StrokeNCT02666469
HBOT Global Functioning After Stroke
A study testing Hyperbaric Oxygen Therapy (HBOT) and Exercise Program, Exercise Program and Hyperbaric Multiplace Chamber in people with Stroke, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Hyperbaric Oxygen Therapy (HBOT) and Exercise Program, Exercise Program and Hyperbaric Multiplace Chamber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- Hyperbaric Oxygen Therapy (HBOT) and Exercise Program, Exercise Program, Hyperbaric Multiplace Chamber
- Keywords
- Hyperbaric oxygen treatment, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen Therapy (HBOT) and Exercise ProgramOther
HBOT provided with 100% oxygen at 2.0 ATA and rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
Exercise ProgramOther
Rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
Hyperbaric Multiplace ChamberDevice
Patients will receive treatment in a multiplace Hyperbaric Chamber
| Study group | Role | What they receive |
|---|---|---|
| Group A Hyperbaric Oxygen Therapy and Exercise Program | Active comparator | 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. Receives: Other: Hyperbaric Oxygen Therapy (HBOT) and Exercise Program; Other: Exercise Program; Device: Hyperbaric Multiplace Chamber |
| Group B Exercise Program | Active comparator | Group B: Exercise Program in the hyperbaric medical unit without exposure to HBOT Receives: Other: Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number or participants finishing the trial
The number of patients finishing the trial
Measured: 8 weeks
Secondary outcomes (1)
Total time spent doing rehabilitation exercise
Total time spent engaging in rehabilitation exercise (GRASP) in the trial
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionFeb 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jo Carroll, University Health Network, Toronto
- Investigators
- Rita Katznelson, MD, Principal investigator, University Health Network, TorontoDenyse Richardson, MD, Principal investigator, Toronto Rehabilitation Institute, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666469
- Sponsor's protocol ID
- 15-8834-D
- Status last verified
- Dec 2019
- First submitted
- 30 Nov 2015
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32574506
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen and Focused Rehabilitation Program: A Feasibility Study in Improving Global Functioning After Stroke
- ClinicalTrials.gov ID
- NCT02666469
- Acronym / sponsor ID
- 15-8834-D
- Conditions
- Stroke
- Keywords
- Hyperbaric oxygen treatment, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Hyperbaric Oxygen Therapy and Exercise Program | Active comparator | Other: Hyperbaric Oxygen Therapy (HBOT) and Exercise Program, Other: Exercise Program, Device: Hyperbaric Multiplace ChamberGroup 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 comparator | Other: Exercise ProgramGroup B: Exercise Program in the hyperbaric medical unit without exposure to HBOT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen Therapy (HBOT) and Exercise ProgramHBOT provided with 100% oxygen at 2.0 ATA and rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min) | Other | Group A Hyperbaric Oxygen Therapy and Exercise Program |
| Exercise ProgramRehabilitation program consisting of GRASP (60 min) and mental imagery (30 min) | Other | Group A Hyperbaric Oxygen Therapy and Exercise Program, Group B Exercise Program |
| Hyperbaric Multiplace ChamberPatients will receive treatment in a multiplace Hyperbaric Chamber | Device | Group A Hyperbaric Oxygen Therapy and Exercise Program |
Primary outcome
Number or participants finishing the trial
Time frame: 8 weeks
The number of patients finishing the trial
1 secondary outcome
Total time spent doing rehabilitation exercise
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Derived from this study: PubMed 32574506Schiavo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Katznelson, MD principal investigator
University Health Network, Toronto
Denyse Richardson, MD principal investigator
Toronto Rehabilitation Institute, UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Therapy (HBOT) and Exercise Program, Exercise Program and Hyperbaric Multiplace Chamber in people with Stroke, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number or participants finishing the trial (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02666469, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.