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

March 17, 2014 updated by: Rune Skovgaard Rasmussen, PhD, University Hospital, Gentofte, Copenhagen

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • University hospital of Gentofte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Regular rehabilitation stroke treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EuroQol-5D™ quality of life measurement
Time Frame: 90
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.
90
Barthel-100 Index
Time Frame: 90
To investigate differences in the Barthel-100 Index scores among intervention and control patients at the inclusion time point and 90 days later.
90
Motor Assessment Scale
Time Frame: 90
To investigate differences in Motor Assessment Scale test scores among intervention and control patients at inclusion time point and after 90 days.
90
CT-50 Cognitive Test
Time Frame: 90
To investigate differences in CT-50 Cognitive Test scores among intervention and control patients at inclusion time point and after 90 days.
90

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index
Time Frame: 90
To investigate differences in Body Mass Index (BMI) scores among intervention and control patients at inclusion time point and after 90 days.
90
Economy
Time Frame: 90
To estimate differences in treatment associated costs among intervention and control patients at inclusion time point and after 90 days.
90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

Ministry of the Interior and Health, Denmark

Investigators

  • Study Director: Finn Roenholt, PhD, University Hospital of Copenhagen, Gentofte Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 17, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-A-2007-0027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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