HBOT Global Functioning After Stroke

Study Overview
=================
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.

Official Title
-----------------
Hyperbaric Oxygen and Focused Rehabilitation Program: A Feasibility Study in Improving Global Functioning After Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Hyperbaric Oxygen Therapy (HBOT) and Exercise Program
* Other: Exercise Program
* Device: Hyperbaric Multiplace Chamber


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A Hyperbaric Oxygen Therapy and Exercise Program<br>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. | Other: Hyperbaric Oxygen Therapy (HBOT) and Exercise Program<br>* HBOT provided with 100% oxygen at 2.0 ATA and rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)<br>Other: Exercise Program<br>* Rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)<br>Device: Hyperbaric Multiplace Chamber<br>* Patients will receive treatment in a multiplace Hyperbaric Chamber<br>|
| Active Comparator: Group B Exercise Program<br>Group B: Exercise Program in the hyperbaric medical unit without exposure to HBOT | Other: Exercise Program<br>* Rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number or participants finishing the trial | The number of patients finishing the trial | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time spent doing rehabilitation exercise | Total time spent engaging in rehabilitation exercise (GRASP) in the trial | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperbaric oxygen treatment, rehabilitation