Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2026-01-11 @ 12:46 PM
Study NCT ID:
NCT03023150
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2017-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation - Froedtert
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019194', 'term': 'Ischemic Preconditioning'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-23', 'studyFirstSubmitDate': '2017-01-03', 'studyFirstSubmitQcDate': '2017-01-13', 'lastUpdatePostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Knee Extensor Strength', 'timeFrame': 'Admission into study and within 3 days of Discharge from Froedtert Hospital'}], 'secondaryOutcomes': [{'measure': 'Change in Walking Speed', 'timeFrame': 'Admission into study and within 3 days of Discharge from Froedtert Hospital'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke Rehabilitation', 'Ischemic Preconditioning', 'Physical and Rehabilitation Medicine']}, 'descriptionModule': {'briefSummary': 'This study will be the first study to use ischemic preconditioning (IPC) as an intervention to improve stroke rehabilitation. IPC is a well studied, well tolerated intervention which has been shown to improve regional blood flow, motor neuron excitability and muscle function in multiple patient groups and in young, healthy subjects. Because IPC targets three physiological systems which are all affected by stroke, we hypothesize that repeated bouts of IPC during the first days to months following stroke (when the majority of recovery occurs) will make traditional rehabilitation strategies more effective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. be between the ages of 40-80\n2. able to give informed consent.\n3. be \\< 6 months post diagnosis of unilateral cortical stroke and\n4. have residual leg paresis.\n\nExclusion Criteria:\n\n1. chronic low back or hip pain\n2. substance abuse\n3. head trauma with loss of conciousness in last 6 months\n4. neurodegenerative disorder\n5. participant taking any medication or supplement that adversely interacts with nitroglycerin (exclusion from nitro administration only, applies to outpatients only)\n6. participant has a known allergy to nitroglycerin (exclusion from nitro administration only, applies to outpatients only)\n7. resting systolic blood pressure \\< 90mmHg (exclusion from nitro administration only, applies to outpatients only)\n8. any condition where knee extension contractions are contraindicated\n9. people who are unable to follow multi step commands.\n10. pregnancy (DXA scan exclusion only)\n11. history of major psychiatric disorder\n12. participant has had a myocardial infarction in the last year\n13. participant has stage II hypertension (BP\\>160/100)\n14. participant is unable to contract knee muscles\n15. participant is unable to sit upright for 2 hours\n16. participant has a resting heart rate \\>100 beats per minute\n17. history of multiple strokes'}, 'identificationModule': {'nctId': 'NCT03023150', 'briefTitle': 'Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation - Froedtert', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation', 'orgStudyIdInfo': {'id': 'PRO00027450'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ischemic Preconditioning', 'description': 'Inflation of blood pressure cuff to 225 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times.', 'interventionNames': ['Other: Ischemic Preconditioning']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'Inflation of blood pressure cuff to 25 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times.', 'interventionNames': ['Other: Sham']}], 'interventions': [{'name': 'Ischemic Preconditioning', 'type': 'OTHER', 'armGroupLabels': ['Ischemic Preconditioning']}, {'name': 'Sham', 'type': 'OTHER', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Marquette University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Matthew J. Durand', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}