Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-01 @ 12:31 PM
Study NCT ID:
NCT03352232
Status:
COMPLETED
Last Update Posted:
2021-12-21
First Post:
2017-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperbaric Oxygen and Manipulative Therapies to Regain Function Post Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D000083242', 'term': 'Ischemic 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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There will be two populations based on when they experienced a stroke. Subacute stroke patients will have suffered an ischemic stroke within 3 months of enrollment and have persistent neurological deficits. The second group will be patients who suffered an ischemic stroke more than 6 months (chronic) from time of enrollment and have persistent neurological deficits compromising activities of daily living.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-20', 'studyFirstSubmitDate': '2017-11-14', 'studyFirstSubmitQcDate': '2017-11-21', 'lastUpdatePostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'National Institute of Health Stroke Score (NIHSS) 0-5 or Modified Rankin Score (mRS) 0-2', 'timeFrame': '90 Days', 'description': 'Primary Outcome NIHSS 0-5, 0 without deficits; mRS 0-2, 0 without disability - 2 slight disability, no need for assistance'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory', 'timeFrame': '90 days', 'description': 'assessment of Depression scale rating'}, {'measure': 'Wolf Motor Score', 'timeFrame': '90 days', 'description': 'assessment of functional motor recovery'}, {'measure': 'Rivermead Extended Activities of Daily Living (EADL) scale', 'timeFrame': '90 days', 'description': 'assessment of capability navigating usual and community based ADLs'}, {'measure': 'Medical Outcomes 36 Item', 'timeFrame': '90 days', 'description': 'assessment of global health'}, {'measure': 'Functional Independence Measure (FIM)', 'timeFrame': '90 days', 'description': "universally used assessment of patient's ability to perform activities of daily living"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Motor Dysfunction', 'Chronic Stroke', 'Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'To study safety, feasibility and outcomes of combining osteopathic manipulative therapies with hyperbaric oxygen therapy in reducing the functional deficits in stroke survivors in subacute and chronic phases post ischemic stroke. To document the same as part of a pilot project in anticipation of further investigational studies.', 'detailedDescription': 'The primary objective of this study is to show that hyperbaric oxygen therapy combined with osteopathic manipulative therapies improve outcomes in patients who have persistent neurological deficits after ischemic stroke compared to historical norms.\n\nThe secondary objectives of this study is to demonstrate safety and feasibility of treating patients post stroke with hyperbaric oxygen and osteopathic therapies as well as determine improvements in multiple assessment scales of motor function, depression, activities of daily living(ADL) and pain'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Post Ischemic stroke\n2. Patients aged 18-80\n3. NIHSS \\>5\n4. mRS\\>/=3, which connotes moderate disability requiring some help.\n5. Persistent significant motor dysfunction of at least one arm\n6. Subacute stroke patients (within three months from time of stroke)\n7. Chronic stroke patients (more than 6months from time of stroke)\n8. Patient must be able to understand instructions and verbalize discomfort\n9. Reliable attendance for daily (M-F) HBOT treatment and 2x/week OMT sessions for up to 6weeks\n\nExclusion Criteria:\n\n1. Hemorrhagic stroke\n2. Prior functional disability mRS \\>1\n3. Expressive or receptive aphasia\n4. Bedbound patients due to lifting limitations for HBOT\n5. History of severe, advanced emphysema with bullous disease\n6. Prior history of spontaneous pneumothorax or chest surgery\n7. Prior history of depression requiring medications\n8. Pregnancy\n9. Concomitant non-conventional rehab therapies including: acupuncture, botulinum toxin injections, massage therapy\n10. Significant claustrophobia'}, 'identificationModule': {'nctId': 'NCT03352232', 'acronym': 'HBOT/OMT', 'briefTitle': 'Hyperbaric Oxygen and Manipulative Therapies to Regain Function Post Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Abington Memorial Hospital'}, 'officialTitle': 'Oxygenating the Potential: Hyperbaric Oxygen and Manipulative Therapies to Regain Function in Stroke Survivors', 'orgStudyIdInfo': {'id': '14-063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subacute Ischemic Stroke', 'description': 'Subacute stroke patients post stroke within 3 months of enrollment, have persistent neurological deficits despite conventional rehabilitation', 'interventionNames': ['Combination Product: HBOT and OMT']}, {'type': 'EXPERIMENTAL', 'label': 'Chronic Ischemic Stroke', 'description': 'Chronic stroke patients more than 6 months from stroke with persistent neurological deficits despite conventional rehabilitation', 'interventionNames': ['Combination Product: HBOT and OMT']}], 'interventions': [{'name': 'HBOT and OMT', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Osteopathic manipulative therapies (OMT)', 'Hyperbaric Oxygen Therapy (HBOT)'], 'description': 'Hyperbaric oxygen therapy (HBOT) is defined as breathing 100% oxygen at increased atmospheric pressure. Osteopathic manipulative therapy (OMT) is used for myriad ailments including contractures, pain, spasticity. Patients in intervention arms will receive hyperbaric oxygen therapy at 2ATM (atmospheres) for 90minutes daily for up to 6weeks. In addition, they will receive osteopathic manipulative therapies twice a week during the same treatment phase.', 'armGroupLabels': ['Chronic Ischemic Stroke', 'Subacute Ischemic Stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19001', 'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Memorial Hospital', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}], 'overallOfficials': [{'name': 'Hana Choe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abington Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abington Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philadelphia College of Osteopathic Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Director NeuroIntervention and Neurocritical Care', 'investigatorFullName': 'Hana Choe', 'investigatorAffiliation': 'Abington Memorial Hospital'}}}}