Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-02-22 @ 8:52 AM
Study NCT ID:
NCT03674268
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2018-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psycometric Properties of Pushing Scale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2018-09-14', 'studyFirstSubmitQcDate': '2018-09-14', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contraversive Pushing Scale score', 'timeFrame': '4 weeks', 'description': 'Scale of evaluation of trunk control and pushing behavior in patients with stroke.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Balance', 'Functionality']}, 'descriptionModule': {'briefSummary': 'Psycometric properties of a scale', 'detailedDescription': 'After a period of training in the administration of the CPS, a pilot will be conducted with 10 patients who meet the inclusion-exclusion criteria and after signing the informed consent document, in which the 4 researchers will administer the CPS during two sessions on consecutive days, with the objective of evaluating the test-retest and intra-observer reliability, minimize the differences of criteria in its application and, if necessary, write an instruction manual.\n\nOnce each patient has signed the informed consent document and it has been verified that the inclusion criteria are met, it will be assigned an Identification Number (ID) that will relate it to your Medical Record (IDHC) by simple coding; The custody of the file with the relation of each ID with its HC will be borne by the principal investigator. Likewise, each observer will be assigned an identification number in order to blind the researcher who performs the statistical analysis. The patients included in the study will be evaluated, through the Spanish version of the CPS, by two of the researchers with an interval of 10 minutes between each evaluation, repeating this same procedure the next day. These evaluation sessions will be carried out throughout the treatment period, repeating on days 1, 15 and 28 of the period of admission of the included patients. Two researchers will evaluate the patients treated in the morning shift and the other two those treated in the afternoon shift of the Physiotherapy Service of the Guadarrama Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with the diagnosis of stroke who enter the Guadarrama Hospital, meet the inclusion / exclusion criteria and agree to participate in the study after signing the informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must understand and voluntarily sign the corresponding informed consents and information sheet before any evaluation / procedure related to the study is conducted.\n* Male or female, ≥18 years of age at the time of consent.\n* Have the diagnosis of ischemic or hemorrhagic hemispheric stroke without excluding other causes (surgery, cancer, etc ...).\n* Enter for the first time in the Guadarrama Hospital to receive physiotherapy treatment.\n\nExclusion Criteria:\n\n* A patient can not be recruited in this study if they have severe cognitive impairment, moderate-severe language problems, or severe vision or hearing deficits that prevent compression and active collaboration during evaluation tests.'}, 'identificationModule': {'nctId': 'NCT03674268', 'briefTitle': 'Psycometric Properties of Pushing Scale', 'organization': {'class': 'OTHER', 'fullName': 'Guadarrama Hospital'}, 'officialTitle': 'Psychometric Properties of the Spanish Version of the Contraversive Pushing Scale', 'orgStudyIdInfo': {'id': '4.0'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Management of the Contraversive Pushing Scale', 'type': 'DIAGNOSTIC_TEST', 'description': 'Scale of evaluation of trunk control and pushing behavior in patients with stroke.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28440', 'city': 'Guadarrama', 'state': 'Madrid', 'country': 'Spain', 'facility': 'J.Nicolas Cuenca Zaldivar', 'geoPoint': {'lat': 40.6727, 'lon': -4.08949}}], 'overallOfficials': [{'name': 'J.Nicolas Cuenca Zaldivar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guadarrama Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ANALYTIC_CODE'], 'timeFrame': 'The data will be available permanently once the statistical analysis is complete.', 'ipdSharing': 'YES', 'description': 'The statistical analysis plan and the analytical code will be available in .html and .rmd format as well as the file with the raw data.', 'accessCriteria': 'The data will be available freely and publicly.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guadarrama Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Francisco de Vitoria', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rehabilitation Service Principal Investigator', 'investigatorFullName': 'J. Nicolas Cuenca Zaldivar', 'investigatorAffiliation': 'Guadarrama Hospital'}}}}