Clinical trial NCT02666469: HBOT Global Functioning After Stroke
Official title: Hyperbaric Oxygen and Focused Rehabilitation Program: A Feasibility Study in Improving Global Functioning After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Hyperbaric oxygen treatment, rehabilitation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number or participants finishing the trial
timeFrame: 8 weeks
Secondary outcomes:
measure: Total time spent doing rehabilitation exercise
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Rita Katznelson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto Rehabilitation Institute, UHN
name: Denyse Richardson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schiavo S, Richardson D, Santa Mina D, Buryk-Iggers S, Uehling J, Carroll J, Clarke H, Djaiani C, Gershinsky M, Katznelson R. Hyperbaric oxygen and focused rehabilitation program: a feasibility study in improving upper limb motor function after stroke. Appl Physiol Nutr Metab. 2020 Dec;45(12):1345-1352. doi: 10.1139/apnm-2020-0124. Epub 2020 Jun 23.