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| Name | Class |
|---|---|
| Pamukkale University | OTHER |
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The research is a cross-sectional study and was planned to determine which diabetes mellitus symptoms related to physical competence have a greater impact on balance in patients with diabetes mellitus
The present study was designed as a cross-sectional observational study to investigate the relationship between diabetes mellitus (DM)-related symptoms and physical competence, with a specific focus on balance performance in individuals diagnosed with DM. Considering that diabetes is a chronic metabolic disease that frequently leads to multisystemic complications such as peripheral neuropathy, muscle weakness, sensory impairments, and reduced physical capacity, it is essential to determine how these clinical manifestations affect functional outcomes. Since balance is a critical component of daily living activities and directly influences fall risk, mobility, and quality of life, identifying which DM-related symptoms most strongly contribute to balance impairment may provide important insights for rehabilitation and preventive strategies. By assessing symptom domains related to physical competence and their association with balance performance, this study aims to reveal the key determinants of postural control in patients with DM, thereby guiding both clinical evaluation and individualized intervention programs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | There will be only one group in the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| There will be no intervention in the study. Only descriptive tests will be used. | Diagnostic Test | There will be no intervention in the study. Only descriptive tests will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic balance | Four-Step Square Test (FSST): Two strips were placed perpendicular to each other on the floor to create 4 squares. At the start of the test, the patient stood on square 1 facing square 2. The stepping sequence was as follows: 2-3-4-1-4-3-2-1. Participants were instructed to complete the sequence as fast as possible, without touching the canes or strips, and to ensure that both feet fully contacted the ground in each square. If the participant failed to complete the sequence correctly, lost balance, or touched the cane, the test was repeated. The total time required to complete the test was recorded | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| International Physical Activity Questionnaire-Long Form (IPAQ-LF) | The IPAQ-LF consists of 27 items designed to assess physical activity across various domains, such as of housework, gardening, work activities, transportation, and leisure activities. The weekly physical activity level was calculated as metabolic equivalent of task (MET), by multiplying the activity duration in the previous week. An increase in the score indicates a high level of physical activity. According to the results, participants can be classified as inactive, minimally active, or very active. Inactive (Category 1): The lowest level of physical activity. Situations that do not meet the criteria for Categories 2 or 3 are considered "inactive." Minimally Active (Category 2): Achieving a minimum of 600 MET-min/week, with vigorous activity performed for at least 20 minutes per day on 3 or more days. Very Active (Category 3): At least 3 days of vigorous activity achieving a minimum of 1500 MET-min/week. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Diabetes Mellitus
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| Name | Affiliation | Role |
|---|---|---|
| ÇETİŞLİ KORKMAZ | Pamukkale University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suleyman Demirel University | Isparta | 32200 | Turkey (Türkiye) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2025 | Oct 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009043 | Motor Activity |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 7 months |
| 6-Minute Walking Test (6MWT) | 6-Minute Walking Test (6MWT): The 6MWT is a valid, reliable, and gold standard maximal exercise effort test, that evaluates functional capacity and aerobic efficiency. The 6MWT was performed between two cones placed 30 m apart. Before the test, the physiotherapist recorded the vital signs (blood pressure, heart rate and respiratory rate per minute). The participants were asked to walk as fast as possible for 6 min and were informed in the last 1 min. If the patient had to stop walking within 6 min, they were asked to lean against the wall, but no patient stopped walking. The assessments were repeated at the end of the 6MWT, and the walking distance was recorded in meters. | 7 months |
| Modified Borg Scale (MBS) | Modified Borg Scale (MBS): The MBS is a modified version of the Borg Rating of Perceived Exertion Scale, which was developed to quantify the subjective level of effort experienced during physical activity. The scale is commonly used in clinical rehabilitation to quantify the rates of fatigue-related perceived exertion between 0 and 10. "0" equates to "at rest" and "10" equates to "very, very hard". | 7 months |
| International Urinary Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF) | International Urinary Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF): The ICIQ-UI SF, consisting of 6 items questioning the frequency, amount, and duration of urinary incontinence, and the impact of these complaints on daily life. The ICIQ-UI SF, is a short and simple questionnaire, that is useful in screening incontinence and obtaining brief but comprehensive data on the level, impact, and perceived effects of incontinence symptoms. The highest possible score on the questionnaire is 21. A higher score indicates a greater impact of incontinence. | 7 months |
| D001519 | Behavior |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |