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Completed

NCT Number: NCT03352232

Hyperbaric Oxygen and Manipulative Therapies to Regain Function Post Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Stroke Ischemic Stroke Motor Dysfunction Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HBOT and OMT

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.

Other names: Osteopathic manipulative therapies (OMT), Hyperbaric Oxygen Therapy (HBOT)

Primary outcomes

  1. 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

Secondary outcomes

  1. Beck Depression Inventory

    Time frame: 90 days

    assessment of Depression scale rating

  2. Wolf Motor Score

    Time frame: 90 days

    assessment of functional motor recovery

  3. Rivermead Extended Activities of Daily Living (EADL) scale

    Time frame: 90 days

    assessment of capability navigating usual and community based ADLs

  4. Medical Outcomes 36 Item

    Time frame: 90 days

    assessment of global health

  5. Functional Independence Measure (FIM)

    Time frame: 90 days

    universally used assessment of patient's ability to perform activities of daily living

Sponsors and collaborators

Lead sponsor

Abington Memorial Hospital

Other

Collaborators

  • Philadelphia College of Osteopathic Medicine

Registry information

Official study title

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

Acronym: HBOT/OMT

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 24, 2017
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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