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Completed

NCT Number: NCT02666469

HBOT 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperbaric Oxygen Therapy (HBOT) and Exercise Program

Other

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

exercise program

Other

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

Hyperbaric Multiplace Chamber

Device

Patients will receive treatment in a multiplace Hyperbaric Chamber

Primary outcomes

  1. Number or participants finishing the trial

    Time frame: 8 weeks

    The number of patients finishing the trial

Secondary outcomes

  1. Total time spent doing rehabilitation exercise

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 28, 2016
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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