Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2015-10-31
2018-12-31
Brief Summary
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Hyperbaric 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.
The 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A Hyperbaric Oxygen Therapy and Exercise Program
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.
Hyperbaric Oxygen Therapy (HBOT) and Exercise Program
HBOT provided with 100% oxygen at 2.0 ATA and rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
Exercise Program
Rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
Hyperbaric Multiplace Chamber
Patients will receive treatment in a multiplace Hyperbaric Chamber
Group B Exercise Program
Group B: Exercise Program in the hyperbaric medical unit without exposure to HBOT
Exercise Program
Rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
Interventions
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Hyperbaric Oxygen Therapy (HBOT) and Exercise Program
HBOT provided with 100% oxygen at 2.0 ATA and rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
Exercise Program
Rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
Hyperbaric Multiplace Chamber
Patients will receive treatment in a multiplace Hyperbaric Chamber
Eligibility Criteria
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Inclusion Criteria
* history of ischemic or hemorrhagic stroke 6-48 months confirmed by CT
* arm hemiparesis/hemiplegia
* Chedoke-McMaster Stroke Assessment Scale 3-6
* ability to follow verbal commands
Exclusion Criteria
* severe cognitive dysfunction (The Mini Mental State Examination \<24 )
* claustrophobia
* seizure disorder
* active asthma
* severe chronic obstructive pulmonary disease
* history of spontaneous pneumothorax
* history of severe congestive heart failure with left ventricular ejection fraction \< 30%; unstable angina
* myocardial infarction (within the last 3 months)
* chronic sinusitis
* chronic acute otitis media or major ear drum trauma
* current treatment with bleomycin, cisplatin, doxorubicin and disulfiram
* participation in another investigative drug or device trial currently or within the last 30 days
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Jo Carroll
Manager Anesthesia Research
Principal Investigators
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Rita Katznelson, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Denyse Richardson, MD
Role: PRINCIPAL_INVESTIGATOR
Toronto Rehabilitation Institute, UHN
Locations
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Toronto General Hospital, University Health Network
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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15-8834-D
Identifier Type: -
Identifier Source: org_study_id