Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT02666469
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2015-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HBOT Global Functioning After Stroke
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}, {'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-12', 'studyFirstSubmitDate': '2015-11-30', 'studyFirstSubmitQcDate': '2016-01-24', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number or participants finishing the trial', 'timeFrame': '8 weeks', 'description': 'The number of patients finishing the trial'}], 'secondaryOutcomes': [{'measure': 'Total time spent doing rehabilitation exercise', 'timeFrame': '8 weeks', 'description': 'Total time spent engaging in rehabilitation exercise (GRASP) in the trial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hyperbaric oxygen treatment, rehabilitation'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '32574506', 'type': 'DERIVED', 'citation': 'Schiavo S, Richardson D, Santa Mina D, Buryk-Iggers S, Uehling J, Carroll J, Clarke H, Djaiani C, Gershinsky M, Katznelson R. Hyperbaric oxygen and focused rehabilitation program: a feasibility study in improving upper limb motor function after stroke. Appl Physiol Nutr Metab. 2020 Dec;45(12):1345-1352. doi: 10.1139/apnm-2020-0124. Epub 2020 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'Stroke is one of the leading causes of disability and death in North America and Europe. Up to 30% of stroke survivors never recuperate completely and suffer from loss of function and poor quality of life. To improve recovery after stroke, innovative interventions should be a priority.\n\nHyperbaric oxygen therapy (HBOT) is an intermittent inhalation of 100% oxygen in a hyperbaric chamber at a pressure higher than 1 absolute atmosphere (ATA). There is a growing body of evidence that HBOT can enhance ability of brain to changes its structure (neuroplasticity) in order to recover. Exercise program during HBOT can augment the effect. Although, recent randomized controlled trials in patients with chronic brain injury showed promising results, there are no studies demonstrating combine effect HBOT and exercise rehabilitation program on stroke recovery.\n\nThe proposed study investigates feasibility, safety and efficacy of using a combination of HBOT and exercise program to improve arm function recovery in chronic stroke patients. In this pilot randomized control trial, investigators will compare the combination of HBOT and the focused rehabilitation exercise program versus exercise program alone on recovery of arm function in patients with chronic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* history of ischemic or hemorrhagic stroke 6-48 months confirmed by CT\n* arm hemiparesis/hemiplegia\n* Chedoke-McMaster Stroke Assessment Scale 3-6\n* ability to follow verbal commands\n\nExclusion Criteria:\n\n* women with positive pregnancy test or plans to become pregnant during the study period\n* severe cognitive dysfunction (The Mini Mental State Examination \\<24 )\n* claustrophobia\n* seizure disorder\n* active asthma\n* severe chronic obstructive pulmonary disease\n* history of spontaneous pneumothorax\n* history of severe congestive heart failure with left ventricular ejection fraction \\< 30%; unstable angina\n* myocardial infarction (within the last 3 months)\n* chronic sinusitis\n* chronic acute otitis media or major ear drum trauma\n* current treatment with bleomycin, cisplatin, doxorubicin and disulfiram\n* participation in another investigative drug or device trial currently or within the last 30 days'}, 'identificationModule': {'nctId': 'NCT02666469', 'briefTitle': 'HBOT Global Functioning After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Hyperbaric Oxygen and Focused Rehabilitation Program: A Feasibility Study in Improving Global Functioning After Stroke', 'orgStudyIdInfo': {'id': '15-8834-D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A Hyperbaric Oxygen Therapy and Exercise Program', 'description': 'Group A: Hyperbaric Oxygen Therapy (HBOT) and Exercise with HBOT sessions for 90 minutes, once daily, 5 times a week for 8 consecutive weeks. HBOT will be provided with 100% oxygen at 2.0 ATA. Patients will exercise in the multiplace hyperbaric chamber while receiving hyperbaric oxygen.', 'interventionNames': ['Other: Hyperbaric Oxygen Therapy (HBOT) and Exercise Program', 'Other: Exercise Program', 'Device: Hyperbaric Multiplace Chamber']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B Exercise Program', 'description': 'Group B: Exercise Program in the hyperbaric medical unit without exposure to HBOT', 'interventionNames': ['Other: Exercise Program']}], 'interventions': [{'name': 'Hyperbaric Oxygen Therapy (HBOT) and Exercise Program', 'type': 'OTHER', 'description': 'HBOT provided with 100% oxygen at 2.0 ATA and rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)', 'armGroupLabels': ['Group A Hyperbaric Oxygen Therapy and Exercise Program']}, {'name': 'Exercise Program', 'type': 'OTHER', 'description': 'Rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)', 'armGroupLabels': ['Group A Hyperbaric Oxygen Therapy and Exercise Program', 'Group B Exercise Program']}, {'name': 'Hyperbaric Multiplace Chamber', 'type': 'DEVICE', 'description': 'Patients will receive treatment in a multiplace Hyperbaric Chamber', 'armGroupLabels': ['Group A Hyperbaric Oxygen Therapy and Exercise Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital, University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Rita Katznelson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}, {'name': 'Denyse Richardson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto Rehabilitation Institute, UHN'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Manager Anesthesia Research', 'investigatorFullName': 'Jo Carroll', 'investigatorAffiliation': 'University Health Network, Toronto'}}}}