HBOT Global Functioning After Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02666469
• Other study ID #: 15-8834-D
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2018

Study information

• Verified date: December 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Hyperbaric 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)
• Exercise Program
Rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)

Device:
• Hyperbaric Multiplace Chamber
Patients will receive treatment in a multiplace Hyperbaric Chamber

Locations

Country	Name	City	State
Canada	Toronto General Hospital, University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number or participants finishing the trial	The number of patients finishing the trial	8 weeks
Secondary	Total time spent doing rehabilitation exercise	Total time spent engaging in rehabilitation exercise (GRASP) in the trial	8 weeks