search
Back to results

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

Primary Purpose

Stroke, Motor Dysfunction, Chronic Stroke

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
HBOT and OMT
Sponsored by
Abington Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Abington Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Subacute Ischemic Stroke

Chronic Ischemic Stroke

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Beck Depression Inventory
assessment of Depression scale rating
Wolf Motor Score
assessment of functional motor recovery
Rivermead Extended Activities of Daily Living (EADL) scale
assessment of capability navigating usual and community based ADLs
Medical Outcomes 36 Item
assessment of global health
Functional Independence Measure (FIM)
universally used assessment of patient's ability to perform activities of daily living

Full Information

First Posted
November 14, 2017
Last Updated
December 20, 2021
Sponsor
Abington Memorial Hospital
Collaborators
Philadelphia College of Osteopathic Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT03352232
Brief Title
Hyperbaric Oxygen and Manipulative Therapies to Regain Function Post Stroke
Acronym
HBOT/OMT
Official Title
Oxygenating the Potential: Hyperbaric Oxygen and Manipulative Therapies to Regain Function in Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 3, 2018 (Actual)
Primary Completion Date
July 19, 2021 (Actual)
Study Completion Date
July 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abington Memorial Hospital
Collaborators
Philadelphia College of Osteopathic Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Motor Dysfunction, Chronic Stroke, Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subacute Ischemic Stroke
Arm Type
Experimental
Arm Description
Subacute stroke patients post stroke within 3 months of enrollment, have persistent neurological deficits despite conventional rehabilitation
Arm Title
Chronic Ischemic Stroke
Arm Type
Experimental
Arm Description
Chronic stroke patients more than 6 months from stroke with persistent neurological deficits despite conventional rehabilitation
Intervention Type
Combination Product
Intervention Name(s)
HBOT and OMT
Other Intervention Name(s)
Osteopathic manipulative therapies (OMT), Hyperbaric Oxygen Therapy (HBOT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
National Institute of Health Stroke Score (NIHSS) 0-5 or Modified Rankin Score (mRS) 0-2
Description
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
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Description
assessment of Depression scale rating
Time Frame
90 days
Title
Wolf Motor Score
Description
assessment of functional motor recovery
Time Frame
90 days
Title
Rivermead Extended Activities of Daily Living (EADL) scale
Description
assessment of capability navigating usual and community based ADLs
Time Frame
90 days
Title
Medical Outcomes 36 Item
Description
assessment of global health
Time Frame
90 days
Title
Functional Independence Measure (FIM)
Description
universally used assessment of patient's ability to perform activities of daily living
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hana Choe, MD
Organizational Affiliation
Abington Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hyperbaric Oxygen and Manipulative Therapies to Regain Function Post Stroke

We'll reach out to this number within 24 hrs