Hyperbaric Oxygen Therapy After Stroke - PILOT

April 23, 2020 updated by: Norwegian Underwater Intervention (NUI)

Hyperbaric Oxygen Therapy After Cerebral Infarction - PILOT

The goal of this pilot study is to establish more information about hyperbaric oxygen therapy for this group of patients, and give us more information of how to initiate the best possible main study. Can we find any indications that support the use of this therapy for patients suffering from chronic disability after cerebral infarction? Can we improve physical and cognitive function.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This is a pilot project including 6 patients for one session of 20 treatments of hyperbaric oxygen therapy. The objective is to establish knowledge of HBO for this group of patients in a Norwegian context, so that we can prepare for the main study afterwards, including about 60-70 patients. We need to know how to optimize the administrative and technical systems for the larger study. We want to collect feedback from the patients undergoing the pilot study. We want more information about the treatment table, if 20 treatments are enough, if 2,4 bar pressure is adequate. The treatment table is based on existing research, and is considered safe.

The patients are to be treated at table 14/90, at 2,4 Absolute atmospheres, and daly 90 minutes of oxygen inhalation (medical oxygen).

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Hordaland
      • Bergen, Hordaland, Norway, 5165
        • NUI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inlcution criteria:

  • No age restriction
  • Suffered from ischemic stroke (cerebral infarction) 6-12 months before inclusion.
  • Stable phase after standard rehabilitation
  • Measurable physical function failure and / or reduced ADL function.
  • Sufficient physical function / mobility to be able to move into / out of the pressure chamber with the help of only one person (Tender).

Patients to participate in the study must be physically, mentally and cognitively fit for pressure chamber treatment. They must be able to stand for their own help, move with support, and be able to follow instructions. This is ensured by discretionary assessment after observation and interview with the patient.

Exclusion criteria:

  • Claustrophobia
  • Psychosis, severe anxiety
  • Inability to equalize pressure in the middle ear
  • Severe COPD and asthma, pathological lung sounds
  • Hypertension (Blood pressure > 140/90 mmHg)
  • Pregnancy
  • Hernia
  • Earlier fractures, or suspected fractures in the face
  • Ongoing chemotherapy
  • Previous treatment with Bleomycin
  • Aphasia that prevents necessary communication
  • Cognitive failure that prevents necessary co-operation in the pressure chamber.
  • Previous or current pneumothorax, other lung injury

  • Increased risk of pneumothorax

    • Known or suspected injury to the chest
    • Marfan syndrome
    • Homocystinuria
    • Family history of pneumothorax
    • Chronic lung disease (COPD, Emphysema, Asthma eller cystic fibrosis)
    • Tuberculosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
One group of 6 patients undergoing 20 sessions of hyperbaric therapy at table 14/90.
Drug: Hyperbaric oxygen
20 sessions of hyperbaric therapy in a pressure chamber at 2,4 absolute atmospheres, 90 minutes per day of breathing 100% medical oxygen through an own mask. Table 14/90.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved physical and cognitive function in activities of daily living.
Time Frame: 0+6+12 months after end of treatment period
The project's physiotherapist and ergo therapist from Western Norway University of Applied Sciences (HVL) are responsible for examining physical function and the participant's ability to acquire and use knowledge, as well as function in everyday living activities (ADL). Three measurements are made before starting treatment (establishing a baseline), where the third measurement is done on the same day as treatment starts to eliminate changes in test results as a result of learning the tests. Measurements are also made immediately after the end of treatment, as well as follow-up measurements after 6 and 12 months. Descriptions below.
0+6+12 months after end of treatment period
Short Physical Performance Battery (SPPB)
Time Frame: 0+6+12 months after end of treatment period
This test is very widely used to provide a quick and validated test of strength, balance and coordination. The test has a roof effect, so it is not suitable for capturing very small and subtle self-perceived disturbances in function. The test is very sensitive to change in the target group.
0+6+12 months after end of treatment period
Grip strength
Time Frame: 0+6+12 months after end of treatment period
There is a recognized and validated connection between general function and health and grip strength, as well as between grip strength and life span. Grip strength changes as other function changes.
0+6+12 months after end of treatment period
Fatigue Severity Scale (FSC)
Time Frame: 0+6+12 months after end of treatment period
A major problem after stroke and in many brain disorders is fatigue. Fatigue leads to reduced foxing and thus loss of function. The test is believed to be able to detect changes that are relevant to everyday life function and social participation.
0+6+12 months after end of treatment period
Canadian Occupational Performance Measure (COPM)
Time Frame: 0+6+12 months after end of treatment period
COPM is designed to help people identify and prioritize activity problems, as well as evaluate activity performance and satisfaction with activity execution. In an interview, the person is asked to describe activities they consider important but find it difficult to perform. Among the aforementioned challenges, the person is asked to prioritize a maximum of five activities he / she wants to be able to perform better after the end of treatment. Then, the person is asked to score the current performance and satisfaction with the current performance of priority activities. The score scale is from 1-10 where 10 indicates very good workmanship or high satisfaction. After the interview, partial scores for execution (COPM-U) and satisfaction (COPM-T) are calculated. A change score of 3 points is considered a clinically important change. COPM has shown good measurement properties, among other things for participants with stroke and the elderly.
0+6+12 months after end of treatment period
Action Research Arm Test (ARAT)
Time Frame: 0+6+12 months after end of treatment period
ARAT is a tool designed to assess motor function in the arm after stroke. The tasks in the test reflect daily activities and the patient's ability to perform them. The test contains 19 sub-tasks in which different grips (five-finger grips, cylinder grips, tweezers grips), as well as gross motor skills are specifically assessed. In each of the 19 tasks, a score is given from 0-3, where high scores indicate good arm function. The total score (0-57) is the sum of the sub-scores. The test has shown promising measurement properties. For participants in the chronic and subacute phase after stroke, a change of 5.7 points (10%) is considered clinically important. Norwegian guidelines will be used in the study.
0+6+12 months after end of treatment period
Nine Hole Peg Test (NHPT)
Time Frame: 0+6+12 months after end of treatment period
NHPT is a simple test of fine motor skills that is recommended, among other things, for participants with stroke. Scoring is based on the time the patient spends in placing and removing nine small pieces in nine holes. Total time (maximum 50 seconds) and total number of pins are indicated. The test has shown satisfactory reliability and validity.
0+6+12 months after end of treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian Underwater Intervention (NUI)

Collaborators

Western Norway University of Applied Sciences
Helse-Bergen HF

Investigators

  • Principal Investigator: Tobba T Südmann, PhD, Western Norway University of Applied Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 20, 2020

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

December 20, 2021

Study Registration Dates

First Submitted

October 29, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (Actual)

November 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 27, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 305476

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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