Validity And Reliability of the Turkish Version of the Thumb Disability Examination

April 26, 2021 updated by: Feray Karademir, Hacettepe University
Purpose of the study is the validity and reliability of the Turkish version of The Thumb Disability Examination (TDX) so that it would be used as an assessment tool for Turkish thumb patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The hand can be used as a very useful instrument that can perform very complex manipulations that require force and precision. In addition, it is specialized for touch and feeling, and it has a great role in perceiving the environment. The most important part that adds functionality to the hand is the thumb. It contributes more than other fingers during thumb grip activities. However, due to many factors such as inflammatory and neurological causes, orthopedic problems such as tendon and ligament injuries, the thumb joints may be loaded above normal. Mechanical stresses over time cause thumb pain and functional disabilities in daily life activities. Symptoms, muscle strength, normal joint movements, and functional conditions of the patients are objectively evaluated in the clinic by various methods. Patient-based questionnaires, such as The Disabilities of the Arm, Shoulder and Hand (DASH) and Michigan Hand Outcome Questionnaire, can evaluate the independence levels and performances of the patients in daily living activities. However, these questionnaires are used in all upper extremity pathologies, and there is no Turkish scale that evaluates only the function of the thumb, pain and patient satisfaction. During the clinical evaluations of patients with thumb complaints, a scale with a higher sensitivity than the DASH questionnaire, with a validity and reliability study that informs us of their performance and pain from the patients' perspective, is needed. Therefore The Thumb Disability Examination (TDX) was created by selecting the items that are suitable for the thumb from the DASH and Michigan Hand Outcome (MHQ) questionnaires. In this study, cultural adaptation of TDX to Turkish cultural will be done. In this process, the questionnaires will be translated from English to Turkish by two different people. A single Turkish translation will be created from these translations. This Turkish survey will be translated into English by two native speakers of English but who speak Turkish very well, and the English questionnaire will be compared with the original survey. In our study, the Turkish version and reliability (internal consistency, test and retest reliability) of the TDX will be evaluated. Voluntary patients who have been diagnosed in the study and applied to Hacettepe University, Faculty of Physiotherapy and Rehabilitation, Hand Surgery Rehabilitation Unit within the last 6 months will be included. Detailed information about the study to be carried out will be given to the patients face to face and if they accept, the informed consent form will be signed. DASH, SF-36, TDX, Beck Depression and Beck Anxiety, Michigan Hand Outcome Questionnaires, pain, normal joint motion, grip strength assessments will be done to patients twice, 3 days apart.The data obtained as a result of the study will help to identify the problems in patients with thumb pain and to show the effectiveness of the treatments from the patient's perspective. We considered that adding the Turkish adaptation of this questionnaire to the literature by making validity and reliability studies will contribute to clinical evaluations. The data obtained as a result of the study will help to identify the problems in patients with thumb complaints and to show the effectiveness of the treatments from the patient's perspective.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ankara
      • Altındag, Ankara, Turkey, 06100
        • Hacettepe University Physiotherapy and Rehabilitation Faculty, Hand Surgery Rehabilitation Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Voluntary patients who applied to Hacettepe University, Faculty of Physiotherapy and Rehabilitation, Hand Surgery and Rehabilitation Unit within the last 6 months, with a history of TMC OA, De Quervain, trigger finger, fracture involving the thumb bones, ligament and tendon injuries, will be included in the study.

Description

Inclusion Criteria:

  • able to speak, read, understand and write in Turkish
  • having thumb pain
  • being over the age of 18

Exclusion Criteria:

  • mental disorders
  • cognitive limitations
  • able not to speak, read, understand and write in Turkish
  • out of age 18-80 years old.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patient
patients with thumb pain or functional problems
Other: Thumb Disability Examination
Turkish Version of Thumb Disability Examination. The Turkish Version of Thumb Disability Examination consists of 20 questions related with thumb pain and functionality.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Thumb Disability Examination (TDX)
Time Frame: Baseline- 3 days later
TDX is a 20-question survey divided into 3 sections. It can be calculated as a whole or for each section alone. All scoring is done on a 0-100 scale, with 0 being the least and 100 the most disability.
Baseline- 3 days later
Visüel Analog Scale- Pain
Time Frame: Baseline
The severity of the pain felt by individuals during the activity that they have difficulty will be evaluated using the Visual Analogue Scale (VAS).
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame: Baseline- 3 days later
DASH contains 30 items related to symptoms and activities of daily living. The total score is 100 and higher scores indicate more disability.
Baseline- 3 days later

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Michigan Hand Outcomes Questionnaire
Time Frame: Baseline
It consists of 6 subtitles: general hand function, ADL (unilateral and bilateral), work, pain, aesthetics and satisfaction. Subheadings are filled separately for the right and left hand. The score for each title is calculated separately. The percentage of raw scores obtained by summing the scores given to each question is calculated and normalized. High scores indicate better functional level.
Baseline
Short Form-36
Time Frame: Baseline
Includes 36 questions in eight sub-scales: physical function, physical role restriction, emotional role restriction, body pain, social function, mental health, vitality, and general health. The score of each sub-dimension ranges from 0 to 100. The score is directly proportional to the quality of life.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO 18/205

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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