Hyperbaric Oxygen, Stroke
Conditions
Keywords
Hyperbaric Oxygen, Completed Stroke, Feasibility, Prospective
Brief summary
Prospective clinical assessment of 40 Hyperbaric Oxygen (HBO) treatments in 10 completed stroke patients.
Detailed description
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.
Interventions
DRUGHyperbaric oxygen
40 consecutive (5/7) sessions of hyperbaric oxygen
Sponsors
Hyperbaric Center Basel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with ischemic cortical stroke in chronic stage (≥ 3 months) with residual motor deficits confirmed by imaging with brain CT scan and/or brain MRI Informed consent
Exclusion criteria
* Neurological issue: * inability to understand the informed consent form * Hemiplegia * Hyperbaric issue: * Claustrophobia * inability to put on face mask * uncontrolled epilepsy * dementia or psychological disturbance * previous pneumothorax * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Rivermead mobility index (RMI) at 3 months | Change from Baseline 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 in Rivermead mobility index (RMI) at 8 weeks | Change from Baseline RMI at 8 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 in Rivermead mobility index (RMI) at 1 month | Change from Baseline 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 in National Institutes of Health Stroke Scale (NIHSS score) | Change from Baseline NIHSS Score at 3 months | 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 in Rivermead mobility index (RMI) at 2 weeks | Change from Baseline 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 in Rivermead mobility index (RMI) at 4 weeks | Change from Baseline 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 in Rivermead mobility index (RMI) at 6 weeks | Change from Baseline 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Acuity | Change from Baseline Visual Acuity at 3 months | Snellen chart. Visual acuity test from a distance of 6m. 1 is normal vision, 0 is blindness. Each eye is assessed. |
| Tympanic damage | From date of Start of HBOT until the date of End of HBOT | 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. |
Countries
Switzerland
Outcome results
None listed