Overview

This trial is active, not recruiting.

Condition sah
Treatment early multidisciplinary rehabilitation
Phase phase 2/phase 3
Sponsor Oslo University Hospital
Start date January 2012
End date December 2015
Trial size 160 participants
Trial identifier NCT01656317, 2011/2189., ID:2011/2189.

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Arm
(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.
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 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.

Primary Outcomes

Measure
Glasgow Coma Scale (GCS)
time frame: up to 10 weeks

Secondary Outcomes

Measure
Glasgow Outcome Scale Extended (GOSE)
time frame: 3-6 months and 12 months after SAH
Functional Independence Measure (FIM)
time frame: 3-6 months and 12 months after SAH
Coma Recovery Scale (CRS)
time frame: 3-6 and 12 months after SAH
Disability Rating Scale (DRS)
time frame: 3-6 and 12 months after SAH
High Level Mobility Assessment Tool (HIMAT)
time frame: 3-6 and 12 months after SAH

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Effect of Early Rehabilitation in Patients With Acute Subarachnoid Hemorrhage
Principal investigator Tanja Karic, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Oslo University Hospital.