Interdisciplinary Home Rehabilitation of Patients With Stroke. A Randomised Controlled Intervention Trial.
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University Hospital, Gentofte, Copenhagen.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital, Gentofte, Copenhagen
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00626353
First received: February 20, 2008
Last updated: February 28, 2008
Last verified: February 2008
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Purpose
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 | Intervention |
|---|---|
|
Acute Stroke |
Other: Home rehabilitation Other: Regular rehabilitation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Interdisciplinary Home Rehabilitation of Patients With Stroke. A Randomised Controlled Intervention Trial. |
Resource links provided by NLM:
Further study details as provided by University Hospital, Gentofte, Copenhagen:
Primary Outcome Measures:
- Can early home rehabilitation affect the degree of independence, quality of life and the possibility of discharge to own home and influence the length of admission at a rehabilitation centre in the municipality and readmission to hospital [ Time Frame: 180 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To what extend can home rehabilitation be implemented according to finances? [ Time Frame: 180 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Other: Home rehabilitation
Home rehabilitation during hospital stay and after discharge
|
| Active Comparator: 2 |
Other: Regular rehabilitation
Regular rehabilitation during hospital stay and in the municipality after discharge
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626353
Locations
| Denmark | |
| University hospital of Gentofte | Recruiting |
| Hellerup, Denmark, 2900 | |
| Contact: Finn Roenholt, PhD +4539773555 firoha02@geh.regionh.dk | |
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
More Information
No publications provided
| Responsible Party: | Finn Roenholt, University Hospital of Gentofte |
| ClinicalTrials.gov Identifier: | NCT00626353 History of Changes |
| Other Study ID Numbers: | H-A-2007-0027 |
| Study First Received: | February 20, 2008 |
| Last Updated: | February 28, 2008 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 23, 2013