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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University Hospital, Gentofte, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00626353
First received: February 20, 2008
Last updated: February 28, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention
Acute Stroke
Other: Home rehabilitation
Other: Regular rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Interdisciplinary Home Rehabilitation of Patients With Stroke. A Randomised Controlled Intervention Trial.

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Can early home rehabilitation affect the degree of independence, quality of life and the possibility of discharge to own home and influence the length of admission at a rehabilitation centre in the municipality and readmission to hospital [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To what extend can home rehabilitation be implemented according to finances? [ Time Frame: 180 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Other: Home rehabilitation
Home rehabilitation during hospital stay and after discharge
Active Comparator: 2 Other: Regular rehabilitation
Regular rehabilitation during hospital stay and in the municipality after discharge

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626353

Locations
Denmark
University hospital of Gentofte Recruiting
Hellerup, Denmark, 2900
Contact: Finn Roenholt, PhD     +4539773555     firoha02@geh.regionh.dk    
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
  More Information

No publications provided

Responsible Party: Finn Roenholt, University Hospital of Gentofte
ClinicalTrials.gov Identifier: NCT00626353     History of Changes
Other Study ID Numbers: H-A-2007-0027
Study First Received: February 20, 2008
Last Updated: February 28, 2008
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 23, 2013