Hyperbaric Oxygen and Manipulative Therapies to Regain Function Post Stroke

Early Phase 1CompletedNCT03352232

Abington Memorial Hospital5 enrolled

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke Motor Dysfunction Chronic Stroke Ischemic Stroke

Interventions

HBOT and OMTCOMBINATION_PRODUCT

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Abington Memorial Hospital

Abington, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: 90 Days

Secondary Outcomes

Beck Depression Inventory

assessment of Depression scale rating

Time frame: 90 days

Wolf Motor Score

assessment of functional motor recovery

Time frame: 90 days

Rivermead Extended Activities of Daily Living (EADL) scale

assessment of capability navigating usual and community based ADLs

Time frame: 90 days

Medical Outcomes 36 Item

assessment of global health

Time frame: 90 days

Functional Independence Measure (FIM)

universally used assessment of patient's ability to perform activities of daily living

Time frame: 90 days

Data from ClinicalTrials.gov

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