Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-30 @ 5:02 PM
Study NCT ID:
NCT01041560
Status:
UNKNOWN
Last Update Posted:
2009-12-31
First Post:
2009-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscle Tone Changes in Acute Stroke According to Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-30', 'studyFirstSubmitDate': '2009-12-30', 'studyFirstSubmitQcDate': '2009-12-30', 'lastUpdatePostDateStruct': {'date': '2009-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle tone', 'timeFrame': 'Immediately after stroke, during the first week in hospital every other day, and then once a week before discharging from hospital'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': 'Immediately after stroke, during the first week in hospital every other day, and then once a week before discharging from hospital'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'Tone', 'Strength'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine connections between muscle tones, strength and function after stroke.', 'detailedDescription': 'Measurements are intended to repeat every two days in acute phase to discover possible changes in tone and strength in arm and leg muscles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Stroke patients in Middle-Finland Central hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral decline in the arm or leg muscle strength\n\nExclusion Criteria:\n\n* unwilling to take part on the trial\n* not conscious\n* no differences between muscle strength on the right and left side'}, 'identificationModule': {'nctId': 'NCT01041560', 'briefTitle': 'Muscle Tone Changes in Acute Stroke According to Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Jyväskylä Central Hospital'}, 'officialTitle': 'Muscle Tone Changes in Acute Stroke According to Brain Injury in Relation to Changes in Functioning', 'orgStudyIdInfo': {'id': 'KSKS2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stoke', 'description': 'Hemiplegia with unilateral changes in tone and muscle strength'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40740', 'city': 'Jyväskylä', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Jari Ylinen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Central Finland Health Care District', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}], 'centralContacts': [{'name': 'Jari Ylinen, MD, PhD', 'role': 'CONTACT', 'email': 'jari.ylinen@ksshp.fi', 'phone': '+358142691145'}], 'overallOfficials': [{'name': 'Jari Ylinen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Senior physician'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jyväskylä Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eurostars', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Ylinen Jari, MD, PhD', 'oldOrganization': 'Jyväskylä Central Hospital'}}}}