Rehabilitation of Patients After Subarachnoid Hemorrhage (SAH)

March 14, 2017 updated by: Tanja Karic, Oslo University Hospital

Effect of Early Rehabilitation in Patients With Acute Subarachnoid Hemorrhage

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

171

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glasgow Coma Scale (GCS)
Time Frame: up to 10 weeks
up to 10 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Pain score on the Visual Analog Scale
Time Frame: 3-6 and 12 months after SAH
3-6 and 12 months after SAH

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Tanja Karic, MD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

February 27, 2014

Study Completion (Actual)

December 20, 2015

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

July 31, 2012

First Posted (Estimate)

August 2, 2012

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 14, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/2189.
  • ID:2011/2189. (Other Grant/Funding Number: Oslo University Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Study Data/Documents

  1. Article
    Information identifier: DOI: 10.2340/16501977-2121
    Information comments:

    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.

  2. Article
    Information identifier: DOI: 10.3171/2015.12.JNS151744
    Information comments:

    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.

  3. Article
    Information identifier: 10.3109/09638288.2014.966162
    Information comments:

    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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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