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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06444061
Other study ID # ADagbasi003
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 10, 2024
Est. completion date February 10, 2025

Study information

Verified date June 2024
Source Necmettin Erbakan University
Contact abdulkadir dagbasi
Phone 5414933347
Email kadirdagbasi@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Falls in older adults lead to serious consequences, including injury, associated comorbidities, and death. It also causes long-term immobilization and related complications. Therefore, studies on fall issues such as screening for fall risk factors in older adults, measures to be taken to prevent falls, and limiting the effects of falls can contribute to public health by reducing falls in older adults and limiting their effects. In this context, research on the evaluation and development of balance has an extremely important place. So far, physical performance tests and scales have been developed that evaluate different aspects of balance. One of these scales is the Balance Restoration Self-Confidence Scale (BRC). However, the Turkish adaptation of BRC has not been made yet. For these reasons, the aim of the study is to investigate the validity and reliability of the Turkish version of the BRC in community-dwelling older adults.


Description:

Old age is a period when individuals lose their independence, the risk of accidents increases and their physical abilities decrease. With aging, changes occur in a person's anatomy and physiology; histological differentiation occurs in tissues and cells, while organ functions decrease. With aging, cardiac output decreases, blood pressure increases, and atherosclerosis develops; Gas exchange of the lungs is impaired, vital capacity decreases; There are losses in the functioning of the gastrointestinal tract, atrophic gastritis and impaired drug metabolism in the liver are common in the elderly; blood sugar rises and osteoporosis occurs with a decrease in bone mass; Muscles atrophy and lean muscle mass decreases. All these morphological and physiological changes bring about immobilization, incontinence, depression, delirium, dementia, pressure sores, osteoporosis, fragility and falls. Falls threaten the lives of older adults, increase their dependency, and impair their quality of life. According to the World Health Organization, falls are the second leading cause of unintentional injury deaths in the elderly. At the same time, one in five falls results in serious injuries such as bone fractures and head trauma. Environmental risk factors for falls in older adults include slippery surfaces, poor weather, inadequate lighting, unfamiliar stairs and flooring, cables in the ground, etc. the availability of items to hang on, and the lack of handles in bathrooms and toilets. Biological risk factors are advanced age, being female, chronic or acute disease, muscle weakness, osteoporosis, immobility, visual impairment, decreased postural control, gait disorder, decreased reaction time, loss of balance, coordination disorder and cognitive disorders. Whatever the cause, loss of balance control is the primary cause of falls in older adults. For this reason, evaluation and improvement of balance control in the elderly has become one of the main areas of study in the literature on this subject. The complex structure of balance control also makes its evaluation difficult. Balance control; It requires postural control and control of the center of mass. Postural control is the alignment of the head and body within the support surface against gravity. Interpretation of the environment through visual feedback forms the basis of maintaining postural control. There are many clinical tests to evaluate postural control, such as the functional reaching test, which is based on evaluating static and dynamic balance. Control of the center of mass is the restoration of the center of mass to its previous position after internal or external forces change the center of mass. Control of the center of mass requires the coordination of some movement strategies. Adaptation to the change of the center of mass can also be evaluated with tests such as the Reactive Balance test and Retropulsion test. However, it is thought to be effective in balance control, balance self-efficacy and psychological concerns. For this reason, patient-reported scales measuring self-efficacy and psychological concerns have been developed to evaluate self-efficacy and psychological concerns regarding balance control. Patient-reported scales measuring self-efficacy and psychological concerns regarding balance control mainly focus on fear of falling, impact of falling, and balance confidence (self-confidence in maintaining balance). Fear of falling can be defined as the fear of walking or standing as a result of previous falls. Scales such as the Activity and Fear of Falling Questionnaire in the Elderly and the Falls Efficacy Scale International (FES-I) are scales developed to evaluate the fear of falling. Fall impact refers to self-confidence in performing daily living activities without falling. Some scales, such as the Fall Effectiveness Scale and the Fall Risk Management and Prevention Ability Perception Scale, were developed to measure the impact of falls. Balance confidence is an individual's self-efficacy to maintain balance while performing a goal-directed task or participating in a specific activity. Scales such as the activities-specific balance confidence (ABC) scale and CONFbal scale are scales structured to measure balance confidence. However, apart from these three important areas of self-efficacy and anxiety (fear of falling, impact of falling and balance confidence), another area that is thought to be important in preventing falls and mitigating their consequences is self-confidence in correcting balance. Confidence in restoring balance; It is the self-sufficiency in restoring the balance that is disrupted as a result of the change of the center of mass by internal or external forces. In other words, self-confidence in restoring balance is the perception of success in stopping a fall at any stage after the fall begins. Self-confidence in restoring balance has been measured in the literature with scales that measure fall efficiency, such as the FES-I or the ABC Scale. However, none of the mentioned scales were developed to measure this area and will not fully reflect the perception of self-confidence in restoring balance. For this reason, BRC was developed by Soh et al. in 2022 to specifically measure the perception of self-confidence in restoring balance. Although the use of the scale has become increasingly widespread in the world by adapting it to different languages, the scale has not yet been adapted to the Turkish language. Therefore, the aim of the current study is to adapt BRC to Turkish in community-dwelling older adults.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 76
Est. completion date February 10, 2025
Est. primary completion date June 21, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Being 65 years or older - Being literate in Turkish - Having at least one near fall or a history of falling in the last 12 months - Living independently in the community, with or without the use of a walking aid - Not having enough cognitive dysfunction to score 24 or less on the SMM test - Being able to walk 6 meters in 12 seconds in the ZKYT test - Having the hand reaction to grasp a 30 cm ruler with both hands Exclusion Criteria: - Walking around the house with the physical assistance of another person. - Known active malignant conditions - Cardiovascular conditions such as neural syncope, cardiac syncope, structural heart diseases such as aortic stenosis, or hospitalization due to myocardial infarction or heart surgery within the last three months - Lung disorders such as chronic severe obstructive pulmonary disease or oxygen dependence, - Musculoskeletal disorders such as moderate to severe osteoarthritis, which can affect balance control and muscle function; for example, self-reported trunk and extremity pain or dysfunction, fractures or injuries to the extremities in the past six months - Neurological conditions such as Parkinson's Disease, sequelae of stroke, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, severe Dementia or epilepsy - Legal blindness, severe visual impairment, severe hearing impairment or legal deafness

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Necmettin Erbakan University

References & Publications (1)

Soh SL, Tan CW, Xu T, Yeh TT, Bte Abdul Rahman F, Soon B, Gleeson N, Lane J. The Balance Recovery Confidence (BRC) Scale. Physiother Theory Pract. 2024 Mar 3;40(3):658-669. doi: 10.1080/09593985.2022.2135420. Epub 2022 Oct 19. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The balance recovery confidence (BRC) scale The scale consists of 19 items. The scale measures the self-confidence ability to correct balance in different situations that may cause loss of balance, such as stumbling or slipping. Items are scored between 0 and 10, and the maximum score is 190. A high score indicates a high perception of self-confidence in correcting balance (16). first measurement, repeat measurement (7 days)
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