Diabetes MellitusNCT04920279
Validity Of Turkish Version Of ABC Scale In Diabetes Mellitus Patients
An observational study of Diabetes Mellitus and Balance; Distorted, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 2 sites in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Balance; Distorted, Evaluations, Diagnostic Self
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 11 Jun 2018to 28 Feb 2022
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with diabetes mellitus
Who may be able to join
- 45-75 years old
- Diabetes mellitus
- The complete existence of the data to be used in the study in the records of our hospital
Who cannot join
- Not having any other additional disease that will affect balance coordination
- No lower extremity joint replacement or lower extremity amputation at any level
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Istanbul, 34173
IstanbulPMRTRH
Istanbul
About this study
Official title: Validity Of The Turkish Version Of Activities-Specific Balance Confidence Scale In Patients With Diabetes Mellitus
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).
Read the 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.
- Keywords
- balance, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: A single point in time (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start11 Jun 2018
- Primary completion31 Dec 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Feride Sabırlı, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Nurdan Paker, Prof, Principal investigator, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920279
- Sponsor's protocol ID
- IstPMRTRH-FS
- Status last verified
- Feb 2022
- First submitted
- 3 Jun 2021
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
PubMed 7814786Sprint 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.
PubMed 25594979Miller 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. doi: 10.1016/0165-1781(92)90005-n.
PubMed 1594710Paker 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.
PubMed 27858674
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity Of The Turkish Version Of Activities-Specific Balance Confidence Scale In Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04920279
- Acronym / sponsor ID
- IstPMRTRH-FS
- Keywords
- balance, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 9 Jun 2021 (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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with diabetes mellitus
Key inclusion criteria (3 listed)
- 45-75 years old
- Diabetes mellitus
- The complete existence of the data to be used in the study in the records of our hospital
Key exclusion criteria (2 listed)
- Not having any other additional disease that will affect balance coordination
- No lower extremity joint replacement or lower extremity amputation at any level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validity of the Turkish Version of Activities-specific Balance Confidence Scale in Patients With Diagnosis of the Diabetes Mellitus Before.
Time frame: A single point in time (1 day)
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
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 28 Jul 2022.
- Background: PubMed 7814786Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
- Background: PubMed 25594979Sprint 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.
- Background: PubMed 1594710Miller 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. doi: 10.1016/0165-1781(92)90005-n.
- Background: PubMed 27858674Paker 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.
- 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.
Nurdan Paker, Prof principal investigator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Balance; Distorted, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 2 sites 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 3 inclusion and 2 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 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Validity of the Turkish Version of Activities-specific Balance Confidence Scale in Patients With Diagnosis of the Diabetes Mellitus Before. (time frame: A single point in time (1 day)). 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 NCT04920279, which also lists 4 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 28 Jul 2022.