HBOT Global Functioning After Stroke
Hyperbaric Oxygen and Focused Rehabilitation Program: A Feasibility Study in Improving Global Functioning After Stroke
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Oct 2015
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 30, 2015
CompletedFirst Posted
Study publicly available on registry
January 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedDecember 13, 2019
December 1, 2019
2.3 years
November 30, 2015
December 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number or participants finishing the trial
The number of patients finishing the trial
8 weeks
Secondary Outcomes (1)
Total time spent doing rehabilitation exercise
8 weeks
Study Arms (2)
Group A Hyperbaric Oxygen Therapy and Exercise Program
ACTIVE COMPARATORGroup 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
ACTIVE COMPARATORGroup B: Exercise Program in the hyperbaric medical unit without exposure to HBOT
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4, Canada
Related Publications (1)
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.
PMID: 32574506DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rita Katznelson, MD
University Health Network, Toronto
- PRINCIPAL INVESTIGATOR
Denyse Richardson, MD
Toronto Rehabilitation Institute, UHN
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Manager Anesthesia Research
Study Record Dates
First Submitted
November 30, 2015
First Posted
January 28, 2016
Study Start
October 1, 2015
Primary Completion
February 1, 2018
Study Completion
December 1, 2018
Last Updated
December 13, 2019
Record last verified: 2019-12