Hyperbaric Oxygen and Manipulative Therapies to Regain Function Post Stroke

Overview

To study safety, feasibility and outcomes of combining osteopathic manipulative therapies with hyperbaric oxygen therapy in reducing the functional deficits in stroke survivors in subacute and chronic phases post ischemic stroke. To document the same as part of a pilot project in anticipation of further investigational studies.

Full Title of Study: “Oxygenating the Potential: Hyperbaric Oxygen and Manipulative Therapies to Regain Function in Stroke Survivors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 19, 2021

Detailed Description

The primary objective of this study is to show that hyperbaric oxygen therapy combined with osteopathic manipulative therapies improve outcomes in patients who have persistent neurological deficits after ischemic stroke compared to historical norms. The secondary objectives of this study is to demonstrate safety and feasibility of treating patients post stroke with hyperbaric oxygen and osteopathic therapies as well as determine improvements in multiple assessment scales of motor function, depression, activities of daily living(ADL) and pain

Interventions

  • Combination Product: HBOT and OMT
    • Hyperbaric oxygen therapy (HBOT) is defined as breathing 100% oxygen at increased atmospheric pressure. Osteopathic manipulative therapy (OMT) is used for myriad ailments including contractures, pain, spasticity. Patients in intervention arms will receive hyperbaric oxygen therapy at 2ATM (atmospheres) for 90minutes daily for up to 6weeks. In addition, they will receive osteopathic manipulative therapies twice a week during the same treatment phase.

Arms, Groups and Cohorts

  • Experimental: Subacute Ischemic Stroke
    • Subacute stroke patients post stroke within 3 months of enrollment, have persistent neurological deficits despite conventional rehabilitation
  • Experimental: Chronic Ischemic Stroke
    • Chronic stroke patients more than 6 months from stroke with persistent neurological deficits despite conventional rehabilitation

Clinical Trial Outcome Measures

Primary Measures

  • National Institute of Health Stroke Score (NIHSS) 0-5 or Modified Rankin Score (mRS) 0-2
    • Time Frame: 90 Days
    • Primary Outcome NIHSS 0-5, 0 without deficits; mRS 0-2, 0 without disability – 2 slight disability, no need for assistance

Secondary Measures

  • Beck Depression Inventory
    • Time Frame: 90 days
    • assessment of Depression scale rating
  • Wolf Motor Score
    • Time Frame: 90 days
    • assessment of functional motor recovery
  • Rivermead Extended Activities of Daily Living (EADL) scale
    • Time Frame: 90 days
    • assessment of capability navigating usual and community based ADLs
  • Medical Outcomes 36 Item
    • Time Frame: 90 days
    • assessment of global health
  • Functional Independence Measure (FIM)
    • Time Frame: 90 days
    • universally used assessment of patient’s ability to perform activities of daily living

Participating in This Clinical Trial

Inclusion Criteria

1. Post Ischemic stroke 2. Patients aged 18-80 3. NIHSS >5 4. mRS>/=3, which connotes moderate disability requiring some help. 5. Persistent significant motor dysfunction of at least one arm 6. Subacute stroke patients (within three months from time of stroke) 7. Chronic stroke patients (more than 6months from time of stroke) 8. Patient must be able to understand instructions and verbalize discomfort 9. Reliable attendance for daily (M-F) HBOT treatment and 2x/week OMT sessions for up to 6weeks Exclusion Criteria:

1. Hemorrhagic stroke 2. Prior functional disability mRS >1 3. Expressive or receptive aphasia 4. Bedbound patients due to lifting limitations for HBOT 5. History of severe, advanced emphysema with bullous disease 6. Prior history of spontaneous pneumothorax or chest surgery 7. Prior history of depression requiring medications 8. Pregnancy 9. Concomitant non-conventional rehab therapies including: acupuncture, botulinum toxin injections, massage therapy 10. Significant claustrophobia

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abington Memorial Hospital
  • Collaborator
    • Philadelphia College of Osteopathic Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hana Choe, Assistant Director NeuroIntervention and Neurocritical Care – Abington Memorial Hospital
  • Overall Official(s)
    • Hana Choe, MD, Principal Investigator, Abington Memorial Hospital

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