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Parkinson DiseaseNCT06827158

Validity and Reliability of the Turkish Version of the Manual Dexterity Questionnaire

An observational study of Parkinson Disease and Validation Studies, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

El fonksiyonunun bozulması, özellikle ince motor becerileri gerektiren aktivitelerde önemli zorluklara yol açar. Parkinson hastalığı teşhisi konan bireylerin yaklaşık %90'ı, gömleği düğmelemek, ayakkabı bağcıklarını bağlamak veya bozuk paralarla uğraşmak gibi elli görevleri yerine getirmekte zorluk çeker. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Parkinson Disease, Validation Studies, Dexterity
What is being tested?
validity and reliability of the Turkish version of the Dexterity Questionnaire 24 (DextQ-24
Type of treatment
Injection or infusion
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Jan 2025to Aug 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Parkinson's disease

Who may be able to join

  • Willingness to participate in the study voluntarily
  • A confirmed diagnosis of Parkinson's disease
  • Age range between 40 and 80 years
  • Disease stage classified as Hoehn \& Yahr Stage I-IV
  • Mini-Mental State Examination (MMSE) score >24

Who cannot join

  • Presence of any neurological disease other than Parkinson's disease (e.g., multiple sclerosis, muscular disorders, stroke)
  • History of any surgical procedure involving the upper extremities
  • Presence of hand deformities unrelated to Parkinson's disease (e.g., rheumatoid arthritis, nerve injury, connective tissue disorders)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site

  • Bandirma Onyedi Eylul University

    Bandırma, Balıkesir, 10200

Other trials in Turkey (Türkiye)

About this study

Official title: Validity and Reliability Study of the Turkish Version of the Manual Dexterity Questionnaire for Parkinson's Patients-24 (DextQ-24)

El fonksiyonunun bozulması, özellikle ince motor becerileri gerektiren aktivitelerde önemli zorluklara yol açar. Parkinson hastalığı teşhisi konan bireylerin yaklaşık %90'ı, gömleği düğmelemek, ayakkabı bağcıklarını bağlamak veya bozuk paralarla uğraşmak gibi elli görevleri yerine getirmekte zorluk çeker. Ambülasyon zorlukları ve bilişsel bozukluğun ardından, el fonksiyonundaki eksiklikler Parkinson hastalığı olan bireylerde yaşam kalitesini olumsuz etkileyen üçüncü en önemli faktörü temsil eder. El Beri Anketi (DextQ-24), Parkinson hastalığı olan bireylerde, özellikle günlük aktiviteler bağlamında el fonksiyonunu değerlendirmek için geçerli ve güvenilir bir araç olarak tanımlanmıştır. Bununla birlikte, mevcut literatürün gözden geçirilmesi ve anketin orijinal geliştiricisi ile doğrudan iletişim, bir Türkçe çevirinin henüz doğrulanmadığını veya güvenilirlik açısından test edilmediğini göstermektedir.

Bu çalışmanın amacı, Parkinson hastalığı olan bireylerde el fonksiyonunun değerlendirilmesi için El Beceri Anketi'nin (DextQ-24) Türkçe versiyonunun geçerliliğini ve güvenilirliğini değerlendirmek, böylece klinik uygulamada, değerlendirmelerde ve gelecekteki araştırmalarda kullanımını kolaylaştırmaktır.

Read the detailed description

Nörolojik hastalıklar sıklıkla el performansını etkileyerek fonksiyonel sakatlıklara yol açar. Bunlar arasında Parkinson hastalığı, el fonksiyonu üzerinde önemli bir etkisi olan hem motor hem de motor olmayan semptomlarla karakterize kronik, ilerleyici bir nörodejeneratif bozukluktur. Hastalık öncelikle substantia nigra'da dopaminerjik nöronların dejenerasyonu veya kaybı ile ilişkilidir ve genellikle orta yaşlı ve yaşlı bireylerde görülür ve başlangıç tipik olarak 50 ila 60 yaşları arasında meydana gelir. Dinlenme titremesi, sertlik, postural instabilite ve bradikinezi gibi motor semptomlar birincil klinik tanı kriterlerini oluşturur. Bradikinezi veya hareket yavaşlığı, yatakta dönme veya oturma pozisyonundan ayakta durma da dahil olmak üzere motor görevleri yerine getirmede zorluklara katkıda bulunur. Ek olarak, nesne manipülasyonunda bozulmalar ve el-parmak koordinasyonunda bir düşüş sıklıkla gözlenmektedir. El fonksiyonunun bozulmasının altında yatan kesin mekanizmalar belirsiz kalsa da, bradikinezi, kas güçsüzlüğü ve azalmış parmak momentumu gibi motor bozuklukların katkıda bulunan faktörler olduğuna inanılmaktadır. El fonksiyonu, Parkinson hastalığının çeşitli aşamalarında günlük ve fonksiyonel aktivitelerin yürütülmesinde çok önemli bir rol oynar.

Assessment and training of hand functions constitute a significant component of treatment approaches in the field of physiotherapy and rehabilitation. Fine and gross motor skills, as well as hand outcome measures, play a crucial role in evaluating hand functions. Various standardized tests, including the Jebsen Taylor Hand Function Test, the Nine-Hole Peg Test, the Purdue Pegboard Test, and the Minnesota Manual Dexterity Test, are commonly used for this purpose. However, assessment tools and questionnaires specifically designed to evaluate hand function in the context of daily living activities remain limited. One such measure is the Hand Skills Questionnaire-36 (HSQ-36), which has been translated into Turkish and validated for reliability. In this study, the validity and reliability of the Turkish version of the Dexterity Questionnaire 24 will be tested using the HSQ-36 and the Nine-Hole Peg Test.

Being tested
validity and reliability of the Turkish version of the Dexterity Questionnaire 24 (DextQ-24
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • validity and reliability of the Turkish version of the Dexterity Questionnaire 24 (DextQ-24Other

    Permission for the Turkish translation and validation of the DextQ-24 questionnaire was obtained from its developer, Tim Vanbellingen. The original English version will be translated into Turkish by two independent translators and then back into English by two native English speakers. After review, the finalized version will be used in the study.

    Patients diagnosed with Parkinson's disease (aged 40-80) will complete consent and demographic forms. The Mini-Mental State Examination (MMSE) will exclude those scoring ≤24. Disease staging will follow the Hoehn and Yahr Scale (stages I-IV included). The MDS-UPDRS (sections II and III) will assess disease severity, while the Nine-Hole Peg Test and Hand Dexterity Scale-36 will evaluate hand function. Participants will complete the Turkish DextQ-24, with 30 randomly selected patients retaking it after two weeks for reliability testing. Data collection per participant will take approximately 30 minutes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dexterity Questionnaire (DextQ-24)

    The questionnaire examines hand functions under five main categories: washing and grooming, dressing, eating and kitchen tasks, daily activities, and TV-CD-DVD usage. Performing a function without difficulty is scored as 1, while being unable to perform the function without external assistance is scored as 4. The total score ranges from 24 to 96. The questionnaire, whose validity and reliability have been investigated in Parkinson's patients, has been shown to be valid and reliable.

    Measured: 5 minutes

  2. Manual Ability Measure (MAM-36)

    MAM-36 is a tool developed to assess hand function in rehabilitation patients. The scale consists of 36 activities and uses a scoring system ranging from 1 to 4, where 1 indicates that the activity cannot be performed, and 4 indicates that it is performed easily (Proud et al., 2019). A Turkish validity and reliability study has been conducted for neurological patients, demonstrating excellent test-retest reliability (ICC: 0.94) and high internal consistency (Cronbach's Alpha: 0.94).

    Measured: 5 minutes

  3. The Nine Hole Peg Test (NHPT)

    The Nine Hole Peg Test (NHPT) involves placing and removing nine pegs and is used to assess fine hand dexterity. The test-retest reliability was found to be ICC: 0.88 for the dominant hand and ICC: 0.91 for the non-dominant hand. It has been identified as a useful assessment tool for evaluating upper extremity function in Parkinson's patients.

    Measured: 2 minute

Secondary outcomes (2)

  1. The Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    MDS-UPDRS, developed in 1980, is widely used in clinical studies and consists of four sections. The first section assesses cognition, behavior, and mood, the second section evaluates activities of daily living, and the fourth section focuses on motor complications, all based on patient and caregiver-reported questionnaires. The third section provides an objective evaluation of the patient's motor abilities. Each item is scored between 0 and 4, with higher scores indicating greater disease severity.

    In 2001, a modified version, the MDS-UPDRS, was introduced. This version consists of 50 items: 13 questions on non-motor experiences (Section 1), 13 questions on motor experiences (Section 2), 18 items assessing motor function (Section 3), and 6 items on motor complications (Section 4). Unlike the original scale, it replaces the term "activities" with "experiences." Scoring remains on a 0 to 4 scale.

    Measured: 20 minutes

  2. Mini-Mental State Examination (MMSE)

    The Mini-Mental State Examination (MMSE) consists of five subcategories: orientation (each question 1 point, total 10 points), immediate recall (3 points), attention and calculation (5 points), recall (3 points), and language (9 points). The total score ranges from 0 to 30. A score of 24 or higher is considered indicative of normal cognitive function. The validity and reliability of the Turkish version of the test have been reported in the literature (r = 0.99)

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2025
  2. Study start10 Jan 2025
  3. Primary completionApr 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

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-control
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06827158
Sponsor's protocol ID
2024-186
Status last verified
Jan 2025
First submitted
10 Feb 2025
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease and Validation Studies, run by Bandırma Onyedi Eylül 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 5 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 21 Feb 2025. 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?

This study is still under way. Results are not available in the source record yet.

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?

Dexterity Questionnaire (DextQ-24) (time frame: 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06827158.

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 21 Feb 2025.

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