NCT06083805

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

September 28, 2023

Last Update Submit

October 11, 2023

Conditions

Keywords

ElderlyManual Ability IndexReliabilityValidityTurkish version

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Duruöz Hand Index

    2023

  • Mini Mental State Test

    2023

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menekşe ŞAFAK

Isparta, Merkez, 32000, Turkey (Türkiye)

Location

Study Officials

  • Adnan KARAİBRAHİMOĞLU, Assist. Prof.

    Suleyman Demirel University

    STUDY DIRECTOR
  • Menekşe ŞAFAK, Res. Assist.

    Suleyman Demirel University

    PRINCIPAL INVESTIGATOR
  • Mert USTA, Res. Assist.

    Suleyman Demirel University

    PRINCIPAL INVESTIGATOR
  • Ferdi BAŞKURT, Prof. Dr.

    Suleyman Demirel University

    PRINCIPAL INVESTIGATOR
  • Zeliha BAŞKURT, Prof. Dr.

    Suleyman Demirel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Res. Assist.

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 16, 2023

Study Start

April 1, 2023

Primary Completion

August 15, 2023

Study Completion

September 15, 2023

Last Updated

October 16, 2023

Record last verified: 2023-10

Locations