019-09-13', 'studyFirstSubmitQcDate': '2019-09-13', 'lastUpdatePostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in perceived psychosocial well-being - parents', 'timeFrame': 'Baseline to 2 months', 'description': "Participant's parents will complete the Pediatric Evaluation of Disabilities Inventory (PEDI)"}, {'measure': 'Change in perceived psychosocial well-being - children', 'timeFrame': 'Baseline to 2 months', 'description': 'Children ages 9 and up will be administered the Psychosocial Impact of Assistive Device Survey (PIADS) by a trained clinician'}, {'measure': 'Change in gross motor function', 'timeFrame': 'Baseline to 2 months', 'description': 'A trained physical therapist will administer the global gross motor function (GMFM-88) assessment'}, {'measure': 'Change in lower extremity kinematics and posture stability', 'timeFrame': 'Baseline to 2 months', 'description': 'Participants will perform a 10 second walk test in the Motor Control Lab while being recorded with a Vicon 3D motion capture system.'}, {'measure': 'Change in balance', 'timeFrame': 'Baseline to 2 months', 'description': 'Participants will perform the 14-point items of the Pediatric Balance Scale in the Motor Control Lab while being recorded with a Vicon 3D motion capture system.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to use tools for measuring function and movement in pediatric populations to measure the impact of input orthotic interventions in children with cerebral palsy.', 'detailedDescription': 'Sensory processing begets movement. In persons with disorders of posture and movement due to cerebral palsy, an impaired ability to integrate multiple senses including pressure from ground, limb proprioception, and vestibular inputs leads to a movement pattern that is coarse, spastic and inefficient. In the pediatric rehab clinic spastic movement disorders have been treated with flexible, molded orthotics for the foot and ankle (AFO) to enhance sensation of ground reaction forces, and flexible elastomeric compression garments to enhance body and limb proprioception. While the investigators observed substantial improvements in gait quality and postural stability using sensory input orthotics, these clinical observations have not been objectively quantified. The goal is to use validated tools for measuring function and movement in pediatric populations in order to gather data on the value of sensory input orthotic interventions in children with cerebral palsy.\n\nUnder the term, sensory input orthotic, the following items are included which will be used in this study. 1) A flexible, thin polypropylene shell ankle-foot orthotic designed according to Hylton et al. Journal of P\\&O 1989. 2) Wearable elastomeric compression garments manufactured by SPIO or from the Boston Brace DMO garment line. 3) A vibrating anklet that provides subsensory vibrational stimulation to the leg, manufactured by Accelera.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cerebral palsy\n* Ages 6 months to 21 years\n* No prior prescription of sensory input ankle-foot orthotics\n* Clinical diagnosis of abnormal gait and mobility\n\nExclusion Criteria:\n\n• Joint contracture that severely limits function such as ability to passively open the hand, extend the arm at the elbow or to stand with feet flat on the ground or knees in an extended position.'}, 'identificationModule': {'nctId': 'NCT04091594', 'briefTitle': 'Investigating the Effects of Sensory Input Orthotics in Disorders of Posture and Movement', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Investigating the Effects of Sensory Input Orthotics in Disorders of Posture and Movement', 'orgStudyIdInfo': {'id': 'HM20015260'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flexible orthotic', 'description': 'Sensory input flexible ankle foot orthotic (SIAFO) with appropriate lycra garments', 'interventionNames': ['Device: Flexible orthotic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care', 'description': 'Standard of care solid ankle foot orthotic (AFO)', 'interventionNames': ['Device: Standard orthotic']}], 'interventions': [{'name': 'Flexible orthotic', 'type': 'DEVICE', 'description': 'Participants will receive the SIAFO to wear', 'armGroupLabels': ['Flexible orthotic']}, {'name': 'Standard orthotic', 'type': 'DEVICE', 'description': 'Participants will received the standard AFO to wear', 'armGroupLabels': ['Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Olivier Rolin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}