Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental, Neurological and Neurosurgery | UNKNOWN |
| Borsod-Abaúj-Zemplén County Central Hospital and University Teaching Hospital | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The goal of the randomized clinical trial is to examine the effect of early mobilization on primary and secondary outcomes in patients with subarachnoid hemorrhage caused by aneurysm rupture.
Researchers will compare early mobiliziation vs. standrad bed rest care.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early mobilization | Experimental | This group is mobilized in the intensive care unit by the institutional physiotherapist with the assistance of specialized personnel. Mobilization is carried out according to the Early Mobilization Protocol (EMP) Early mobilization protocol:
|
|
| Standard bed rest | Active Comparator | No early mobilization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early mobilization protocol | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disability in early mobilization group (EM) vs. standard care group (SC) - modified Rankin score | Outcome assessments will include: Modified Rankin Scale Disability is assessed by the modified Rankin Scale, dichotomized at a score of 0 to 3 versus 4 to 6 (6=death).Assessment is performed by a blinded investigator of the local study center by personal visit. | 14 day; 3 months |
| Disability in early mobilization group (EM) vs. standard care group (SC) - Extended Glasgow Outcome Scale | Extended Glasgow Outcome Scale Description of the neurological outcome by using extended Glasgow Outcome Score
Assessment is performed by a blinded investigator of the local study center by personal visit. | 14 day; 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of delayed cerebral ischemia (DCI) | Occurence of DCI after aneurysmal subarachnoid hemorrhage | 3-21 days |
| Onset of severity of macrovascular vasospasm | based on cerebral vasospasm grade Grade 0 All intracranial vessels show a physiological shape Grade 1 Vasospasm affects the A2, A1, and M2 segments Grade 2 Vasospasm expands to the M1 and terminal segment of the internal carotid artery Grade 3 Severe reduction in the intradural internal carotid artery with filiform A1 and M1 segments, which sometimes appears like a ghost (ghost sign) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Csecsei, MD. PhD | Contact | +0672535900 | csecsei.peter@pte.hu |
| Name | Affiliation | Role |
|---|---|---|
| Peter Csecsei, MD. PhD | University of Pecs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pecs | Recruiting | Pécs | Baranya | 7624 | Hungary |
Investigators will use external resources for an appropriate repository for their data
After study completion for 3 years.
upon reasonable request
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard care | Behavioral | During standard care, early mobilization does not take place in the intensive care unit; the patient receives only standard supportive care in bed rest. |
|
| Up to 14 days |
| Stay in the Intensive Care Unit (ICU) | Length of stay in the Intensive Care Unit (ICU) | Up to 28 days |
| Type of post-hospital discharge placement | home discharge, rehabilitation, chronic care, etc. | Up to 30 days |
| Readmission to the ICU | repeated ICU treatment following ward discharge | Up to 30 days |
| Occurrence of infection and its time in the intensive care unit | infection and its time in the intensive care unit | Up to 30 days |
| Barthel score | For assessing activities of daily living in patients with aneurysmal subarachnoid hemorrhage; ordinal scale rates bowel function, bladder function, grooming, toilet use, feeding independence, transfer independence, mobility, dressing ability, stair use, and bathing ability to tabulate a composite score ranging from 0 to 100. Score of 100 represents totally independent. Assessment is performed by a blinded investigator of the local study center by personal visit. | 14 day; 3 months |
| Functional Independence Measure (FIM) scale | The FIM's assessment of degree of disability depends on the patient's score in 18 categories, focusing on motor and cognitive function. Each category or item is rated on a 7-point scale (1 = <25% independence; total assistance required, 7 = 100% independence) Assessment is performed by a blinded investigator of the local study center by personal visit. | 14 day |
| Montreal Cognitive Assessment (MoCA) | MoCA scores range between 0 and 30. The MoCA is used for assessment for detecting cognitive impairment. A score of 26 or over is considered to be normal. Assessment is performed by a blinded investigator of the local study center by personal visit. | 14 day; 3 months |
| Hospital Anxiety and Depression Scale (HADS) | Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case. Assessment is performed by a blinded investigator of the local study center by personal visit. | 14 day; 3 months |
| Central Hospital of B.A.Z. County | Recruiting | Miskolc | BAZ | 3526 | Hungary |
|
| National Institute of Mental Health, Neurology, and Neurosurgery | Recruiting | Budapest | 1145 | Hungary |
|
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided