- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02666469
HBOT Global Functioning After Stroke
Hyperbaric Oxygen and Focused Rehabilitation Program: A Feasibility Study in Improving Global Functioning After Stroke
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.
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital, University Health Network
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age > 18 years
- 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:
- women with positive pregnancy test or plans to become pregnant during the study period
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
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HBOT provided with 100% oxygen at 2.0 ATA and rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
Rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
Patients will receive treatment in a multiplace Hyperbaric Chamber
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Active Comparator: Group B Exercise Program
Group B: Exercise Program in the hyperbaric medical unit without exposure to HBOT
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Rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number or participants finishing the trial
Time Frame: 8 weeks
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The number of patients finishing the trial
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total time spent doing rehabilitation exercise
Time Frame: 8 weeks
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Total time spent engaging in rehabilitation exercise (GRASP) in the trial
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8 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Denyse Richardson, MD, Toronto Rehabilitation Institute, UHN
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-8834-D
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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