NCT01656317

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 2, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2014

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2015

Completed
Last Updated

March 15, 2017

Status Verified

March 1, 2017

Enrollment Period

2.2 years

First QC Date

July 12, 2012

Last Update Submit

March 14, 2017

Conditions

SAH

Keywords

SAHEarly rehabilitationMobilisation

Outcome Measures

Primary Outcomes (1)

  • Glasgow Coma Scale (GCS)

    up to 10 weeks

Secondary Outcomes (5)

  • Glasgow Outcome Scale Extended (GOSE)

    3-6 months and 12 months after SAH

  • Functional Independence Measure (FIM)

    3-6 months and 12 months after SAH

  • Coma Recovery Scale (CRS)

    3-6 and 12 months after SAH

  • Disability Rating Scale (DRS)

    3-6 and 12 months after SAH

  • High Level Mobility Assessment Tool (HIMAT)

    3-6 and 12 months after SAH

Other Outcomes (1)

  • Pain score on the Visual Analog Scale

    3-6 and 12 months after SAH

Study Arms (2)

Mobilisation of patients after SAH

ACTIVE COMPARATOR

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

Patients after SAH from 2011

NO INTERVENTION

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.

Interventions

Early multidisciplinary rehabilitationOTHER

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.

Mobilisation of patients after SAH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0424, Norway

Location

Related Publications (1)

  • 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.

    PMID: 27058204DERIVED

Study Officials

  • Tanja Karic, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

July 12, 2012

First Posted

August 2, 2012

Study Start

January 1, 2012

Primary Completion

February 27, 2014

Study Completion

December 20, 2015

Last Updated

March 15, 2017

Record last verified: 2017-03

Locations

NO(1)