Hyperbaric Oxygen and Manipulative Therapies to Regain Function Post Stroke

Stroke Clinical Trial

— HBOT/OMT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03352232
• Other study ID #: 14-063
• Status: Completed
• Phase: Early Phase 1
• Start date: February 3, 2018
• Est. completion date: July 19, 2021

Study information

• Verified date: December 2021
• Source: Abington Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 19, 2021
• Est. primary completion date: July 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Stroke
• Ischemic Stroke
• Motor Dysfunction
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abington Memorial Hospital	Philadelphia College of Osteopathic Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	90 Days
Secondary	Beck Depression Inventory	assessment of Depression scale rating	90 days
Secondary	Wolf Motor Score	assessment of functional motor recovery	90 days
Secondary	Rivermead Extended Activities of Daily Living (EADL) scale	assessment of capability navigating usual and community based ADLs	90 days
Secondary	Medical Outcomes 36 Item	assessment of global health	90 days
Secondary	Functional Independence Measure (FIM)	universally used assessment of patient's ability to perform activities of daily living	90 days