HBOT Global Functioning After Stroke

University Health Network, Toronto

Status: Completed

Conditions: Stroke

Treatments: Other: Hyperbaric Oxygen Therapy (HBOT) and Exercise Program; Other: Exercise Program; Device: Hyperbaric Multiplace Chamber

Study type: Interventional

Funder types: Other

Identifiers

NCT02666469

15-8834-D

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Group A Hyperbaric Oxygen Therapy and Exercise Program

Active Comparator group

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.

Treatment:

Other: Hyperbaric Oxygen Therapy (HBOT) and Exercise Program

Other: Exercise Program

Device: Hyperbaric Multiplace Chamber

Group B Exercise Program

Active Comparator group

Description:

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

Treatment:

Other: Exercise Program