Rehabilitation of Patients After Subarachnoid Hemorrhage

SAH Clinical Trial

— SAH  

Official title:

Effect of Early Rehabilitation in Patients With Acute Subarachnoid Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656317
• Other study ID #: 2011/2189.
• Secondary ID: ID:2011/2189.
• Status: Completed
• Phase: N/A
• First received: July 12, 2012
• Last updated: March 14, 2017
• Start date: January 1, 2012
• Est. completion date: December 20, 2015

Study information

• Verified date: March 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: December 20, 2015
• Est. primary completion date: February 27, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• SAH
• Subarachnoid Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain score on the Visual Analog Scale		3-6 and 12 months after SAH
Primary	Glasgow Coma Scale (GCS)		up to 10 weeks
Secondary	Glasgow Outcome Scale Extended (GOSE)		3-6 months and 12 months after SAH
Secondary	Functional Independence Measure (FIM)		3-6 months and 12 months after SAH
Secondary	Coma Recovery Scale (CRS)		3-6 and 12 months after SAH
Secondary	Disability Rating Scale (DRS)		3-6 and 12 months after SAH
Secondary	High Level Mobility Assessment Tool (HIMAT)		3-6 and 12 months after SAH