HBOT Global Functioning After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hyperbaric Oxygen Therapy (HBOT) and Exercise Program
Exercise Program
Hyperbaric Multiplace Chamber
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Hyperbaric oxygen treatment, rehabilitation
Eligibility Criteria
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
Sites / Locations
- Toronto General Hospital, University Health Network
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A Hyperbaric Oxygen Therapy and Exercise Program
Group B Exercise Program
Arm 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.
Group B: Exercise Program in the hyperbaric medical unit without exposure to HBOT
Outcomes
Primary Outcome Measures
Number or participants finishing the trial
The number of patients finishing the trial
Secondary Outcome Measures
Total time spent doing rehabilitation exercise
Total time spent engaging in rehabilitation exercise (GRASP) in the trial
Full Information
NCT ID
NCT02666469
First Posted
November 30, 2015
Last Updated
December 12, 2019
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02666469
Brief Title
HBOT Global Functioning After Stroke
Official Title
Hyperbaric Oxygen and Focused Rehabilitation Program: A Feasibility Study in Improving Global Functioning After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Hyperbaric oxygen treatment, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A Hyperbaric Oxygen Therapy and Exercise Program
Arm Type
Active Comparator
Arm 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.
Arm Title
Group B Exercise Program
Arm Type
Active Comparator
Arm Description
Group B: Exercise Program in the hyperbaric medical unit without exposure to HBOT
Intervention Type
Other
Intervention Name(s)
Hyperbaric Oxygen Therapy (HBOT) and Exercise Program
Intervention Description
HBOT provided with 100% oxygen at 2.0 ATA and rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
Intervention Type
Other
Intervention Name(s)
Exercise Program
Intervention Description
Rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
Intervention Type
Device
Intervention Name(s)
Hyperbaric Multiplace Chamber
Intervention Description
Patients will receive treatment in a multiplace Hyperbaric Chamber
Primary Outcome Measure Information:
Title
Number or participants finishing the trial
Description
The number of patients finishing the trial
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Total time spent doing rehabilitation exercise
Description
Total time spent engaging in rehabilitation exercise (GRASP) in the trial
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Katznelson, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Denyse Richardson, MD
Organizational Affiliation
Toronto Rehabilitation Institute, UHN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
32574506
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.
Results Reference
derived
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HBOT Global Functioning After Stroke
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