An Early Phase 1 interventional study of HBOT and OMT in Stroke, Motor Dysfunction and Chronic Stroke, sponsored by Abington Memorial Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-12-21.
Sponsored by Abington Memorial Hospital · Early Phase 1, Interventional, and Treatment
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
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's enrollment of 5 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Abington Memorial Hospital is the lead sponsor of 9 studies on the registry; none are open to participants now.
Compared within Ischemic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subacute stroke patients post stroke within 3 months of enrollment, have persistent neurological deficits despite conventional rehabilitation
Combination Product: HBOT and OMT
Chronic stroke patients more than 6 months from stroke with persistent neurological deficits despite conventional rehabilitation
Combination Product: HBOT and OMT
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.
Also known as: Osteopathic manipulative therapies (OMT), Hyperbaric Oxygen Therapy (HBOT)
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
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Jul 2021, 41 months.
Of 42 phase 1 interventional studies under Ischemic Stroke, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's 41 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Abington Memorial Hospital