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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04920279
Other study ID # IstPMRTRH-FS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 11, 2018
Est. completion date February 28, 2022

Study information

Verified date February 2022
Source Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 28, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 45 Years to 75 Years
Eligibility 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

Study Design


Locations

Country Name City State
Turkey Istanbul Physical Medicine Rehabilitation Training & Research Hospital Istanbul
Turkey IstanbulPMRTRH Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Miller MD, Paradis CF, Houck PR, Mazumdar S, Stack JA, Rifai AH, Mulsant B, Reynolds CF 3rd. Rating chronic medical illness burden in geropsychiatric practice and research: application of the Cumulative Illness Rating Scale. Psychiatry Res. 1992 Mar;41(3):237-48. — View Citation

Paker N, Bugdayci D, Demircioglu UB, Sabirli F, Ozel S. Reliability and validity of the Turkish version of Activities-specific Balance Confidence scale in symptomatic knee osteoarthritis. J Back Musculoskelet Rehabil. 2017;30(3):461-466. doi: 10.3233/BMR-150335. — View Citation

Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. — View Citation

Sprint G, Cook DJ, Weeks DL. Toward Automating Clinical Assessments: A Survey of the Timed Up and Go. IEEE Rev Biomed Eng. 2015;8:64-77. doi: 10.1109/RBME.2015.2390646. Epub 2015 Jan 12. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Validity of the Turkish Version of Activities-specific Balance Confidence Scale in Patients With Diagnosis of the Diabetes Mellitus Before. The Activities-specific Balance Confidence Scale (ABC Scale) is a structured questionnaire that measures an individual's confidence in performing activities without losing balance. Total score ranges from 0% to 100%. Lower than 50 %: low level; 50-80 %: moderate level above 80 %: high level of physical functioning A single point in time (1 day)
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