Effect of hyperbaric oxygen therapy (HBOT) on patients with chronic neurological deficiency due to stroke.
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- National Institutes of Health Stroke Scale (NIHSS)
- Activities of daily living (ADL)
- Brain metabolism as visualized by SPECT
Secondary outcome
Quality of life evaluation, nine-hole peg test, and tap test.
Background summary
The positive randomized trial executed in Israel which was approved by the
Israelian ethics commitee.
Study objective
Effect of hyperbaric oxygen therapy (HBOT) on patients with chronic
neurological deficiency due to stroke.
Study design
Patients are randomized in hyperbaric oxygen or not with a cross-over after 3
months for the patients not having hyperbaric oxygen yet.
Study burden and risks
Patients will undergo 40x 1,5 hyperbaric oxygen treatment.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Patients with Ischemic or haemorrhagic stroke within 6-36 months
Exclusion criteria
- Dynamic neurologic improvement or worsening during the last month
- Had been treated with HBOT for any other reason prior to their inclusion
- Have any other indication for HBOT;
- Chest pathology incompatible with pressure changes;
- Inner ear disease;
- Patients suffering from claustrophobia;
- Inability to sign written informed consent.
- Smoking patients were not allowed to smoke during the study and if they could not comply with this demand they were excluded.
- Inability to sign informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67129.078.18 |