NCT06827158

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

January 10, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

February 21, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

February 10, 2025

Last Update Submit

February 20, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    5 minutes

  • 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).

    5 minutes

  • 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.

    2 minute

Secondary Outcomes (2)

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

    20 minutes

  • Mini-Mental State Examination (MMSE)

    10 minutes

Interventions

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.

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Parkinson's disease

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandirma Onyedi Eylul University

Bandırma, Balıkesir, 10200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Gulhan Yilmaz Gokmen, Assos. Prof.

    Bandırma Onyedi Eylül University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assos. Prof.

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 14, 2025

Study Start

January 10, 2025

Primary Completion

April 1, 2025

Study Completion

August 1, 2025

Last Updated

February 21, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations