Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT01570920
Status:
COMPLETED
Last Update Posted:
2012-04-04
First Post:
2010-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Regular Brisk Walking in Chronic Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}], 'ancestors': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-02', 'studyFirstSubmitDate': '2010-03-30', 'studyFirstSubmitQcDate': '2012-04-02', 'lastUpdatePostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACTIVLIM-Stroke (Activity limitations measures)', 'timeFrame': '7 months', 'description': 'mainly self-reported outcomes measures'}], 'secondaryOutcomes': [{'measure': 'Stroke Impairment', 'timeFrame': '7 months', 'description': 'Stroke related impairment are assessed with specific outcomes measures (SIAS, BBS, ...).'}, {'measure': 'Walking ability', 'timeFrame': '7 months', 'description': 'Walking ability is assessed throuht walking speed and walking endurance'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Activity limitations', 'restriction of participation', 'chronic stroke survival', 'physical activity', 'walking'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '23974944', 'type': 'DERIVED', 'citation': 'Batcho CS, Stoquart G, Thonnard JL. Brisk walking can promote functional recovery in chronic stroke patients. J Rehabil Med. 2013 Sep;45(9):854-9. doi: 10.2340/16501977-1211.'}]}, 'descriptionModule': {'briefSummary': 'Chronic stroke patients (\\>6 months) fulfilling including criteria were trained during 3 months. The physical training program was based on walking.', 'detailedDescription': 'Participants had been evaluated 4 times during a long follow-up period of 7 months. Activity limitations were assessed at baseline (enrollment time point), 1 month, 4 months and 7 months later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Stroke onset \\> or = 6 months\n* Able to walk without human assistance (may use walking aid)\n* Sign informed consent form\n* Approval from physician for participation in study\n* Live in Belgium or in Benin\n\nExclusion Criteria:\n\n* cardiac history of active unstable angina, recent (less than 3 months) myocardial infarction, or congestive heart failure\n* orthopedic, circulatory, or chronic pain conditions restricting exercise;\n* dementia;\n* severe receptive or global aphasia with inability to follow 2-step commands;\n* co-morbid non-stroke neurological disorder that impairs mobility (e.g. MS or Parkinson's);"}, 'identificationModule': {'nctId': 'NCT01570920', 'briefTitle': 'Effects of Regular Brisk Walking in Chronic Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Effects of Regular Brisk Walking in Chronic Stroke Patients', 'orgStudyIdInfo': {'id': '2008/04JUIL/193'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'walking', 'description': 'a cohort of stroke patients trained during 3 month, based on walking', 'interventionNames': ['Behavioral: physical training']}], 'interventions': [{'name': 'physical training', 'type': 'BEHAVIORAL', 'description': 'walking many times a week', 'armGroupLabels': ['walking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Institut of Neuroscience (IoNS) / UCL, 5375', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Jean-Louis Thonnard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université Catholique de Louvain, Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}