StrokeNCT04700982
Does the Length of Hospital Stay for Rehabilitation Affect Functional Outcomes in Stroke Patients
An observational study of Stroke, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to evaluate whether the length of hospital stay for rehabilitation affects functional outcomes of stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Based on the length of hospital stay
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Oct 2020to 1 Nov 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with a stroke who received rehabilitation in an inpatient clinic between 2010 and 2013
Who may be able to join
- Clinical diagnosis of stroke
- must be able to receive rehabilitation in an inpatient clinic between 2010 and 2013
Who cannot join
- previous history of stroke,
- other neurological diseases,
- amputation,
- severe arthritis
- undergoing hemodialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Length of Hospital Stay for Rehabilitation Affect Functional Outcomes in Stroke Patients: A Retrospective Study
The purpose of this study was to evaluate whether the length of hospital stay for rehabilitation affects functional outcomes of stroke patients.
Read the detailed description
The medical records of patients who were admitted to a rehabilitation unit were analyzed retrospectively. The functional output, the level of spasticity, and the level of motor development at admission and discharge will be determined using the Functional Independence Measure instrument, the Modified Ashworth Scale, and the Brunnstrom test, respectively. Based on the length of hospital stay, patients will be divided into two groups: hospital stays ≤ 3 months (Group 1) and > 3 months (Group 2). Clinical features and functional output will be compared between the groups.
- Conditions
- Stroke
- Being tested
- Based on the length of hospital stay
- Keywords
- Neurological Rehabilitation, Stroke, Rehabilitation Outcome
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Based on the length of hospital stayOther
Based on the length of hospital stay, patients were divided into two groups: hospital stays ≤ 3 months (Group 1) and > 3 months (Group 2).Clinical features and functional output will be then compared between the groups.
| Study group | Role | What they receive |
|---|---|---|
| Based on the length of hospital stay | Based on the length of hospital stay, patients were divided into two groups: hospital stays ≤ 3 months (Group 1) and > 3 months (Group 2). Receives: Other: Based on the length of hospital stay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical features and Functional Independence Measure instrument, the Modified Ashworth Scale, and the Brunnstrom test outcomes will be then compared between the groups.
Demographic features, clinical features and Functional Independence Measure (FIM) instrument, the Modified Ashworth Scale (MAS), and the Brunnstrom test outcomes will be documented for all patients. The FIM includes 18 items with higher scores indicating greater independence. The motor development of the upper extremity, hand, and lower extremity will be evaluated using the Brunnstrom test with higher stages indicating greater development. The degree of spasticity of the upper and lower extremity muscles will be assessed using the MAS with high stage indicating greater spasticity.
All patients will be divided into two groups based on length of hospital stay. Clinical features, demographic features and FIM, MAS, and the Brunnstrom test outcomes will be then compared between the groups. All data for normality were tested with Kolmogorov-Smirnov tests. Mann-Whitney U tests will be used for comparison of the differences between the two groups.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start7 Oct 2020
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Çiftçi Tepeli, Kırklareli University
- Investigators
- betül çiftçi tepeli, Principal investigator, Kırklareli University School of Health Department of Physical Medicine and Rehabilitiation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700982
- Sponsor's protocol ID
- 94603339-604.01.02
- Status last verified
- Dec 2020
- First submitted
- 28 Dec 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Foulkes MA, Wolf PA, Price TR, Mohr JP, Hier DB. The Stroke Data Bank: design, methods, and baseline characteristics. Stroke. 1988 May;19(5):547-54. doi: 10.1161/01.str.19.5.547.
PubMed 3363586Balaban B, Tok F, Yavuz F, Yasar E, Alaca R. Early rehabilitation outcome in patients with middle cerebral artery stroke. Neurosci Lett. 2011 Jul 12;498(3):204-7. doi: 10.1016/j.neulet.2011.05.009. Epub 2011 May 11.
PubMed 21600267Hebert D, Lindsay MP, McIntyre A, Kirton A, Rumney PG, Bagg S, Bayley M, Dowlatshahi D, Dukelow S, Garnhum M, Glasser E, Halabi ML, Kang E, MacKay-Lyons M, Martino R, Rochette A, Rowe S, Salbach N, Semenko B, Stack B, Swinton L, Weber V, Mayer M, Verrilli S, DeVeber G, Andersen J, Barlow K, Cassidy C, Dilenge ME, Fehlings D, Hung R, Iruthayarajah J, Lenz L, Majnemer A, Purtzki J, Rafay M, Sonnenberg LK, Townley A, Janzen S, Foley N, Teasell R. Canadian stroke best practice recommendations: Stroke rehabilitation practice guidelines, update 2015. Int J Stroke. 2016 Jun;11(4):459-84. doi: 10.1177/1747493016643553. Epub 2016 Apr 14.
