Cerebrovascular AccidentNCT00241956
Impact of Diabetes and Glucose Control During Rehabilitation After Stroke
An observational study of Cerebrovascular Accident and Diabetes, run by Melbourne Health at 1 site in Australia.
Trial summary
To assess whether patients with diabetes have less clinical improvement during inpatient rehabilitation than those without diabetes and whether hyperglycaemia during rehabilitation is an adverse prognostic indicator. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrovascular Accident, Diabetes, Hyperglycemia
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2005to May 2006
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Stroke rehab patients
Who may be able to join
- Inpatient rehabilitation for acute stroke
Who cannot join
- Medical records unavailable
Trial locations and contacts
1 site in 1 country.
About this study
To assess whether patients with diabetes have less clinical improvement during inpatient rehabilitation than those without diabetes and whether hyperglycaemia during rehabilitation is an adverse prognostic indicator.
Read the detailed description
Patients with diabetes have a higher mortality rate and more severe disability from stroke compared to those without diabetes. Those with hyperglycaemia tend to progress to a larger final stroke size. Diabetes and hyperglycaemia may affect the ability of the patient to clinically improve, independent of the degree of initial impairment. We will perform a retrospective review of medical records of stroke patients admitted to an inpatient rehabilitation unit. We will compare outcomes of changes in disability scales (FIM and Barthel) from admission to discharge, length of stay and hospital events between those with and without diabetes. Amongst those with diabetes, we will also assess whether those with higher mean blood glucose levels during their inpatient rehabilitation stay have worse outcomes.
- Conditions
- Cerebrovascular Accident, Diabetes, Hyperglycemia
- Medical subject headings
- Stroke, Diabetes Mellitus, Hyperglycemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionMay 2006
- Study completionMay 2006
Why it stopped: poor data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Investigators
- Leo Rando, MBBS FRACP, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241956
- Sponsor's protocol ID
- 2004.246
- Status last verified
- Jul 2011
- First submitted
- 18 Oct 2005
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Diabetes and Glucose Control During Rehabilitation After Stroke
- ClinicalTrials.gov ID
- NCT00241956
- Acronym / sponsor ID
- 2004.246
- Conditions
- Cerebrovascular Accident, Diabetes, Hyperglycemia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: poor data collection
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- Oct 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 19 Oct 2005 (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.
To assess whether patients with diabetes have less clinical improvement during inpatient rehabilitation than those without diabetes and whether hyperglycaemia during rehabilitation is an adverse prognostic indicator.
Detailed description
Patients with diabetes have a higher mortality rate and more severe disability from stroke compared to those without diabetes. Those with hyperglycaemia tend to progress to a larger final stroke size. Diabetes and hyperglycaemia may affect the ability of the patient to clinically improve, independent of the degree of initial impairment. We will perform a retrospective review of medical records of stroke patients admitted to an inpatient rehabilitation unit. We will compare outcomes of changes in disability scales (FIM and Barthel) from admission to discharge, length of stay and hospital events between those with and without diabetes. Amongst those with diabetes, we will also assess whether those with higher mean blood glucose levels during their inpatient rehabilitation stay have worse outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Stroke rehab patients
Key inclusion criteria (1 listed)
- Inpatient rehabilitation for acute stroke
Key exclusion criteria (1 listed)
- Medical records unavailable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: poor data collection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
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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.
Leo Rando, MBBS FRACP principal investigator
Melbourne Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident and Diabetes, run by Melbourne Health at 1 site in Australia.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 21 Jul 2011. 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 Australia. 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 was stopped early (reason given: poor data collection). Results are not available in the source record.
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.
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 21 Jul 2011.