Rehabilitation of Patients After Subarachnoid Hemorrhage (SAH)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tanja Karic, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01656317
First received: July 12, 2012
Last updated: October 17, 2014
Last verified: October 2014
  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 Phase
SAH
Other: Early multidisciplinary rehabilitation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effect of Early Rehabilitation in Patients With Acute Subarachnoid Hemorrhage

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Glasgow Coma Scale (GCS) [ Time Frame: up to 10 weeks ] [ Designated as safety issue: Yes ]

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

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

Estimated Enrollment: 160
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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.
Study First Received: July 12, 2012
Last Updated: October 17, 2014
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:
SAH
Early rehabilitation
Mobilisation

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

ClinicalTrials.gov processed this record on October 20, 2014