About this trial
Diabetes is a chronic metabolic disease that is becoming a growing public health problem worldwide, affecting people's lives in many ways. It is characterized by impaired carbohydrate, lipid, and protein metabolism associated with insufficient insulin secretion and/or reduced sensitivity to the metabolic effects of insulin.Along with diabetes, many complications may develop in affected individuals. Cognitive impairments are now also considered an important and common complication of diabetes.The aim of this study is to investigate the effects of cognitive function levels on functional capacity, balance, fear of falling, and quality of life in individuals with type 2 diabetes.In this context, participants' cognitive function levels will be assessed using the Mini-Mental State Examination and the Stroop Test. Functional capacity will be evaluated using the 6-Minute Walk Test. Balance performance will be assessed using the Biodex Balance System and the Four Square Step Test. Lower extremity muscle strength will be measured using a digital hand-held dynamometer and the 30-Second Sit-to-Stand Test. Fear of falling will be evaluated using the Falls Efficacy Scale-International (FES-I), the Functional Reach Test, and the Timed Up and Go (TUG) Test. Participants' quality of life will be assessed using the WHOQOL-BREF quality of life questionnaire.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being between 40 and 65 years of age
Having an HbA1c level between 6.5 and 11
Having been diagnosed with diabetes for at least 1 year
Scoring 24 or higher on the Mini-Mental State Examination
Disqualifiers
Having a diagnosis of any neurological or psychiatric disorder (e.g., hemiplegia, Alzheimer's disease, Parkinson's disease)
Having uncontrolled hypertension and/or uncontrolled cardiac arrhythmia
Having vertigo or other vestibular system disorders
Having major musculoskeletal disorders
Trial population
The study will be conducted at Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, including the Pulmonary Physiotherapy and Rehabilitation Education and Research Laboratory and the Cardiac Physiotherapy and Rehabilitation Education and Research Laboratory, using face-to-face interview methods with the participants.
Trial design
Other
Cross-sectional
Treatments tested in this trial
No intervention (observational study)
Other interventionThis is an observational study. No treatment was applied to the individuals. The study will evaluate the individuals' cognitive functions and functional capacities, balance, fear of falling, and quality of life.
Treatment groups
Trial outcomes
Primary outcomes
Postural Stability
Postural stability will be assessed using the Biodex Balance System®. This assessment is performed to evaluate the individual's ability to maintain the center of body mass. Deviations from the center of balance will be recorded during the test. Higher stability index scores indicate greater deviation from the center of balance and poorer postural stability.
Limits of Stability
This assessment will be conducted using the Biodex Balance System®. The test will be performed on a static platform. The purpose of the test is to evaluate the individual's ability to shift and control the center of body mass within the base of support. Directional control (overall, forward, backward, left, right, forward/left, forward/right, backward/left, backward/right) will be assessed and expressed as a percentage (%). Higher scores are associated with better postural control.
Sensory Integration of Balance
This assessment will be conducted using the Biodex Balance System®. The purpose of the test is to evaluate how different sensory inputs contribute to the maintenance of balance and how well balance can be preserved when one or more of these sensory inputs are removed. The test will be performed under the following conditions: eyes open and eyes closed on a firm surface, and eyes open and eyes closed on a foam surface. A sway index will be calculated for each condition.
Secondary outcomes
Stroop Test
The Stroop Test is used to assess cognitive function, including processing speed, selective attention, cognitive flexibility, and the ability to inhibit automatic responses.The test consists of three parts, in which participants are required to perform color-word tasks. The completion time of the test will be recorded in seconds.
Mini-Mental State Examination (MMSE)
The Mini-Mental State Examination (MMSE) will be used to assess general cognitive function. The test evaluates the domains of orientation, attention, memory, calculation, and language. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance.
Four Square Step Test
It is used to assess dynamic balance during obstacle negotiation. The patient is instructed to step over four canes placed on the floor in a cross configuration, following a specified sequence. The completion time of the test is recorded in seconds.
Assessment of Functional Capacity
Functional capacity will be assessed using the 6-minute walk test. This test involves participants walking along a 30-meter corridor at their own pace for six minutes, with the distance recorded in meters. At the end of six minutes, the participant is informed that the test is complete and the test is terminated. The expected average walking distance for healthy individuals ranges from 400 to 700 meters.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: