Acute StrokeNCT00626353
Interdisciplinary Home Rehabilitation of Patients With Stroke. A Randomised Controlled Intervention Trial.
A study testing Home-based rehabilitation in people with Acute Stroke, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Home-based rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2007to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Terminal care,
- Discharged from another department, Living in nursery home,
- Can not understand the Danish language,
- Memory difficulties
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Acute Stroke
- Being tested
- Home-based rehabilitation, Standard care
- Keywords
- Stroke, rehabilitation, motor recovery, cognition, quality of life
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based rehabilitationOther
Also called Rehabilitation at home
Rehabilitation at home during hospital stay and after discharge
Standard careOther
Also called Regular rehabilitation stroke treatment
Standard care during hospital stay and in the municipality after discharge
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients treated by an interdisciplinary, intersectoral and interventional team responsible for providing home-based rehabilitation. Receives: Other: Home-based rehabilitation |
| Control | Active comparator | Control patients treated following standard care procedures in our department with no interference from the interventional team. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (4)
EuroQol-5D™ quality of life measurement
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.
Measured: 90
Barthel-100 Index
To investigate differences in the Barthel-100 Index scores among intervention and control patients at the inclusion time point and 90 days later.
Measured: 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.
Measured: 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.
Measured: 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of the Interior and Health, Denmark
- Responsible party
- Principal investigator, Rune Skovgaard Rasmussen, PhD, University Hospital, Gentofte, Copenhagen
- Investigators
- Finn Roenholt, PhD, Study director, University Hospital of Copenhagen, Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626353
- Sponsor's protocol ID
- H-A-2007-0027
- Status last verified
- Mar 2014
- First submitted
- 20 Feb 2008
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Home Rehabilitation of Patients With Stroke. A Randomised Controlled Intervention Trial.
- ClinicalTrials.gov ID
- NCT00626353
- Acronym / sponsor ID
- H-A-2007-0027
- Conditions
- Acute Stroke
- Keywords
- Stroke, rehabilitation, motor recovery, cognition, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- Ministry of the Interior and Health, Denmark
- Study start
- Jul 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Home-based rehabilitationPatients treated by an interdisciplinary, intersectoral and interventional team responsible for providing home-based rehabilitation. |
| Control | Active comparator | Other: Standard careControl patients treated following standard care procedures in our department with no interference from the interventional team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Terminal care,
- Discharged from another department, Living in nursery home,
- Can not understand the Danish language,
- Memory difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based rehabilitationAlso: Rehabilitation at homeRehabilitation at home during hospital stay and after discharge | Other | Intervention |
| Standard careAlso: Regular rehabilitation stroke treatmentStandard care during hospital stay and in the municipality after discharge | Other | Control |
Primary outcome
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.
4 secondary outcomes
EuroQol-5D™ quality of life measurement
Time frame: 90
Barthel-100 Index
Time frame: 90
Motor Assessment Scale
Time frame: 90
CT-50 Cognitive Test
Time frame: 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Finn Roenholt, PhD study director
University Hospital of Copenhagen, Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based rehabilitation in people with Acute Stroke, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.