Clinical trial NCT03352232: Hyperbaric Oxygen and Manipulative Therapies to Regain Function Post Stroke
Official title: Oxygenating the Potential: Hyperbaric Oxygen and Manipulative Therapies to Regain Function in Stroke Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stroke
Motor Dysfunction
Chronic Stroke
Ischemic Stroke
Lead sponsor: Abington Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Philadelphia College of Osteopathic Medicine
First posted: 2017-11-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: National Institute of Health Stroke Score (NIHSS) 0-5 or Modified Rankin Score (mRS) 0-2
timeFrame: 90 Days
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: 90 days
measure: Wolf Motor Score
timeFrame: 90 days
measure: Rivermead Extended Activities of Daily Living (EADL) scale
timeFrame: 90 days
measure: Medical Outcomes 36 Item
timeFrame: 90 days
measure: Functional Independence Measure (FIM)
timeFrame: 90 days
Other outcomes:
Locations:
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
Study officials:
affiliation: Abington Memorial Hospital
name: Hana Choe, MD
role: PRINCIPAL_INVESTIGATOR
References: