search
Back to results

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

Primary Purpose

Acute Stroke

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Home-based rehabilitation
Standard care
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Stroke focused on measuring Stroke, rehabilitation, motor recovery, cognition, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University hospital of Gentofte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Patients treated by an interdisciplinary, intersectoral and interventional team responsible for providing home-based rehabilitation.

Control patients treated following standard care procedures in our department with no interference from the interventional team.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
February 20, 2008
Last Updated
March 17, 2014
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Ministry of the Interior and Health, Denmark
search

1. Study Identification

Unique Protocol Identification Number
NCT00626353
Brief Title
Interdisciplinary Home Rehabilitation of Patients With Stroke. A Randomised Controlled Intervention Trial.
Official Title
Interdisciplinary Home Rehabilitation of Patients With Stroke. A Randomised Controlled Intervention Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Ministry of the Interior and Health, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objective: To evaluate the effect of interdisciplinary home rehabilitation of patients with acute stroke. The trial seeks to evaluate: 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? 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? 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
Stroke, rehabilitation, motor recovery, cognition, quality of life

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients treated by an interdisciplinary, intersectoral and interventional team responsible for providing home-based rehabilitation.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control patients treated following standard care procedures in our department with no interference from the interventional team.
Intervention Type
Other
Intervention Name(s)
Home-based rehabilitation
Other Intervention Name(s)
Rehabilitation at home
Intervention Description
Rehabilitation at home during hospital stay and after discharge
Intervention Type
Other
Intervention Name(s)
Standard care
Other Intervention Name(s)
Regular rehabilitation stroke treatment
Intervention Description
Standard care during hospital stay and in the municipality after discharge
Primary Outcome Measure Information:
Title
modified Rankin Scale
Description
To investigate differences in the modified Rankin Scale among intervention and control patients at the inclusion time point and 90 days later.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
EuroQol-5D™ quality of life measurement
Description
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.
Time Frame
90
Title
Barthel-100 Index
Description
To investigate differences in the Barthel-100 Index scores among intervention and control patients at the inclusion time point and 90 days later.
Time Frame
90
Title
Motor Assessment Scale
Description
To investigate differences in Motor Assessment Scale test scores among intervention and control patients at inclusion time point and after 90 days.
Time Frame
90
Title
CT-50 Cognitive Test
Description
To investigate differences in CT-50 Cognitive Test scores among intervention and control patients at inclusion time point and after 90 days.
Time Frame
90
Other Pre-specified Outcome Measures:
Title
Body Mass Index
Description
To investigate differences in Body Mass Index (BMI) scores among intervention and control patients at inclusion time point and after 90 days.
Time Frame
90
Title
Economy
Description
To estimate differences in treatment associated costs among intervention and control patients at inclusion time point and after 90 days.
Time Frame
90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Finn Roenholt, PhD
Organizational Affiliation
University Hospital of Copenhagen, Gentofte Hospital
Official's Role
Study Director
Facility Information:
Facility Name
University hospital of Gentofte
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs