Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT04293120
Status:
TERMINATED
Last Update Posted:
2021-06-01
First Post:
2020-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Training Balance Among People With Neurodevelopmental Disabilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-11-13', 'releaseDate': '2025-10-30'}, {'resetDate': '2025-11-26', 'releaseDate': '2025-11-13'}], 'estimatedResultsFirstSubmitDate': '2025-10-30'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D004314', 'term': 'Down Syndrome'}], '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': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Case control, matched on gender, age, and BMI'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'COVID restrictions prevented recruitmetn', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-26', 'studyFirstSubmitDate': '2020-02-10', 'studyFirstSubmitQcDate': '2020-03-02', 'lastUpdatePostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle activation timing', 'timeFrame': 'Pre-intervention muscle activation timing will be assessed on the initial visit. Post-intervention muscle activation timing will be assessed immediately after the fourth training session, at most, 7 days later.', 'description': 'Evaluation in change in muscle activation timing of anterior tibialis, soleus, gastroc, rectus femoris, biceps femoris, rectus abdominis using electromyography'}], 'secondaryOutcomes': [{'measure': 'Muscle amplitude response', 'timeFrame': 'Pre-intervention muscle amplitude response will be assessed on the initial visit. Post-intervention muscle amplitude response will be assessed immediately after the fourth training session, at most, 7 days later.', 'description': 'Evaluation in change in amplitude of anterior tibialis, soleus, gastroc, rectus femoris, biceps femoris, rectus abdominis using electromyography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Posture', 'Balance', 'Cerebral Palsy', 'Autism', 'Down Syndrome']}, 'descriptionModule': {'briefSummary': 'This study is a case control pilot study to investigate the impact of a short-term intervention on training anticipatory postural adjustments in a population of people with neurodevelopmental disabilities.', 'detailedDescription': "Data will be collected by using a weighted pendulum to provide a posterior perturbation to test subjects' postural reactions pre and post-intervention. Intervention will include four sessions of weighted ball tosses/weighted tether ball stops to improve muscle activation patterns and efficiency. EMG sensors, 3D motion analysis, and force plates will be used to collect the necessary data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants\n\n1. Able to stand without assistance\n2. Diagnosis of cerebral palsy, Down Syndrome, or Autism Spectrum Disorder\n3. Able to stop weighted ball without falling\n4. Able to follow directions\n\nControls\n\n1. Able to stand without assistance\n2. No neurodeveloopmental disability\n3. Able to stop weighted ball without falling\n4. Able to follow directions\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Unable to maintain standing when stopping a ball on a rope'}, 'identificationModule': {'nctId': 'NCT04293120', 'acronym': 'TAPAS', 'briefTitle': 'Training Balance Among People With Neurodevelopmental Disabilities', 'organization': {'class': 'OTHER', 'fullName': 'University of Hartford'}, 'officialTitle': 'Training Anticipatory Postural Adjustments Among People With Neurodevelopmental Disabilities', 'orgStudyIdInfo': {'id': 'PRO19020012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training', 'description': 'Training 4 sessions over a one week time period of 180 catches/stops with a medicine ball.', 'interventionNames': ['Other: Training with weighted ball']}], 'interventions': [{'name': 'Training with weighted ball', 'type': 'OTHER', 'description': 'Participants will stop or catch a weighted ball', 'armGroupLabels': ['Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06117', 'city': 'West Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Hartford', 'geoPoint': {'lat': 41.76204, 'lon': -72.74204}}], 'overallOfficials': [{'name': 'Mary E Gannotti, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Hartford'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hartford', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universita di Verona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mary Gannotti', 'investigatorAffiliation': 'University of Hartford'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-10-30', 'type': 'RELEASE'}, {'date': '2025-11-13', 'type': 'RESET'}, {'date': '2025-11-13', 'type': 'RELEASE'}, {'date': '2025-11-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mary Gannotti, Professor, University of Hartford'}}}}