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HBOT Global Functioning After Stroke

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT02666469
Collaborator
(none)
21
Enrollment
1
Location
2
Arms
38
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hyperbaric Oxygen Therapy (HBOT) and Exercise Program
  • Other: Exercise Program
  • Device: Hyperbaric Multiplace Chamber
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Hyperbaric Oxygen and Focused Rehabilitation Program: A Feasibility Study in Improving Global Functioning After Stroke
Actual Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Feb 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

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.

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)

Other: 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
Active Comparator: Group B Exercise Program

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

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

Outcome Measures

Primary Outcome Measures

  1. Number or participants finishing the trial [8 weeks]

    The number of patients finishing the trial

Secondary Outcome Measures

  1. Total time spent doing rehabilitation exercise [8 weeks]

    Total time spent engaging in rehabilitation exercise (GRASP) in the trial

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Toronto General Hospital, University Health Network Toronto Ontario Canada M5G 2C4

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Rita Katznelson, MD, University Health Network, Toronto
  • Principal Investigator: Denyse Richardson, MD, Toronto Rehabilitation Institute, UHN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jo Carroll, Manager Anesthesia Research, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02666469
Other Study ID Numbers:
  • 15-8834-D
First Posted:
Jan 28, 2016
Last Update Posted:
Dec 13, 2019
Last Verified:
Dec 1, 2019
Keywords provided by Jo Carroll, Manager Anesthesia Research, University Health Network, Toronto
Hyperbaric oxygen treatment, rehabilitation
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Dec 13, 2019