Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment
Stroke Rehabilitation Other: age, sex, hemiplegic side, stroke duration, First hospitalisation duration (day)

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 328 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Analysis Of The Patients Who Need Rehospitalization Due To Stroke Rehabilitation Only
Actual Study Start Date : August 15, 2018
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. Rehospitalisation rates [ Time Frame: 3 YEARS ]
    rehospitalisation rates. Data will given as percent


Secondary Outcome Measures :
  1. Serum vitamin D level [ Time Frame: 3 YEARS ]
    Serum 25 (OH) vitamin D level. Unit of this parameter is U/L

  2. Serum vitamin B12 level [ Time Frame: 3 YEARS ]
    Serum B12 level. Unit of this parameter is U/L



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927469


Locations
Layout table for location information
Turkey
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
İstanbul, Turkey, 34192
Sponsors and Collaborators
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Investigators
Layout table for investigator information
Study Chair: TUGBA AYDIN Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Publications:
Layout table for additonal information
Responsible Party: Tuğba Aydın, Principal Investigator, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03927469    
Other Study ID Numbers: IstPMRTRH-449
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases