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Rehabilitation of Patients After Subarachnoid Hemorrhage (SAH)

Primary Purpose

SAH

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Early multidisciplinary rehabilitation
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SAH focused on measuring SAH, Early rehabilitation, Mobilisation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Mobilisation of patients after SAH

Patients after SAH from 2011

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Glasgow Coma Scale (GCS)

Secondary Outcome Measures

Glasgow Outcome Scale Extended (GOSE)
Functional Independence Measure (FIM)
Coma Recovery Scale (CRS)
Disability Rating Scale (DRS)
High Level Mobility Assessment Tool (HIMAT)

Full Information

First Posted
July 12, 2012
Last Updated
March 14, 2017
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01656317
Brief Title
Rehabilitation of Patients After Subarachnoid Hemorrhage
Acronym
SAH
Official Title
Effect of Early Rehabilitation in Patients With Acute Subarachnoid Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2012 (Actual)
Primary Completion Date
February 27, 2014 (Actual)
Study Completion Date
December 20, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SAH
Keywords
SAH, Early rehabilitation, Mobilisation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobilisation of patients after SAH
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Patients after SAH from 2011
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Early multidisciplinary rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glasgow Coma Scale (GCS)
Time Frame
up to 10 weeks
Secondary Outcome Measure Information:
Title
Glasgow Outcome Scale Extended (GOSE)
Time Frame
3-6 months and 12 months after SAH
Title
Functional Independence Measure (FIM)
Time Frame
3-6 months and 12 months after SAH
Title
Coma Recovery Scale (CRS)
Time Frame
3-6 and 12 months after SAH
Title
Disability Rating Scale (DRS)
Time Frame
3-6 and 12 months after SAH
Title
High Level Mobility Assessment Tool (HIMAT)
Time Frame
3-6 and 12 months after SAH
Other Pre-specified Outcome Measures:
Title
Pain score on the Visual Analog Scale
Time Frame
3-6 and 12 months after SAH

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanja Karic, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27058204
Citation
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.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Article
Available IPD/Information URL
https://www.ncbi.nlm.nih.gov/pubmed/27494170
Available IPD/Information Identifier
DOI: 10.2340/16501977-2121
Available IPD/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.
Available IPD/Information Type
Article
Available IPD/Information URL
https://www.ncbi.nlm.nih.gov/pubmed/27058204
Available IPD/Information Identifier
DOI: 10.3171/2015.12.JNS151744
Available IPD/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.
Available IPD/Information Type
Article
Available IPD/Information URL
https://www.ncbi.nlm.nih.gov/pubmed/25264735
Available IPD/Information Identifier
10.3109/09638288.2014.966162
Available IPD/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.

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Rehabilitation of Patients After Subarachnoid Hemorrhage

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