StrokeEarly Phase 1HBOT/OMTNCT03352232
Hyperbaric Oxygen and Manipulative Therapies to Regain Function Post Stroke
A Early Phase 1 study testing HBOT and OMT in people with Stroke and Motor Dysfunction, run by Abington Memorial Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Motor Dysfunction, Chronic Stroke
- What is being tested?
- HBOT and OMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2018to 19 Jul 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- Prior history of depression requiring medications
- Pregnancy
- Concomitant non-conventional rehab therapies including: acupuncture, botulinum toxin injections, massage therapy
- Significant claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Abington Memorial Hospital
Abington, Pennsylvania, 19001
About this study
Official title: Oxygenating the Potential: Hyperbaric Oxygen and Manipulative Therapies to Regain Function in Stroke Survivors
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.
Read the 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
- Conditions
- Stroke, Motor Dysfunction, Chronic Stroke, Ischemic Stroke
- Being tested
- HBOT and OMT
- Medical subject headings
- Stroke, Neurologic Manifestations, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBOT and OMTCombination product
Also called Osteopathic manipulative therapies (OMT), Hyperbaric Oxygen Therapy (HBOT)
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.
| Study group | Role | What they receive |
|---|---|---|
| Subacute Ischemic Stroke | Experimental | Subacute stroke patients post stroke within 3 months of enrollment, have persistent neurological deficits despite conventional rehabilitation Receives: Combination Product: HBOT and OMT |
| Chronic Ischemic Stroke | Experimental | Chronic stroke patients more than 6 months from stroke with persistent neurological deficits despite conventional rehabilitation Receives: Combination Product: HBOT and OMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 Days
Secondary outcomes (5)
Beck Depression Inventory
assessment of Depression scale rating
Measured: 90 days
Wolf Motor Score
assessment of functional motor recovery
Measured: 90 days
Rivermead Extended Activities of Daily Living (EADL) scale
assessment of capability navigating usual and community based ADLs
Measured: 90 days
Medical Outcomes 36 Item
assessment of global health
Measured: 90 days
Functional Independence Measure (FIM)
universally used assessment of patient's ability to perform activities of daily living
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start3 Feb 2018
- Primary completion19 Jul 2021
- Study completion19 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abington Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Philadelphia College of Osteopathic Medicine
- Responsible party
- Principal investigator, Hana Choe, Abington Memorial Hospital
- Investigators
- Hana Choe, MD, Principal investigator, Abington Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352232
- Sponsor's protocol ID
- 14-063
- Acronym
- HBOT/OMT
- Status last verified
- Dec 2021
- First submitted
- 14 Nov 2017
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygenating the Potential: Hyperbaric Oxygen and Manipulative Therapies to Regain Function in Stroke Survivors
- ClinicalTrials.gov ID
- NCT03352232
- Acronym / sponsor ID
- HBOT/OMT / 14-063
- Conditions
- Stroke, Motor Dysfunction, Chronic Stroke, Ischemic Stroke
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Abington Memorial HospitalUniversity, hospital or other
- Collaborators
- Philadelphia College of Osteopathic Medicine
- Study start
- 3 Feb 2018 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 19 Jul 2021 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Subacute Ischemic Stroke | Experimental | Combination Product: HBOT and OMTSubacute stroke patients post stroke within 3 months of enrollment, have persistent neurological deficits despite conventional rehabilitation |
| Chronic Ischemic Stroke | Experimental | Combination Product: HBOT and OMTChronic stroke patients more than 6 months from stroke with persistent neurological deficits despite conventional rehabilitation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBOT and OMTAlso: Osteopathic manipulative therapies (OMT), Hyperbaric Oxygen Therapy (HBOT)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. | Combination product | Chronic Ischemic Stroke, Subacute Ischemic Stroke |
Primary outcome
National Institute of Health Stroke Score (NIHSS) 0-5 or Modified Rankin Score (mRS) 0-2
Time frame: 90 Days
Primary Outcome NIHSS 0-5, 0 without deficits; mRS 0-2, 0 without disability - 2 slight disability, no need for assistance
5 secondary outcomes
Beck Depression Inventory
Time frame: 90 days
Wolf Motor Score
Time frame: 90 days
Rivermead Extended Activities of Daily Living (EADL) scale
Time frame: 90 days
Medical Outcomes 36 Item
Time frame: 90 days
Functional Independence Measure (FIM)
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hana Choe, MD principal investigator
Abington Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HBOT and OMT in people with Stroke and Motor Dysfunction, run by Abington Memorial Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institute of Health Stroke Score (NIHSS) 0-5 or Modified Rankin Score (mRS) 0-2 (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.