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Completed

NCT Number: NCT01656317

Rehabilitation of Patients After 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

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Key information

Conditions

SAH

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early multidisciplinary rehabilitation

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.

Primary outcomes

  1. Glasgow Coma Scale (GCS)

    Time frame: up to 10 weeks

Secondary outcomes

  1. Glasgow Outcome Scale Extended (GOSE)

    Time frame: 3-6 months and 12 months after SAH

  2. Functional Independence Measure (FIM)

    Time frame: 3-6 months and 12 months after SAH

  3. Coma Recovery Scale (CRS)

    Time frame: 3-6 and 12 months after SAH

  4. Disability Rating Scale (DRS)

    Time frame: 3-6 and 12 months after SAH

  5. High Level Mobility Assessment Tool (HIMAT)

    Time frame: 3-6 and 12 months after SAH

Other outcomes

  1. Pain score on the Visual Analog Scale

    Time frame: 3-6 and 12 months after SAH

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Effect of Early Rehabilitation in Patients With Acute Subarachnoid Hemorrhage

Acronym: SAH

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Aug 2, 2012
Registry last updated
Mar 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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