Early Supported Discharge After Stroke in Bergen

Completed

Phase N/A Results N/A

Trial Description

The main purpose of this study is to evaluate the benefit of early supported discharge (ESD) in rehabilitation of stroke patients in two different outpatient modalities.
In a collaborating study, changes in physical function as well as the patients' own perception of physical function, pain and fatigue will be studied. In further collaborating studies, health economics and organizational issues will also be evaluated.

Detailed Description

Early supported discharge (ESD) seems to be at least as effective as hospital rehabilitation after stroke, and possibly better. In this study patients with recent stroke will be randomized to one of three different treatment arms:
- ESD with treatment at a day institution until 4 hrs. per day for up to 5 weeks
- ESD with treatment in the patients' home until 4 hrs. per day for up to 5 weeks
- Rehabilitation treatment "as usual", with a longer hospital stay, but without any specific treatment or follow-up after discharge
The patients in the two ESD arms will in addition be followed closely by a multidisciplinary coordinating team during the stay in hospital and the 5 week period of treatment after discharge, and they will be offered follow-ups at 3 and 6 months after inclusion into the study.
Patients in all 3 arms will be systematically examined with a set of measuring instruments as well as objective physical and function tests. This will be performed at inclusion and at 3, 6, 12 and 24 months after inclusion.
In the collaborating study by physiotherapist Bente Gjelsvik a comparison between changes in trunk control, balance, walking and ADL 3 months post stroke, as well as the patients' perceptions of physical function, pain and fatigue, will be the main focus. To assess function, functional change and possible differences between different interventions, there is a need for reliable and valid outcome measures. As a basis for the use of the outcome measure Trunk Impairment Scale (TIS) in this study, the TIS has been translated into Norwegian, Trunk Impairment Scale - Norwegian version (TIS-NV) and will be examined for measurement properties using data from the above study as well as data from patients with brain damage recruited from the Department of Physical Rehabilitation Medicine, Haukeland University Hospital. An examination of a possible connection between localisation and size of the stroke and trunk control will also be performed, as characteristics of the stroke may have therapeutic implications for the choice of intervention for the individual patient. The research questions for the planned doctoral thesis for Bente Gjelsvik are therefore as follows:
1. Is the TIS-NV reliable and valid in patients with brain damage?
2. Are changes in trunk control, balance, walking and daily activities, as well as pain and fatigue 3 months post stroke different in patients who have received interventions from different courses of rehabilitation in the study "Early supported discharge after stroke in Bergen"? To which degree do the patients perceive problems related to balance, physical activity, walking, pain and fatigue?
3. Is there a correlation between localization and size of the stroke as measured by magnetic tomography, and the patients' trunk control? Are initial localization and size of the stroke predictive for the patients' trunk control 3 months post stroke?
Another collaborating project is carried out by PhD candidate Hedda Døli (Language outcome after stroke: lesion location, prognosis and consequences).
The aim of her first study in the PhD project is to investigate the relationship between lesion location and aphasia severity one week post-stroke. Thereafter a follow-up study of the same patients 12 months post-stroke investigates the prognosis of aphasia and the variables that may influence recovery. In the third study the aim is to investigate the health-related quality of life and the occurrence of depression in patients with aphasia.

Conditions

Interventions

  • Standard Medical Care Procedure
    Intervention Desc: per the National Guidelines for Stroke.
  • Early supported discharge (ESD) Behavioral
    Intervention Desc: Early supported discharge with day institution rehabilitation. ESD with treatment at a day institution until 4 hrs. per day for up to 5 weeks.
  • Early supported discharge Behavioral
    Intervention Desc: Early supported discharge with home rehabilitation. ESD with treatment in the patients' home until 4 hrs. per day for up to 5 weeks.
  • Early supported discharge with day institution rehabilitation Other
    Intervention Desc: Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in a day institution
    ARM 1: Kind: Experimental
    Label: Day institution rehabilitation
    Description: Discharge from the hospital to the patients' homes as soon as possible, supported by an out-patient ambulatory coordinating multidisciplinary team. The patients will be offered rehabilitation in a day institution, and multidisciplinary policlinical follow-ups will be performed 3 and 6 months after inclusion.
  • Early supported discharge with home rehabilitation Other
    Intervention Desc: Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in the patient's home
    ARM 1: Kind: Experimental
    Label: Home rehabilitation
    Description: Discharge from the hospital to the patients' homes as soon as possible, supported by an out-patient ambulatory coordinating multidisciplinary team. The patients will be offered rehabilitation treatment in their homes, and multidisciplinary policlinical follow-ups will be performed 3 and 6 months after inclusion.
  • Early supported discharge with day unit rehabilitation Other
    Intervention Desc: Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in a day unit
    ARM 1: Kind: Experimental
    Label: Day unit rehabilitation
    Description: Discharge from the hospital to the patients' homes as soon as possible, supported by an out-patient ambulatory coordinating multidisciplinary team. The patients will be offered rehabilitation in a day unit, and multidisciplinary policlinical follow-ups will be performed 3 and 6 months after inclusion.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Patient Involvement

Patients with recent stroke will be randomized to one of three different treatment arms: 1) ESD with treatment at a day institution until 4 hrs. per day for up to 5 weeks; 2) ESD with treatment in the patients' home until 4 hrs. per day for up to 5 weeks; or 3)rehabilitation treatment "as usual", with a longer hospital stay, but without any specific treatment or follow-up after discharge.

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin Scale
Primary MRS 6 months No
Secondary NIHSS 3, 6 and 12 months No
Secondary BI 3, 6, 12 and 24 months No
Secondary AMPS 3 and 6 months No
Secondary TIS 3 and 6 months No
Secondary SIS 12 months No
Secondary RSS 12 months No
Secondary PGIC 12 and 24 months No
Secondary SF-36 12 and 24 months No
Secondary PASS (Postural Assessment Scale for Stroke) 3 and 6 months No
Secondary 5mTW (5 meter Timed Walk) 3 and 6 months No
Secondary TUG (Timed Up and Go) 3 and 6 months No
Secondary NRS (Numeric Rating Scale) 3 and 6 months No
Secondary Norwegian Basic Test for Aphasia 3 and 12 months No

Sponsors