Hyperbaric Oxygen and Manipulative Therapies to Regain Function Post Stroke

Early Phase 1

Completed

• Conditions: Ischemic Stroke; Stroke; Motor Dysfunction; Chronic Stroke
• Interventions: Combination Product: HBOT and OMT

• Registration Number: NCT03352232
• Lead Sponsor: Abington Memorial Hospital

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-24
• Study Start: 2018-02-03
• Primary Completion: 2021-07-19
• Study Completion: 2021-07-19
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-20
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subacute Ischemic Stroke	HBOT and OMT	Subacute stroke patients post stroke within 3 months of enrollment, have persistent neurological deficits despite conventional rehabilitation
Chronic Ischemic Stroke	HBOT and OMT	Chronic stroke patients more than 6 months from stroke with persistent neurological deficits despite conventional rehabilitation

Primary Outcome Measures

Name	Time	Method
National Institute of Health Stroke Score (NIHSS) 0-5 or Modified Rankin Score (mRS) 0-2	90 Days	Primary Outcome NIHSS 0-5, 0 without deficits; mRS 0-2, 0 without disability - 2 slight disability, no need for assistance

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Abington Memorial Hospital; 🇺🇸 Abington, Pennsylvania, United States