Interdisciplinary Home Rehabilitation of Patients With Stroke. A Randomised Controlled Intervention Trial.
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|ClinicalTrials.gov Identifier: NCT00626353|
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : March 18, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Stroke||Other: Home-based rehabilitation Other: Standard care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Interdisciplinary Home Rehabilitation of Patients With Stroke. A Randomised Controlled Intervention Trial.|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
Patients treated by an interdisciplinary, intersectoral and interventional team responsible for providing home-based rehabilitation.
Other: Home-based rehabilitation
Rehabilitation at home during hospital stay and after discharge
Other Name: Rehabilitation at home
Active Comparator: Control
Control patients treated following standard care procedures in our department with no interference from the interventional team.
Other: Standard care
Standard care during hospital stay and in the municipality after discharge
Other Name: Regular rehabilitation stroke treatment
- modified Rankin Scale [ Time Frame: 90 days ]To investigate differences in the modified Rankin Scale among intervention and control patients at the inclusion time point and 90 days later.
- EuroQol-5D™ quality of life measurement [ Time Frame: 90 ]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 [ Time Frame: 90 ]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 [ Time Frame: 90 ]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 [ Time Frame: 90 ]To investigate differences in CT-50 Cognitive Test scores among intervention and control patients at inclusion time point and after 90 days.
- Body Mass Index [ Time Frame: 90 ]To investigate differences in Body Mass Index (BMI) scores among intervention and control patients at inclusion time point and after 90 days.
- Economy [ Time Frame: 90 ]To estimate differences in treatment associated costs among intervention and control patients at inclusion time point and after 90 days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626353
|University hospital of Gentofte|
|Hellerup, Denmark, 2900|
|Study Director:||Finn Roenholt, PhD||University Hospital of Copenhagen, Gentofte Hospital|