Status:
COMPLETED
Hyperbaric Oxygen and Manipulative Therapies to Regain Function Post Stroke
Lead Sponsor:
Abington Memorial Hospital
Collaborating Sponsors:
Philadelphia College of Osteopathic Medicine
Conditions:
Stroke
Motor Dysfunction
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
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...
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 af...
Eligibility Criteria
Inclusion
- Post Ischemic stroke
- Patients aged 18-80
- NIHSS \>5
- mRS\>/=3, which connotes moderate disability requiring some help.
- Persistent significant motor dysfunction of at least one arm
- Subacute stroke patients (within three months from time of stroke)
- Chronic stroke patients (more than 6months from time of stroke)
- Patient must be able to understand instructions and verbalize discomfort
- Reliable attendance for daily (M-F) HBOT treatment and 2x/week OMT sessions for up to 6weeks
Exclusion
- Hemorrhagic stroke
- Prior functional disability mRS \>1
- Expressive or receptive aphasia
- Bedbound patients due to lifting limitations for HBOT
- History of severe, advanced emphysema with bullous disease
- Prior history of spontaneous pneumothorax or chest surgery
- Prior history of depression requiring medications
- Pregnancy
- Concomitant non-conventional rehab therapies including: acupuncture, botulinum toxin injections, massage therapy
- Significant claustrophobia
Key Trial Info
Start Date :
February 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03352232
Start Date
February 3 2018
End Date
July 19 2021
Last Update
December 21 2021
Active Locations (1)
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1
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001