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Clinical Trials/NCT00626353
NCT00626353
Completed
N/A

Interdisciplinary Home Rehabilitation of Patients With Stroke. A Randomised Controlled Intervention Trial.

University Hospital, Gentofte, Copenhagen1 site in 1 country71 target enrollmentJuly 2007
ConditionsAcute Stroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Stroke
Sponsor
University Hospital, Gentofte, Copenhagen
Enrollment
71
Locations
1
Primary Endpoint
modified Rankin Scale
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Objective: To evaluate the effect of interdisciplinary home rehabilitation of patients with acute stroke. The trial seeks to evaluate:

  1. Can early home rehabilitation affect the degree of independence (motor capacity, activities of daily living and cognitive status), quality of life and the possibility of discharge to own home?
  2. Can home rehabilitation influence the length of admission at a rehabilitation centre in the municipality, readmission to hospital, the use of healthcare services and death?
  3. To what extend can home rehabilitation be implemented according to finances? Materials and methods: Patients at the age 18 years or more admitted to the stroke unit at the University Hospital of Gentofte. The patients were eligible when meeting the following criteria: symptoms of stroke, need of rehabilitation tree days after admission, living in own home in the Municipality of Gentofte, Lyngby-Taarbaek or Rudersdal and Modified Rankin Score between 0 and 3.

The trial was conducted as a randomised controlled trial. The control group patients were rehabilitated according to normal procedure. The intervention group patients were rehabilitated according to normal procedure and were additionally rehabilitated at home during admission and four weeks after discharge.

Detailed Description

Objectives were to assess the efficacy of home-based stroke rehabilitation compared to standard care in stroke patients using an interventional, randomised, safety/efficacy open-label trial and parallel assignment. The setting was single-center, stroke unit at the University Hospital of Copenhagen, Gentofte, although patients were recruited through a collaboration of several municipalities. Participants were eligible patients with a clinical diagnosis of stroke and focal neurological deficits hospitalised in a stroke unit for more than three days and in need of rehabilitation. Interventions patients were randomised to home-based rehabilitation during hospitalization and for up to 4 weeks after discharge to replace part of usual treatment and rehabilitation services. Control patients received treatment and rehabilitation following usual guidelines for the treatment of stroke patients. Main outcome measures 90 days post-stroke, modified Rankin Scale, and motor rehabilitation, cognitive abilities, quality of life and treatment-associated economy as secondary outcomes.

Registry
clinicaltrials.gov
Start Date
July 2007
End Date
August 2008
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Gentofte, Copenhagen
Responsible Party
Principal Investigator
Principal Investigator

Rune Skovgaard Rasmussen, PhD

MA, PhD

University Hospital, Gentofte, Copenhagen

Eligibility Criteria

Inclusion Criteria

  • 18 years or more,
  • Symptoms of stroke,
  • Need of rehabilitation tree days after admission,
  • Living in own home,
  • Modified Rankin Score between 0 and 3

Exclusion Criteria

  • Terminal care,
  • Discharged from another department, Living in nursery home,
  • Can not understand the Danish language,
  • Memory difficulties

Outcomes

Primary Outcomes

modified Rankin Scale

Time Frame: 90 days

To investigate differences in the modified Rankin Scale among intervention and control patients at the inclusion time point and 90 days later.

Secondary Outcomes

  • Motor Assessment Scale(90)
  • CT-50 Cognitive Test(90)
  • EuroQol-5D™ quality of life measurement(90)
  • Barthel-100 Index(90)

Study Sites (1)

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