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

Oxygenating the Potential: Hyperbaric Oxygen and Manipulative Therapies to Regain Function in Stroke Survivors

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Ischemic Stroke; Chronic Stroke; Motor Dysfunction
• Intervention / Treatment: Combination product: HBOT and OMT

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abington Memorial Hospital
• Collaborators: Philadelphia College of Osteopathic Medicine
• Investigators: Principal Investigator: Hana Choe, MD, Abington Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2018
• Primary Completion (Actual): July 19, 2021
• Study Completion (Actual): July 19, 2021

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 14-063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No