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

Acute Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626353
• Other study ID #: H-A-2007-0027
• Status: Completed
• Phase: N/A
• First received: February 20, 2008
• Last updated: March 17, 2014
• Start date: July 2007
• Est. completion date: August 2008

Study information

• Verified date: March 2014
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Other:
• Home-based rehabilitation
Rehabilitation at home during hospital stay and after discharge
• Standard care
Standard care during hospital stay and in the municipality after discharge

Locations

Country	Name	City	State
Denmark	University hospital of Gentofte	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	Ministry of the Interior and Health, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Mass Index	To investigate differences in Body Mass Index (BMI) scores among intervention and control patients at inclusion time point and after 90 days.	90	No
Other	Economy	To estimate differences in treatment associated costs among intervention and control patients at inclusion time point and after 90 days.	90	No
Primary	modified Rankin Scale	To investigate differences in the modified Rankin Scale among intervention and control patients at the inclusion time point and 90 days later.	90 days	No
Secondary	EuroQol-5D™ quality of life measurement	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	No
Secondary	Barthel-100 Index	To investigate differences in the Barthel-100 Index scores among intervention and control patients at the inclusion time point and 90 days later.	90	No
Secondary	Motor Assessment Scale	To investigate differences in Motor Assessment Scale test scores among intervention and control patients at inclusion time point and after 90 days.	90	No
Secondary	CT-50 Cognitive Test	To investigate differences in CT-50 Cognitive Test scores among intervention and control patients at inclusion time point and after 90 days.	90	No