Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2025-12-30 @ 1:07 AM
Study NCT ID:
NCT01911559
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2013-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D011782', 'term': 'Quadriplegia'}, {'id': 'D003248', 'term': 'Constipation'}], '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': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-16', 'studyFirstSubmitDate': '2013-07-19', 'studyFirstSubmitQcDate': '2013-07-29', 'lastUpdatePostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'pain related to the bowel evacuation', 'timeFrame': '14 weeks', 'description': 'Using a daily-diary where the caregivers collect the data about the pain related to the bowel evacuation'}, {'measure': 'distress of the caregiver', 'timeFrame': '14 weeks', 'description': 'Using a daily-diary where the caregivers collect the data about the distress of the caregiver'}], 'primaryOutcomes': [{'measure': 'bowel evacuation frequency', 'timeFrame': '14 weeks', 'description': 'Using a daily-diary where the caregivers collect the data about the bowel evacuation frequency'}], 'secondaryOutcomes': [{'measure': 'Bowel evacuation inductions frequency', 'timeFrame': '14 weeks', 'description': 'Using a daily-diary where the caregivers collect the data about the bowel evacuation inductions frequency'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Standing-frame', 'Chronic constipation', 'Cerebral palsy', 'Quadriplegia', 'Severe diplegia'], 'conditions': ['Cerebral Palsy', 'Quadriplegia', 'Diplegia', 'Constipation']}, 'referencesModule': {'availIpds': [{'id': '9433361', 'url': 'http://www.biomedsearch.com/nih/Effectiveness-Standing-Frame-Constipation-in/24838311.html', 'type': 'Clinical Study Report', 'comment': 'Rivi, Elena \\& Filippi, Mariacristina \\& Fornasari, Elisa \\& Mascia, Maria Teresa \\& Ferrari, Adriano \\& Costi, Stefania. (2014). Effectiveness of Standing Frame on Constipation in Children with Cerebral Palsy: A Single-Subject Study. Occupational therapy international.'}], 'references': [{'pmid': '17304099', 'type': 'BACKGROUND', 'citation': 'Pin TW. Effectiveness of static weight-bearing exercises in children with cerebral palsy. Pediatr Phys Ther. 2007 Spring;19(1):62-73. doi: 10.1097/PEP.0b013e3180302111.'}]}, 'descriptionModule': {'briefSummary': 'Children with Cerebral Palsy and quadriplegia or severe diplegia suffer from highly reduced mobility and consequent constipation. Clinicians frequently recommend standing-frames to exercise the support reaction in this population, sharing the opinion that the upright position may facilitate intestinal transit, although no evidence supports this assumption.\n\nThe investigators conducted this single-subject research to determine the effects of the standing-frame on the frequency of evacuation in chronically constipated children with CP and quadriplegia.\n\nMoreover, the investigators studied its effects on the frequency of induction of evacuation, the characteristics of the stool and the pain suffered by the child due to constipation and/or evacuation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In this study we included children with CP, in the manifestation of severe diplegia or quadriplegia, who do not currently use the standing-frame. The population of interest might be referred to the Unit for severe disability in developmental age or to one of the neuro-psychiatric and rehabilitation Units of the area of Modena and Reggio Emilia, (5.000 km2 of surface and 1.250.000 inhabitants)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria were:\n\n* clinical indication for the use of the standing-frame;\n* constipation problems as defined by guidelines (Clinical Practice Guideline, 2006);\n* whose parents gave the informed consent to let their child to participate in this study.\n\nExclusion criteria were:\n\n* children who have orthosympathetic reactions to the upright position, skeletal deformities and/or medical conditions that, according to clinical judgment, advise against the use of the standing frame.'}, 'identificationModule': {'nctId': 'NCT01911559', 'acronym': 'CP', 'briefTitle': 'Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'University of Modena and Reggio Emilia'}, 'officialTitle': 'Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy: a Single Subject Study', 'orgStudyIdInfo': {'id': 'standing_2013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'constipated quadriplegic CP children', 'description': 'In this study we included children with CP, in the manifestation of severe diplegia or quadriplegia, who do not currently use the standing-frame.', 'interventionNames': ['Device: standing-frame']}], 'interventions': [{'name': 'standing-frame', 'type': 'DEVICE', 'otherNames': ['stander'], 'armGroupLabels': ['constipated quadriplegic CP children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41124', 'city': 'Carpi', 'state': 'Modena', 'country': 'Italy', 'facility': 'Local Health Institution of Modena', 'geoPoint': {'lat': 44.78237, 'lon': 10.8777}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stefania Costi', 'class': 'OTHER'}, 'collaborators': [{'name': "Azienda Unita' Sanitaria Locale Di Modena", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MSc in PT', 'investigatorFullName': 'Stefania Costi', 'investigatorAffiliation': 'University of Modena and Reggio Emilia'}}}}