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| Name | Class |
|---|---|
| Ministry of the Interior and Health, Denmark | OTHER_GOV |
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Objective: To evaluate the effect of interdisciplinary home rehabilitation of patients with acute stroke. The trial seeks to evaluate:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients treated by an interdisciplinary, intersectoral and interventional team responsible for providing home-based rehabilitation. |
|
| Control | Active Comparator | Control patients treated following standard care procedures in our department with no interference from the interventional team. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based rehabilitation | Other | Rehabilitation at home during hospital stay and after discharge |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| EuroQol-5Dâ„¢ quality of life measurement | To measure differences of perceived quality of life in the EuroQol-5Dâ„¢ quality of life test (EQ-5D) among intervention and control patients at the inclusion time point and 90 days later. | 90 |
| Barthel-100 Index |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | To investigate differences in Body Mass Index (BMI) scores among intervention and control patients at inclusion time point and after 90 days. | 90 |
| Economy | To estimate differences in treatment associated costs among intervention and control patients at inclusion time point and after 90 days. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Finn Roenholt, PhD | University Hospital of Copenhagen, Gentofte Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital of Gentofte | Hellerup | 2900 | Denmark |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard care | Other | Standard care during hospital stay and in the municipality after discharge |
|
|
To investigate differences in the Barthel-100 Index scores among intervention and control patients at the inclusion time point and 90 days later.
| 90 |
| 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. | 90 |
| 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. | 90 |
| 90 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |