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Hyperbaric Oxygen and Manipulative Therapies to Regain Function Post Stroke (HBOT/OMT)

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ClinicalTrials.gov Identifier: NCT03352232
Recruitment Status : Completed
First Posted : November 24, 2017
Last Update Posted : December 21, 2021
Sponsor:
Collaborator:
Philadelphia College of Osteopathic Medicine
Information provided by (Responsible Party):
Hana Choe, Abington Memorial Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Motor Dysfunction Chronic Stroke Ischemic Stroke Combination Product: HBOT and OMT Early Phase 1

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There will be two populations based on when they experienced a stroke. Subacute stroke patients will have suffered an ischemic stroke within 3 months of enrollment and have persistent neurological deficits. The second group will be patients who suffered an ischemic stroke more than 6 months (chronic) from time of enrollment and have persistent neurological deficits compromising activities of daily living.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oxygenating the Potential: Hyperbaric Oxygen and Manipulative Therapies to Regain Function in Stroke Survivors
Actual Study Start Date : February 3, 2018
Actual Primary Completion Date : July 19, 2021
Actual Study Completion Date : July 19, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Subacute Ischemic Stroke
Subacute stroke patients post stroke within 3 months of enrollment, have persistent neurological deficits despite conventional rehabilitation
 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.
Other Names:
  • Osteopathic manipulative therapies (OMT)
  • Hyperbaric Oxygen Therapy (HBOT)
Experimental: Chronic Ischemic Stroke
Chronic stroke patients more than 6 months from stroke with persistent neurological deficits despite conventional rehabilitation
 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.
Other Names:
  • Osteopathic manipulative therapies (OMT)
  • Hyperbaric Oxygen Therapy (HBOT)


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Beck Depression Inventory [ Time Frame: 90 days ]
    assessment of Depression scale rating

  2. Wolf Motor Score [ Time Frame: 90 days ]
    assessment of functional motor recovery

  3. Rivermead Extended Activities of Daily Living (EADL) scale [ Time Frame: 90 days ]
    assessment of capability navigating usual and community based ADLs

  4. Medical Outcomes 36 Item [ Time Frame: 90 days ]
    assessment of global health

  5. Functional Independence Measure (FIM) [ Time Frame: 90 days ]
    universally used assessment of patient's ability to perform activities of daily living


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352232


Locations
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United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Sponsors and Collaborators
Abington Memorial Hospital
Philadelphia College of Osteopathic Medicine
Investigators
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Principal Investigator: Hana Choe, MD Abington Memorial Hospital
More Information
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Responsible Party: Hana Choe, Assistant Director NeuroIntervention and Neurocritical Care, Abington Memorial Hospital
ClinicalTrials.gov Identifier: NCT03352232    
Other Study ID Numbers: 14-063
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: December 21, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases