Clinical trial NCT00626353: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke
Keywords: Stroke
rehabilitation
motor recovery
cognition
quality of life
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: Ministry of the Interior and Health, Denmark
First posted: 2008-02-29
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

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

Primary outcomes:
measure: modified Rankin Scale
timeFrame: 90 days
Secondary outcomes:
measure: EuroQol-5D™ quality of life measurement
timeFrame: 90
measure: Barthel-100 Index
timeFrame: 90
measure: Motor Assessment Scale
timeFrame: 90
measure: CT-50 Cognitive Test
timeFrame: 90
Other outcomes:
measure: Body Mass Index
timeFrame: 90
measure: Economy
timeFrame: 90
Locations:
city: Hellerup
country: Denmark
facility: University hospital of Gentofte
Study officials:
affiliation: University Hospital of Copenhagen, Gentofte Hospital
name: Finn Roenholt, PhD
role: STUDY_DIRECTOR
References: