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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06083805
Other study ID # MS2023/03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date September 15, 2023

Study information

Verified date October 2023
Source Suleyman Demirel University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to conduct a Turkish validity and reliability study of the hand ability scale in the elderly population. Thus, the psychometric properties of the scale, which evaluates hand use in daily life activities in detail and functionally, will be determined in the elderly and an alternative method will be created to evaluate hand functions in the elderly.The sample of the study consists of 220 elderly individuals aged 65 and over residing in the city center of Isparta. Two independent native Turkish translators performed forward translation. To ensure clinical consistency, it was sent to an expert committee of seven expert physiotherapists, 2 neurologists, 1 gerontologist, and 2 translators with no medical or clinical background to reveal vague concepts in the original questionnaire. A single consequent Turkish translation was formed from the combination of the two translations The Turkish scale was translated back into English by two English-native speakers who speak Turkish fluently, and the English version of the scale was compared to the original. A group of experts authorized the final version of the document in Turkish, which was back ward translation. Translators reviewed the translations and compared certain inconsistencies.


Description:

Aging is a complex multifactorial process, the basic mechanism of which is not fully elucidated and leads to deterioration of biological functions.It is stated that the loss of hand function seen in the elderly leads to poor performance in activities of daily living and recreational activities. For this reason, performance measurements in the elderly should include hand function measurement and aim to measure the adequacy and participation of the functions that the elderly person frequently uses in daily life activities. Scales applied to evaluate hand function are generally performance-based. The hand ability scale is among the scales that evaluate hand functions. The scale is used in the subjective evaluation of upper extremity functions and many parameters related to daily living activities in neurological and musculoskeletal problems.Healthy volunteers over the age of 65 were reached from various centers in Isparta, especially the applications made through the announcements on the bulletin boards on the Süleyman Demirel University campus. Each participant was informed about the content of the study, and the volunteers read and signed informed consent forms. Before the formal questionnaire, the pre-final Turkish version of the questionnaire was used for a pilot test. The Turkish translation was primarily applied to five participants for the detection of unintelligible questions or words. Turkish translation was applied to five participants in order to determine the questions or words that were not understood. Investigators asked the participants the following questions: "Is there a question you don't understand?" "Are there any words you don't like?" Since the participants did not have any problems, no changes were made in the questionnaire and the final Turkish version of the MAM (MAM-T) was provided.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date September 15, 2023
Est. primary completion date August 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Being 65 years or older, - Being literate, - Volunteering to participate in the research, - It means getting a score of 24 or above when the Standardized Mini Mental Test Score is applied. Exclusion Criteria: - Having a condition that prevents them from performing daily life activities, - Having serious vision and hearing loss, - Having any neurological, orthopedic or rheumatological comorbidities that may affect hand functions, such as diagnosed stroke, carpal tunnel, lateral epicondylitis, - Having a diagnosed psychiatric disorder, - Lack of cooperation, - Being in the recovery period of an acute illness.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Menekse SAFAK Isparta Merkez

Sponsors (1)

Lead Sponsor Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Manuel Ability Measure The Manual Ability Measure-36 (MAM-36) is a 36-item scale that assesses perceived ease or difficulty in performing daily activities (e.g., eating, dressing, buttoning clothes) using one's hands, regardless of which hand is used and excluding the use of assistive equipment. It is scored between 0 and 4 points according to the Likert scale. 2023
Secondary Duruöz Hand Index The Duruöz Hand Index (DHI) was first developed in 1996 for the assessment of hand functions in patients with rheumatoid arthritis; It is a valuable test with proven validity and reliability in many diseases related to the upper extremity. The test consists of 18 questions and is presented by separating daily life functions, does not require additional training and equipment for the test, and is a simple, useful and reliable test that takes approximately 3-5 minutes to apply. Answers are given on a Likert scale, and a lower score indicates better functional status. 2023
Secondary Mini Mental State Test Mini Mental State Test (MMDT) will be used to evaluate the cognitive functions of individuals. The test, which is gathered under 6 main headings as orientation, recording memory, attention and calculation, recall and language, is evaluated over a total of 30 points. A value of 24 is accepted as the threshold value, and a decrease in this value indicates deterioration in cognitive functions. The validity and reliability study of the test was performed by Güngen et al. 2023
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