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

HBOT Global Functioning After Stroke

Sponsors

Lead sponsor: University Health Network, Toronto

Source University Health Network, Toronto
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.

Overall Status Completed
Start Date October 2015
Completion Date December 2018
Primary Completion Date February 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Number or participants finishing the trial 8 weeks
Secondary Outcome
Measure Time Frame
Total time spent doing rehabilitation exercise 8 weeks
Enrollment 21
Condition
Intervention

Intervention type: Other

Intervention name: Hyperbaric Oxygen Therapy (HBOT) and Exercise Program

Description: HBOT provided with 100% oxygen at 2.0 ATA and rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)

Arm group label: Group A Hyperbaric Oxygen Therapy and Exercise Program

Intervention type: Other

Intervention name: Exercise Program

Description: Rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)

Intervention type: Device

Intervention name: Hyperbaric Multiplace Chamber

Description: Patients will receive treatment in a multiplace Hyperbaric Chamber

Arm group label: Group A Hyperbaric Oxygen Therapy and Exercise Program

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Location
facility Toronto General Hospital, University Health Network
Location Countries

Canada

Verification Date

December 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University Health Network, Toronto

Investigator full name: Jo Carroll

Investigator title: Manager Anesthesia Research

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Group A Hyperbaric Oxygen Therapy and Exercise Program

Arm group type: Active Comparator

Description: 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.

Arm group label: Group B Exercise Program

Arm group type: Active Comparator

Description: Group B: Exercise Program in the hyperbaric medical unit without exposure to HBOT

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov