HBOT Global Functioning After Stroke

University Health Network, Toronto21 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number or participants finishing the trial

The number of patients finishing the trial

Time frame: 8 weeks

Secondary Outcomes

Total time spent doing rehabilitation exercise

Total time spent engaging in rehabilitation exercise (GRASP) in the trial