Hyperbaric Oxygen Therapy After Stroke - PILOT

• Status: Withdrawn
• Trial end date: 2021-12-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norwegian Underwater Intervention (NUI)
• Collaborators: Helse-Bergen HF; Western Norway University of Applied Sciences

Criteria

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