HBOT Global Functioning After Stroke

Recruiting

Phase N/A Results N/A

Trial Description

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

  • Exercise Program Behavioral
    Intervention Desc: Rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
    ARM 1: Kind: Experimental
    Label: Group A Hyperbaric Oxygen Therapy and Exercise Program
    Description: 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.
    ARM 2: Kind: Experimental
    Label: Group B Exercise Program
    Description: Group B: Exercise Program in the hyperbaric medical unit without exposure to HBOT
  • Hyperbaric Oxygen Therapy (HBOT) and Exercise Program Other
    Intervention Desc: HBOT provided with 100% oxygen at 2.0 ATA and rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
    ARM 1: Kind: Experimental
    Label: Group A Hyperbaric Oxygen Therapy and Exercise Program
    Description: 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.
  • Hyperbaric Multiplace Chamber Device
    Intervention Desc: Patients will receive treatment in a multiplace Hyperbaric Chamber
    ARM 1: Kind: Experimental
    Label: Group A Hyperbaric Oxygen Therapy and Exercise Program
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Number or participants finishing the trial 8 weeks No
Secondary Total time spent doing rehabilitation exercise 8 weeks No

Sponsors