PubMed 27079654
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Length of Hospital Stay for Rehabilitation Affect Functional Outcomes in Stroke Patients: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04700982
- Acronym / sponsor ID
- 94603339-604.01.02
- Conditions
- Stroke
- Keywords
- Neurological Rehabilitation, Stroke, Rehabilitation Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 8 Jan 2021 (actual)
- 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.
The purpose of this study was to evaluate whether the length of hospital stay for rehabilitation affects functional outcomes of stroke patients.
Detailed description
The medical records of patients who were admitted to a rehabilitation unit were analyzed retrospectively. The functional output, the level of spasticity, and the level of motor development at admission and discharge will be determined using the Functional Independence Measure instrument, the Modified Ashworth Scale, and the Brunnstrom test, respectively. Based on the length of hospital stay, patients will be divided into two groups: hospital stays ≤ 3 months (Group 1) and > 3 months (Group 2). Clinical features and functional output will be compared between the groups.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Based on the length of hospital stay | – | Other: Based on the length of hospital stayBased on the length of hospital stay, patients were divided into two groups: hospital stays ≤ 3 months (Group 1) and > 3 months (Group 2). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a stroke who received rehabilitation in an inpatient clinic between 2010 and 2013
Key inclusion criteria (2 listed)
- Clinical diagnosis of stroke
- must be able to receive rehabilitation in an inpatient clinic between 2010 and 2013
Key exclusion criteria (5 listed)
- previous history of stroke,
- other neurological diseases,
- amputation,
- severe arthritis
- undergoing hemodialysis
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 |
|---|---|---|
| Based on the length of hospital stayBased on the length of hospital stay, patients were divided into two groups: hospital stays ≤ 3 months (Group 1) and > 3 months (Group 2).Clinical features and functional output will be then compared between the groups. | Other | Based on the length of hospital stay |
Primary outcome
Clinical features and Functional Independence Measure instrument, the Modified Ashworth Scale, and the Brunnstrom test outcomes will be then compared between the groups.
Time frame: through study completion, an average of 1 month
Demographic features, clinical features and Functional Independence Measure (FIM) instrument, the Modified Ashworth Scale (MAS), and the Brunnstrom test outcomes will be documented for all patients. The FIM includes 18 items with higher scores indicating greater independence. The motor development of the upper extremity, hand, and lower extremity will be evaluated using the Brunnstrom test with higher stages indicating greater development. The degree of spasticity of the upper and lower extremity muscles will be assessed using the MAS with high stage indicating greater spasticity. All patients will be divided into two groups based on length of hospital stay. Clinical features, demographic features and FIM, MAS, and the Brunnstrom test outcomes will be then compared between the groups. All data for normality were tested with Kolmogorov-Smirnov tests. Mann-Whitney U tests will be used for comparison of the differences between the two groups.
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 8 Jan 2021.
- Background: PubMed 3363586Foulkes MA, Wolf PA, Price TR, Mohr JP, Hier DB. The Stroke Data Bank: design, methods, and baseline characteristics. Stroke. 1988 May;19(5):547-54. doi: 10.1161/01.str.19.5.547.
- Background: PubMed 21600267Balaban B, Tok F, Yavuz F, Yasar E, Alaca R. Early rehabilitation outcome in patients with middle cerebral artery stroke. Neurosci Lett. 2011 Jul 12;498(3):204-7. doi: 10.1016/j.neulet.2011.05.009. Epub 2011 May 11.
- Background: PubMed 27079654Hebert D, Lindsay MP, McIntyre A, Kirton A, Rumney PG, Bagg S, Bayley M, Dowlatshahi D, Dukelow S, Garnhum M, Glasser E, Halabi ML, Kang E, MacKay-Lyons M, Martino R, Rochette A, Rowe S, Salbach N, Semenko B, Stack B, Swinton L, Weber V, Mayer M, Verrilli S, DeVeber G, Andersen J, Barlow K, Cassidy C, Dilenge ME, Fehlings D, Hung R, Iruthayarajah J, Lenz L, Majnemer A, Purtzki J, Rafay M, Sonnenberg LK, Townley A, Janzen S, Foley N, Teasell R. Canadian stroke best practice recommendations: Stroke rehabilitation practice guidelines, update 2015. Int J Stroke. 2016 Jun;11(4):459-84. doi: 10.1177/1747493016643553. Epub 2016 Apr 14.
- Individual participant dataSharing planned: No
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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.
betül çiftçi tepeli principal investigator
Kırklareli University School of Health Department of Physical Medicine and Rehabilitiation
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 Stroke, run by Baskent University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 8 Jan 2021. 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 Turkey (Türkiye). 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?
Clinical features and Functional Independence Measure instrument, the Modified Ashworth Scale, and the Brunnstrom test outcomes will be then compared between the groups. (time frame: through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04700982, which also lists 3 linked publications.
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 8 Jan 2021.