Stroke
Conditions
Keywords
Hyperbaric oxygen treatment, rehabilitation
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.
Interventions
OTHERHyperbaric 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)
OTHERExercise Program
Rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
DEVICEHyperbaric Multiplace Chamber
Patients will receive treatment in a multiplace Hyperbaric Chamber
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number or participants finishing the trial | 8 weeks | The number of patients finishing the trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total time spent doing rehabilitation exercise | 8 weeks | Total time spent engaging in rehabilitation exercise (GRASP) in the trial |
Countries
Canada
Outcome results
None listed