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Rehabilitation of Patients After Subarachnoid Hemorrhage (SAH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01656317
First Posted: August 2, 2012
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tanja Karic, Oslo University Hospital
  Purpose

The study's main objective will be to assess which effect early initiated rehabilitation has on the frequency of complications and the level of physical and cognitive functioning after aneurysmal subarachnoid hemorrhage (SAH).

To this end the following aspects will be investigated:

The frequency of complications (with special emphasis on pulmonary complications,thromboembolic events, cerebral vasospasm, unintended discontinuation of drains and lines)

  • Length of stay in hospitals and socio-economic impact
  • Physical and cognitive function in the early and chronic phase after SAH
  • Health-related quality of life and participation in society in the chronic phase

Condition Intervention
SAH Other: Early multidisciplinary rehabilitation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Early Rehabilitation in Patients With Acute Subarachnoid Hemorrhage

Resource links provided by NLM:


Further study details as provided by Tanja Karic, Oslo University Hospital:

Primary Outcome Measures:
  • Glasgow Coma Scale (GCS) [ Time Frame: up to 10 weeks ]

Secondary Outcome Measures:
  • Glasgow Outcome Scale Extended (GOSE) [ Time Frame: 3-6 months and 12 months after SAH ]
  • Functional Independence Measure (FIM) [ Time Frame: 3-6 months and 12 months after SAH ]
  • Coma Recovery Scale (CRS) [ Time Frame: 3-6 and 12 months after SAH ]
  • Disability Rating Scale (DRS) [ Time Frame: 3-6 and 12 months after SAH ]
  • High Level Mobility Assessment Tool (HIMAT) [ Time Frame: 3-6 and 12 months after SAH ]

Other Outcome Measures:
  • Pain score on the Visual Analog Scale [ Time Frame: 3-6 and 12 months after SAH ]

Enrollment: 171
Actual Study Start Date: January 1, 2012
Study Completion Date: December 20, 2015
Primary Completion Date: February 27, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mobilisation of patients after SAH

Patients which were treated after SAH in 2012 will receive early multidisciplinary rehabilitation consist of individualized stimulation and mobilisation.

Mobilisation will be initiated and completed according to mobilisations guidelines which are developed and adjusted to the patients in early stage after aneurysmal SAH.

Other: Early multidisciplinary rehabilitation

Multidisciplinary rehabilitation consist of individualized stimulation and mobilisation.

The multidisciplinary team consists of a physician, a nurse, a physiotherapist, an occupational therapist and a clinical neuropsychologist.

No Intervention: Patients after SAH from 2011
Patients after SAH from 2011 which did not receive early rehabilitation and mobilisation will be followed up 3-6 annd 12 months after SAH and outcome measures compared with patients from 2011.

Detailed Description:

Oslo University Hospital (OUS) is the primary hospital for Health Region South-East regarding treatment of patients with SAH. Approximately 120 patients are referred annually. OUS,Rikshospitalet, Dept of Neurosurgery offers 24/7 service of surgical and vascular aneurysm repair performed by a dedicated vascular team.

Patients admitted in 2012 are treated in accordance to the standard institutional protocol plus an early rehabilitation model adapted to SAH, while patients admitted in 2011 who did not receive any early rehabilitation, but apart from that were treated identically, serve as a control group.

All patients admitted to the intermediate unit at OUS in 2011 and 2012 with aneurysmal SAH and repaired aneurysm will be invited to participate in this study. Examination of the patients from both 2011 and 2012 will be performed as part of routine, neurosurgical follow- up which is in the early phase at 3-6 months and in the chronic phase at least 12 months post SAH. Exclusion criteria for participation in the study: unsecured ruptured aneurysm, symptomatic aneurysm without rupture, previous SAH or brain injury, diagnosis of a neurodegenerative disorder, patients from other health regions or tourists, patients that were treated at the intensive care unit (ICU )only.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients admitted to the intermediate unit at OUS in 2011 and 2012 with aneurysmal SAH and repaired aneurysm will be invited to participate in this study.

Exclusion Criteria:

  • Unsecured ruptured aneurysm,
  • Symptomatic aneurysm without rupture
  • Previous SAH or brain injury, diagnosis of a neurodegenerative disorder
  • Patients from other health regions or tourists
  • Patients that were treated at the intensive care unit (ICU )only.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656317


Locations
Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Tanja Karic, MD Oslo University Hospital
  More Information

Study Data/Documents: Article  This link exits the ClinicalTrials.gov site
Identifier: DOI: 10.2340/16501977-2121

Impact of early mobilization and rehabilitation on global functional outcome one year after aneurysmal subarachnoid hemorrhage.

Karic T1,2, Røe C1,3, Nordenmark TH1, Becker F4,3, Sorteberg W2, Sorteberg A2,3.


Article  This link exits the ClinicalTrials.gov site
Identifier: DOI: 10.3171/2015.12.JNS151744

J Neurosurg. 2017 Feb;126(2):518-526. doi: 10.3171/2015.12.JNS151744. Epub 2016 Apr 8.

Effect of early mobilization and rehabilitation on complications in aneurysmal subarachnoid hemorrhage.

Karic T1,2, Røe C1,3, Nordenmark TH1, Becker F4,3, Sorteberg W2, Sorteberg A2,3.


Article  This link exits the ClinicalTrials.gov site
Identifier: 10.3109/09638288.2014.966162

Disabil Rehabil. 2015;37(16):1446-54. doi: 10.3109/09638288.2014.966162. Epub 2014 Sep 29.

Early rehabilitation in patients with acute aneurysmal subarachnoid hemorrhage.

Karic T1, Sorteberg A, Haug Nordenmark T, Becker F, Roe C.



Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tanja Karic, medical doctor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01656317     History of Changes
Other Study ID Numbers: 2011/2189.
ID:2011/2189. ( Other Grant/Funding Number: Oslo University Hospital )
First Submitted: July 12, 2012
First Posted: August 2, 2012
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tanja Karic, Oslo University Hospital:
SAH
Early rehabilitation
Mobilisation

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases