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

This study has been completed.
Sponsor:
Collaborator:
Ministry of the Interior and Health, Denmark
Information provided by (Responsible Party):
Rune Skovgaard Rasmussen, PhD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00626353
First received: February 20, 2008
Last updated: March 17, 2014
Last verified: March 2014
  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-based rehabilitation
Other: Standard care

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:
  • modified Rankin Scale [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    To investigate differences in the modified Rankin Scale among intervention and control patients at the inclusion time point and 90 days later.


Secondary Outcome Measures:
  • EuroQol-5D™ quality of life measurement [ Time Frame: 90 ] [ Designated as safety issue: No ]
    To measure differences of perceived quality of life in the EuroQol-5D™ quality of life test (EQ-5D) among intervention and control patients at the inclusion time point and 90 days later.

  • Barthel-100 Index [ Time Frame: 90 ] [ Designated as safety issue: No ]
    To investigate differences in the Barthel-100 Index scores among intervention and control patients at the inclusion time point and 90 days later.

  • Motor Assessment Scale [ Time Frame: 90 ] [ Designated as safety issue: No ]
    To investigate differences in Motor Assessment Scale test scores among intervention and control patients at inclusion time point and after 90 days.

  • CT-50 Cognitive Test [ Time Frame: 90 ] [ Designated as safety issue: No ]
    To investigate differences in CT-50 Cognitive Test scores among intervention and control patients at inclusion time point and after 90 days.


Other Outcome Measures:
  • Body Mass Index [ Time Frame: 90 ] [ Designated as safety issue: No ]
    To investigate differences in Body Mass Index (BMI) scores among intervention and control patients at inclusion time point and after 90 days.

  • Economy [ Time Frame: 90 ] [ Designated as safety issue: No ]
    To estimate differences in treatment associated costs among intervention and control patients at inclusion time point and after 90 days.


Enrollment: 71
Study Start Date: July 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Patients treated by an interdisciplinary, intersectoral and interventional team responsible for providing home-based rehabilitation.
Other: Home-based rehabilitation
Rehabilitation at home during hospital stay and after discharge
Other Name: Rehabilitation at home
Active Comparator: Control
Control patients treated following standard care procedures in our department with no interference from the interventional team.
Other: Standard care
Standard care during hospital stay and in the municipality after discharge
Other Name: Regular rehabilitation stroke treatment

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626353

Locations
Denmark
University hospital of Gentofte
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Ministry of the Interior and Health, Denmark
Investigators
Study Director: Finn Roenholt, PhD University Hospital of Copenhagen, Gentofte Hospital
  More Information

No publications provided

Responsible Party: Rune Skovgaard Rasmussen, PhD, MA, PhD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT00626353     History of Changes
Other Study ID Numbers: H-A-2007-0027
Study First Received: February 20, 2008
Last Updated: March 17, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University Hospital, Gentofte, Copenhagen:
Stroke
rehabilitation
motor recovery
cognition
quality of life

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 August 26, 2014