Stroke RehabilitationRSRNCT03927469
Analysis Of The Patients Who Need Rehospitalization Due To Stroke Rehabilitation Only
An observational study of Stroke Rehabilitation, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the clinical and laboratory data of patients who were rehospitalised due to "stroke rehabilitation cause only" The patients who were hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke Rehabilitation
- What is being tested?
- age, sex, hemiplegic side, stroke duration, First hospitalisation duration (day)
- How many people
- 328 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2018to 1 Oct 2018
- 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: The patients who were hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1) were included in the study
Who may be able to join
- Being hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1)
- Being ischemic or hemorrhagic stroke
Who cannot join
- Being hemiplegic due to trauma, cancer and intracranial operation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, 34192
About this study
The aim of this study was to investigate the clinical and laboratory data of patients who were rehospitalised due to "stroke rehabilitation cause only" The patients who were hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1) scanned from the hospital database.
Read the detailed description
All comorbid diseases were included to rehospitalisation rates in stroke patients in the literature. The aim of this study was to investigate the clinical and laboratory data of patients who were rehospitalised due to "stroke rehabilitation cause only" The patients who were hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1) scanned from the hospital database.
There were 554 patients with these diagnoses. 9 patients of them were excluded because of the hemiplegic due to trauma, cancer and intracranial operation. Detailed epicrisis of 545 patients with ischemic or hemorrhagic stroke were examined. 328 patients who did not have missing data were included in the study. Age, sex, hemiplegia etiology, admission season, hemiplegia time, hemiplegic side, 25 (OH) vitamin D and vitamin B12 levels, brunnstrom stage of upper extremity, lower extremity and hand Functional Ambulation Classification (FAC).
Brunnstrom staging was used to identify motor function with 6 levels in the upper extremity and hand. ROM for abduction, flexion, internal rotation, and external rotation were passively measured. Brunnstrom staging was used to evaluate motor development, and stroke patients were defined as 6 stages. The flask phase without the lowest voluntary movement is considered to be stage 1, while the presence of isolated movements is considered to be stage 6. In the Brunstromm staging, upper, lower extremity and hand evaluation are performed separately.
FAC is defined as 5 stages according to the basic motor skills required for functional ambulation. FAC stage 0 is used for non-functional ambulation, stage 5 is used for independent walking at each speed and ground.
- Conditions
- Stroke Rehabilitation
- Being tested
- age, sex, hemiplegic side, stroke duration, First hospitalisation duration (day)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
age, sex, hemiplegic side, stroke duration, First hospitalisation duration (day)Other
Also called Corelation of data, FAC: Functional Ambulation Classification and age, stroke duration, Season, stroke Etiology, Brunnstrom, FAC
This is a retrospiective descriptive study
| Study group | Role | What they receive |
|---|---|---|
| Hospitalisation group | The patients who were hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1) scanned from the hospital database. Receives: Other: age, sex, hemiplegic side, stroke duration, First hospitalisation duration (day) | |
| Re-hospitalisation group. | The patients who were re-hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1) scanned from the hospital database. Receives: Other: age, sex, hemiplegic side, stroke duration, First hospitalisation duration (day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalisation rates
rehospitalisation rates. Data will given as percent
Measured: 3 YEARS
Secondary outcomes (2)
Serum vitamin D level
Serum 25 (OH) vitamin D level. Unit of this parameter is U/L
Measured: 3 YEARS
Serum vitamin B12 level
Serum B12 level. Unit of this parameter is U/L
Measured: 3 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start15 Aug 2018
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke RehabilitationStudies 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
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tuğba Aydın, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- TUGBA AYDIN, Study chair, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927469
- Sponsor's protocol ID
- IstPMRTRH-449
- Acronym
- RSR
- Status last verified
- Apr 2019
- First submitted
- 20 Mar 2019
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ottenbacher KJ, Graham JE, Ottenbacher AJ, Lee J, Al Snih S, Karmarkar A, Reistetter T, Ostir GV. Hospital readmission in persons with stroke following postacute inpatient rehabilitation. J Gerontol A Biol Sci Med Sci. 2012 Aug;67(8):875-81. doi: 10.1093/gerona/glr247. Epub 2012 Mar 2.
PubMed 22389457Sun Y, Lee SH, Heng BH, Chin VS. 5-year survival and rehospitalization due to stroke recurrence among patients with hemorrhagic or ischemic strokes in Singapore. BMC Neurol. 2013 Oct 3;13:133. doi: 10.1186/1471-2377-13-133.
PubMed 24088308
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis Of The Patients Who Need Rehospitalization Due To Stroke Rehabilitation Only
- ClinicalTrials.gov ID
- NCT03927469
- Acronym / sponsor ID
- RSR / IstPMRTRH-449
- Conditions
- Stroke Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 25 Apr 2019 (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 aim of this study was to investigate the clinical and laboratory data of patients who were rehospitalised due to "stroke rehabilitation cause only" The patients who were hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1) scanned from the hospital database.
Detailed description
All comorbid diseases were included to rehospitalisation rates in stroke patients in the literature. The aim of this study was to investigate the clinical and laboratory data of patients who were rehospitalised due to "stroke rehabilitation cause only" The patients who were hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1) scanned from the hospital database.
There were 554 patients with these diagnoses. 9 patients of them were excluded because of the hemiplegic due to trauma, cancer and intracranial operation. Detailed epicrisis of 545 patients with ischemic or hemorrhagic stroke were examined. 328 patients who did not have missing data were included in the study. Age, sex, hemiplegia etiology, admission season, hemiplegia time, hemiplegic side, 25 (OH) vitamin D and vitamin B12 levels, brunnstrom stage of upper extremity, lower extremity and hand Functional Ambulation Classification (FAC).
Brunnstrom staging was used to identify motor function with 6 levels in the upper extremity and hand. ROM for abduction, flexion, internal rotation, and external rotation were passively measured. Brunnstrom staging was used to evaluate motor development, and stroke patients were defined as 6 stages. The flask phase without the lowest voluntary movement is considered to be stage 1, while the presence of isolated movements is considered to be stage 6. In the Brunstromm staging, upper, lower extremity and hand evaluation are performed separately.
FAC is defined as 5 stages according to the basic motor skills required for functional ambulation. FAC stage 0 is used for non-functional ambulation, stage 5 is used for independent walking at each speed and ground.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalisation group | – | Other: age, sex, hemiplegic side, stroke duration, First hospitalisation duration (day)The patients who were hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1) scanned from the hospital database. |
| Re-hospitalisation group. | – | Other: age, sex, hemiplegic side, stroke duration, First hospitalisation duration (day)The patients who were re-hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1) scanned from the hospital database. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who were hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1) were included in the study
Key inclusion criteria (2 listed)
- Being hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1)
- Being ischemic or hemorrhagic stroke
Key exclusion criteria (1 listed)
- Being hemiplegic due to trauma, cancer and intracranial operation
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 |
|---|---|---|
| age, sex, hemiplegic side, stroke duration, First hospitalisation duration (day)Also: Corelation of data, FAC: Functional Ambulation Classification and age, stroke duration, Season, stroke Etiology, Brunnstrom, FACThis is a retrospiective descriptive study | Other | Hospitalisation group, Re-hospitalisation group. |
Primary outcome
Rehospitalisation rates
Time frame: 3 YEARS
rehospitalisation rates. Data will given as percent
2 secondary outcomes
Serum vitamin D level
Time frame: 3 YEARS
Serum vitamin B12 level
Time frame: 3 YEARS
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 25 Apr 2019.
- Background: PubMed 22389457Ottenbacher KJ, Graham JE, Ottenbacher AJ, Lee J, Al Snih S, Karmarkar A, Reistetter T, Ostir GV. Hospital readmission in persons with stroke following postacute inpatient rehabilitation. J Gerontol A Biol Sci Med Sci. 2012 Aug;67(8):875-81. doi: 10.1093/gerona/glr247. Epub 2012 Mar 2.
- Background: PubMed 24088308Sun Y, Lee SH, Heng BH, Chin VS. 5-year survival and rehospitalization due to stroke recurrence among patients with hemorrhagic or ischemic strokes in Singapore. BMC Neurol. 2013 Oct 3;13:133. doi: 10.1186/1471-2377-13-133.
- 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.
TUGBA AYDIN study chair
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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 Rehabilitation, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 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: finished, as of the sponsor's last update on 25 Apr 2019. 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?
Rehospitalisation rates (time frame: 3 YEARS). 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 NCT03927469, which also lists 2 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 25 Apr 2019.