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

Abington Memorial Hospital

Status and phase: Completed; Early Phase 1

Conditions: Ischemic Stroke; Stroke; Motor Dysfunction; Chronic Stroke

Treatments: Combination Product: HBOT and OMT

Study type: Interventional

Funder types: Other

Identifiers

NCT03352232

14-063

Details and patient eligibility

About

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.

Full 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

Enrollment: 5 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Subacute Ischemic Stroke

Experimental group

Description:

Subacute stroke patients post stroke within 3 months of enrollment, have persistent neurological deficits despite conventional rehabilitation

Treatment:

Combination Product: HBOT and OMT

Chronic Ischemic Stroke

Experimental group

Description:

Chronic stroke patients more than 6 months from stroke with persistent neurological deficits despite conventional rehabilitation

Treatment:

Combination Product: HBOT and OMT