MedDataX Logo

Hyperbaric Oxygen and Manipulative Therapies to Regain Function Post Stroke

NCT ID: NCT03352232

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-03

Study Completion Date

2021-07-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Motor Dysfunction Chronic Stroke Ischemic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Subacute Ischemic Stroke

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

Group Type EXPERIMENTAL

HBOT and OMT

Intervention Type COMBINATION_PRODUCT

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.

Chronic Ischemic Stroke

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

Group Type EXPERIMENTAL

HBOT and OMT

Intervention Type COMBINATION_PRODUCT

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Osteopathic manipulative therapies (OMT) Hyperbaric Oxygen Therapy (HBOT)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Philadelphia College of Osteopathic Medicine

OTHER

Sponsor Role collaborator

Abington Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hana Choe

Assistant Director NeuroIntervention and Neurocritical Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hana Choe, MD

Role: PRINCIPAL_INVESTIGATOR

Abington Memorial Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Abington Memorial Hospital

Abington, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14-063

Identifier Type: -

Identifier Source: org_study_id