HBOT Global Functioning After Stroke

December 12, 2019 updated by: Jo Carroll, University Health Network, Toronto

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

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 Overview

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital, University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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
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.
HBOT provided with 100% oxygen at 2.0 ATA and rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
Rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
Patients will receive treatment in a multiplace Hyperbaric Chamber
Active Comparator: Group B Exercise Program
Group B: Exercise Program in the hyperbaric medical unit without exposure to HBOT
Rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Denyse Richardson, MD, Toronto Rehabilitation Institute, UHN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

January 24, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 12, 2019

Last Verified

December 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Hyperbaric Oxygen Therapy (HBOT) and Exercise Program

3
Subscribe