ElderlyNCT06083805
Manual Ability Index in Elderly Population
An observational study of Elderly, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly
- How many people
- 220 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 15 Sep 2023
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The sample of the study consists of 220 elderly individuals aged 65 and over residing in the city center of Isparta. The GPower 3.1 program was used to determine the sample size of the study. When the effect size was calculated according to the number of samples taken from a similar study, a rate of 0.24/0.47 was found (8). However, in our study, by choosing the binomial test in the GPower program; after the calculation with an effect size of 0.24 and a power of 95%, it was determined that the sample size should be at least 190 elderly people. In the literature, it is stated that when determining the sample size for factor analysis, an acceptable sample size of 4:1 or 5:1 per item will be sufficient (9).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability and Validity of the Turkish Version of the Manual Ability Index in Elderly Population
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.
Read the detailed 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.
- Conditions
- Elderly
- Keywords
- Elderly, Manual Ability Index, Reliability, Validity, Turkish version
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2023
Secondary outcomes (2)
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.
Measured: 2023
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.
Measured: 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start1 Apr 2023
- Primary completion15 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menekse Safak, Suleyman Demirel University
- Investigators
- Adnan KARAİBRAHİMOĞLU, Assist. Prof., Study director, Suleyman Demirel UniversityMenekşe ŞAFAK, Res. Assist., Principal investigator, Suleyman Demirel UniversityMert USTA, Res. Assist., Principal investigator, Suleyman Demirel UniversityFerdi BAŞKURT, Prof. Dr., Principal investigator, Suleyman Demirel UniversityZeliha BAŞKURT, Prof. Dr., Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083805
- Sponsor's protocol ID
- MS2023/03
- Status last verified
- Oct 2023
- First submitted
- 28 Sep 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of the Manual Ability Index in Elderly Population
- ClinicalTrials.gov ID
- NCT06083805
- Acronym / sponsor ID
- MS2023/03
- Conditions
- Elderly
- Keywords
- Elderly, Manual Ability Index, Reliability, Validity, Turkish version
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 16 Oct 2023 (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.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The sample of the study consists of 220 elderly individuals aged 65 and over residing in the city center of Isparta. The GPower 3.1 program was used to determine the sample size of the study. When the effect size was calculated according to the number of samples taken from a similar study, a rate of 0.24/0.47 was found (8). However, in our study, by choosing the binomial test in the GPower program; after the calculation with an effect size of 0.24 and a power of 95%, it was determined that the sample size should be at least 190 elderly people. In the literature, it is stated that when determining the sample size for factor analysis, an acceptable sample size of 4:1 or 5:1 per item will be sufficient (9).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
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
Manuel Ability Measure
Time frame: 2023
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.
2 secondary outcomes
Duruöz Hand Index
Time frame: 2023
Mini Mental State Test
Time frame: 2023
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 16 Oct 2023.
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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.
Adnan KARAİBRAHİMOĞLU, Assist. Prof. study director
Suleyman Demirel University
Menekşe ŞAFAK, Res. Assist. principal investigator
Suleyman Demirel University
Mert USTA, Res. Assist. principal investigator
Suleyman Demirel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly, run by Suleyman Demirel University at 1 site 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 4 inclusion and 6 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 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Manuel Ability Measure (time frame: 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2023.