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Completed

NCT Number: NCT00626353

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

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.

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of Gentofte

Hellerup, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based rehabilitation

Other

Rehabilitation at home during hospital stay and after discharge

Other names: Rehabilitation at home

Standard care

Other

Standard care during hospital stay and in the municipality after discharge

Other names: Regular rehabilitation stroke treatment

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

  2. Economy

    Time frame: 90

    To estimate differences in treatment associated costs among intervention and control patients at inclusion time point and after 90 days.

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • Ministry of the Interior and Health, Denmark

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 29, 2008
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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