Hyperbaric Oxygen Therapy After Stroke - PILOT - Clinical Trial for Cerebral Stroke | NCT04149379

Back to results

Primary Purpose

Status

Withdrawn

Phase

Phase 2

Locations

Norway

Study Type

Interventional

Intervention

Hyperbaric oxygen

About this trial

This is an interventional treatment trial for Cerebral Stroke focused on measuring Stroke, Hyperbaric oxygen

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

NUI

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

One group of 6 patients undergoing 20 sessions of hyperbaric therapy at table 14/90.

Outcomes

Primary Outcome Measures

Improved physical and cognitive function in activities of daily living.

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.

Short Physical Performance Battery (SPPB)

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.

Grip strength

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.

Fatigue Severity Scale (FSC)

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.

Canadian Occupational Performance Measure (COPM)

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.

Action Research Arm Test (ARAT)

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.

Nine Hole Peg Test (NHPT)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04149379

First Posted

October 29, 2019

Last Updated

April 23, 2020

Sponsor

Norwegian Underwater Intervention (NUI)

Collaborators

Western Norway University of Applied Sciences, Helse-Bergen HF

1. Study Identification

Unique Protocol Identification Number

NCT04149379

Brief Title

Hyperbaric Oxygen Therapy After Stroke - PILOT

Official Title

Hyperbaric Oxygen Therapy After Cerebral Infarction - PILOT

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Because of the economic consequences of the COVID-19 pandemic 2020

Study Start Date

April 20, 2020 (Anticipated)

Primary Completion Date

August 31, 2021 (Anticipated)

Study Completion Date

December 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Norwegian Underwater Intervention (NUI)

Collaborators

Western Norway University of Applied Sciences, Helse-Bergen HF

4. Oversight

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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Stroke

Keywords

Stroke, Hyperbaric oxygen

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Single subject SSED

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Arm Description

One group of 6 patients undergoing 20 sessions of hyperbaric therapy at table 14/90.

Intervention Type

Drug

Intervention Name(s)

Hyperbaric oxygen

Intervention Description

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.

Primary Outcome Measure Information:

Title

Improved physical and cognitive function in activities of daily living.

Description

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.

Time Frame