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| Name | Class |
|---|---|
| Philadelphia College of Osteopathic Medicine | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subacute Ischemic Stroke | Experimental | Subacute stroke patients post stroke within 3 months of enrollment, have persistent neurological deficits despite conventional rehabilitation |
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| Chronic Ischemic Stroke | Experimental | Chronic stroke patients more than 6 months from stroke with persistent neurological deficits despite conventional rehabilitation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBOT and OMT | Combination 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory | assessment of Depression scale rating | 90 days |
| Wolf Motor Score | assessment of functional motor recovery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hana Choe, MD | Abington Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009461 | Neurologic Manifestations |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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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.
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| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |