Rehabilitation of Patients After Subarachnoid Hemorrhage

NCT ID: NCT01656317

Last Updated: 2017-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-01

Study Completion Date

2015-12-20

Brief Summary

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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

Detailed Description

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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.

Conditions

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SAH

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Early multidisciplinary rehabilitation

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tanja Karic

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tanja Karic, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

References

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Karic T, Roe C, Nordenmark TH, Becker F, Sorteberg W, Sorteberg A. Effect of early mobilization and rehabilitation on complications in aneurysmal subarachnoid hemorrhage. J Neurosurg. 2017 Feb;126(2):518-526. doi: 10.3171/2015.12.JNS151744. Epub 2016 Apr 8.

Reference Type DERIVED
PMID: 27058204 (View on PubMed)

Study Documents

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Document Type: Article

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.

View Document

Document Type: Article

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.

View Document

Document Type: Article

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.

View Document

Other Identifiers

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ID:2011/2189.

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2011/2189.

Identifier Type: -

Identifier Source: org_study_id

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