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Prospective clinical assessment of 40 Hyperbaric Oxygen (HBO) treatments in 10 completed stroke patients.
10 patients having suffered a stroke and having being rehabilitated will be treated with 40 consecutive Hyperbaric Oxygen Treatment (HBOT) after a minimal delay of 3 months after stroke. They will be neurologically assessed before and 3 months after HBOT. Rivermead mobility index will be also assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stroke patients | Experimental | 40 consecutive sessions of hyperbaric oxygen will be administered at a pressure of 2 absolute atmosphere (ATA) to 10 patients. If there are drop outs, recruitment will be continued until a total of 10 patients with at least 30 sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric oxygen | Drug | 40 consecutive (5/7) sessions of hyperbaric oxygen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in National Institutes of Health Stroke Scale (NIHSS score) | Neurological assessment before and after HBOT. Composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0 (0 is better). | Change from Baseline NIHSS Score at 3 months |
| Change in Rivermead mobility index (RMI) at 2 weeks | Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months. | Change from Baseline RMI at 2 weeks |
| Change in Rivermead mobility index (RMI) at 4 weeks | Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months. | Change from Baseline RMI at 4 weeks |
| Change in Rivermead mobility index (RMI) at 6 weeks | Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months. | Change from Baseline RMI at 6 weeks |
| Change in Rivermead mobility index (RMI) at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tympanic damage | Digital photography before and after each daily HBOT session, that means before and after each compression/decompression in the hyperbaric chamber, to detect any ear lesion. | From date of Start of HBOT until the date of End of HBOT |
| Change in Visual Acuity |
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Inclusion Criteria:
Informed consent
Exclusion Criteria:
Neurological issue:
Hyperbaric issue:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Gelsomino, med pract | Druckkammerzentrum Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Druckkammerzentrum Basel | Basel | 4057 | Switzerland |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months.
| Change from Baseline RMI at 8 weeks |
| Change in Rivermead mobility index (RMI) at 1 month | Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months. | Change from Baseline RMI at 1 month |
| Change in Rivermead mobility index (RMI) at 3 months | Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months. | Change from Baseline RMI at 3 months |
Snellen chart. Visual acuity test from a distance of 6m. 1 is normal vision, 0 is blindness. Each eye is assessed. |
| Change from Baseline Visual Acuity at 3 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |