Trial | NCT03352232  Report issue

Title

Hyperbaric Oxygen and Manipulative Therapies to Regain Function Post Stroke
Oxygenating the Potential: Hyperbaric Oxygen and Manipulative Therapies to Regain Function in Stroke Survivors

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    5
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
Study Started
Feb 03
2018
Primary Completion
Jul 19
2021
Study Completion
Jul 19
2021
Last Update
Dec 21
2021

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.

  • Other names: Osteopathic manipulative therapies (OMT), Hyperbaric Oxygen Therapy (HBOT)

Subacute Ischemic Stroke Experimental

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

Chronic Ischemic Stroke Experimental

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

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted