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Validity Of Turkish Version Of ABC Scale In Diabetes Mellitus Patients

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ClinicalTrials.gov Identifier: NCT04920279
Recruitment Status : Recruiting
First Posted : June 9, 2021
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Feride Sabırlı, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Tracking Information
First Submitted Date June 3, 2021
First Posted Date June 9, 2021
Last Update Posted Date June 9, 2021
Actual Study Start Date June 11, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2021)
Validity of the Turkish Version of Activities-specific Balance Confidence Scale in Patients With Diagnosis of the Diabetes Mellitus Before. [ Time Frame: In 2021 ]
cross-sectional
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validity Of Turkish Version Of ABC Scale In Diabetes Mellitus Patients
Official Title Validity Of The Turkish Version Of Activities-Specific Balance Confidence Scale In Patients With Diabetes Mellitus
Brief Summary Activities-specific Balance Confidence (ABC) scale is a well-known tool to evaluate functional balance. Diabetic patients suffer more often from balance disorders than the rest of the population. The aim is to investigate the validity of the Turkish version of ABC short form in patients with diabetes mellitus (DM).
Detailed Description

Thirty patients with DM will be included according to the inclusion and exclusion criteria. All the participants will be evaluated by ABC form and Timed Up and Go Test (TUG). The Cumulative Illness Rating Scale (CIRS ) will be used for all the patients.

ABC scale is a self-assessment test with 16 items that helps assess balance impairments and falling risk, and it also investigates how confident people are while they are in some specific activities both indoors, and outdoors. Total score changes between 0-100.

The HbA1c values of all patients will be noted if a blood test will be performed in the last three months.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient with diabetes mellitus
Condition
  • Diabetes Mellitus
  • Balance; Distorted
  • Evaluations, Diagnostic Self
Intervention Not Provided
Study Groups/Cohorts The patients with diabetes mellitus
When patients with diabetes mellitus admitted to our outpatient clinic if they have inclusion criteria, we have used the ABC questionnaire. And we have done perform Time Up And Go Test twice respectively.
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 Recruiting
Estimated Enrollment
 (submitted: June 3, 2021)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 30, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 45-75 years old
  • Diabetes mellitus
  • The complete existence of the data to be used in the study in the records of our hospital

Exclusion Criteria:

  • Not having any other additional disease that will affect balance coordination
  • No lower extremity joint replacement or lower extremity amputation at any level
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Feride Sabirli, MD 05427232153 fsabirli@gmail.com
Contact: Nurdan Paker, Prof 05326917591 nurdanpaker@hotmail.com
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04920279
Other Study ID Numbers IstPMRTRH-FS
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 Feride Sabırlı, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study Sponsor Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Nurdan Paker, Prof Istanbul Physical Medicine Rehabilitation Training and Research Hospital
PRS Account Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Verification Date June 2021