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Analysis Of The Patients Who Need Rehospitalization Due To Stroke Rehabilitation Only (RSR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927469
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Tuğba Aydın, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Tracking Information
First Submitted Date March 20, 2019
First Posted Date April 25, 2019
Last Update Posted Date April 25, 2019
Actual Study Start Date August 15, 2018
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 24, 2019)
Rehospitalisation rates [ Time Frame: 3 YEARS ]
rehospitalisation rates. Data will given as percent
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 24, 2019)
  • Serum vitamin D level [ Time Frame: 3 YEARS ]
    Serum 25 (OH) vitamin D level. Unit of this parameter is U/L
  • Serum vitamin B12 level [ Time Frame: 3 YEARS ]
    Serum B12 level. Unit of this parameter is U/L
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Analysis Of The Patients Who Need Rehospitalization Due To Stroke Rehabilitation Only
Official Title Analysis Of The Patients Who Need Rehospitalization Due To Stroke Rehabilitation Only
Brief 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), 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 Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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
Condition Stroke Rehabilitation
Intervention Other: age, sex, hemiplegic side, stroke duration, First hospitalisation duration (day)
This is a retrospiective descriptive study
Other Name: Corelation of data, FAC: Functional Ambulation Classification and age, stroke duration, Season, stroke Etiology, Brunnstrom, FAC
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Other: age, sex, hemiplegic side, stroke duration, First hospitalisation duration (day)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 24, 2019)
328
Original Actual Enrollment Same as current
Actual Study Completion Date October 1, 2018
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Being hemiplegic due to trauma, cancer and intracranial operation
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03927469
Other Study ID Numbers IstPMRTRH-449
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Tuğba Aydın, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study Sponsor Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Collaborators Not Provided
Investigators
Study Chair: TUGBA AYDIN Istanbul Physical Medicine Rehabilitation Training and Research Hospital
PRS Account Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Verification Date April 2019