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HBOT Global Functioning After Stroke

NCT02666469 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-12-13

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Rita Katznelson, MD · University Health Network, Toronto

  • Denyse Richardson, MD · Toronto Rehabilitation Institute, UHN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-02-28
Completion
2018-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02666469 on ClinicalTrials.gov