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

NCT ID: NCT00626353

Last Updated: 2014-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Home-based rehabilitation

Intervention Type OTHER

Rehabilitation at home during hospital stay and after discharge

Control

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

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type OTHER

Standard care during hospital stay and in the municipality after discharge

Interventions

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Home-based rehabilitation

Rehabilitation at home during hospital stay and after discharge

Intervention Type OTHER

Standard care

Standard care during hospital stay and in the municipality after discharge

Intervention Type OTHER

Other Intervention Names

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Rehabilitation at home Regular rehabilitation stroke treatment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of the Interior and Health, Denmark

OTHER_GOV

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Rune Skovgaard Rasmussen, PhD

MA, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Finn Roenholt, PhD

Role: STUDY_DIRECTOR

University Hospital of Copenhagen, Gentofte Hospital

Locations

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University hospital of Gentofte

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-A-2007-0027

Identifier Type: -

Identifier Source: org_study_id

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