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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00626353
Enrollment
71
Registered
2008-02-29
Start date
2007-07-31
Completion date
2008-08-31
Last updated
2014-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Stroke

Keywords

Stroke, rehabilitation, motor recovery, cognition, quality of life

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.

Interventions

Rehabilitation at home during hospital stay and after discharge

OTHERStandard care

Standard care during hospital stay and in the municipality after discharge

Sponsors

Ministry of the Interior and Health, Denmark
CollaboratorOTHER_GOV
University Hospital, Gentofte, Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
modified Rankin Scale90 daysTo investigate differences in the modified Rankin Scale among intervention and control patients at the inclusion time point and 90 days later.

Secondary

MeasureTime frameDescription
EuroQol-5D™ quality of life measurement90To 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 Index90To investigate differences in the Barthel-100 Index scores among intervention and control patients at the inclusion time point and 90 days later.
Motor Assessment Scale90To investigate differences in Motor Assessment Scale test scores among intervention and control patients at inclusion time point and after 90 days.
CT-50 Cognitive Test90To investigate differences in CT-50 Cognitive Test scores among intervention and control patients at inclusion time point and after 90 days.

Other

MeasureTime frameDescription
Body Mass Index90To investigate differences in Body Mass Index (BMI) scores among intervention and control patients at inclusion time point and after 90 days.
Economy90To estimate differences in treatment associated costs among intervention and control patients at inclusion time point and after 90 days.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026