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Идёт набор NCT07706296

Reliability and Validity of Hand Function Tests in Carpal Tunnel Syndrome

— Наблюдательное Carpal Tunnel Syndrome (CTS)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Standardized Hand Function and Dexterity Testing.
Кому может быть актуально
Состояния в реестре: Carpal Tunnel Syndrome (CTS). Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Reliability and Construct Validity of the Jebsen-Taylor Hand Function Test, Minnesota Dexterity Test, and Nine-Hole Peg Test in Patients With Carpal Tunnel Syndrome

Обзор

Carpal tunnel syndrome is a condition that causes numbness, tingling, and weakness in the hand due to pressure on the median nerve in the wrist. This condition often negatively affects a person's hand functions and ability to perform daily activities. While various tests are used in clinics to measure hand function, dexterity, and fine motor skills, there is still a lack of clear consensus in the literature regarding the specific reliability and validity of these particular tests for this patient population. Consequently, it remains uncertain which of these tests are truly accurate, consistent, and most appropriate for routine clinical use in carpal tunnel syndrome. Therefore, it is crucial to scientifically evaluate these tests to fill this gap in the literature. The purpose of this study is to investigate reliability and construct validity of the Jebsen-Taylor Hand Function Test (JTHFT), the Minnesota Dexterity Test (MDT), and the Nine-Hole Peg Test (NHPG) in patients with carpal tunnel syndrome (CTS). To achieve these objectives, a rigorous methodological protocol will be implemented (COSMIN criteria). Test-retest reliability will be evaluated by repeating the assessments within a 7-to-14-day interval. To control for potential learning, fatigue, and adaptation effects, the order of all performance tests will be strictly randomized using a permutation approach during both the initial (baseline) and the second (retest) evaluation sessions. Additionally, measurement error will be calculated using Standard Error of Measurement and Minimal Detectable Change to determine the true clinical precision of these tools. For construct validity, a specific testing sequence and strict randomization strategy will be utilized to minimize response bias. Participants will complete all patient-reported outcome questionnaires prior to undergoing any physical testing. This ensures that a patient's subjective evaluation of their daily life activities is not influenced by their immediate performance or perceived success on the physical tests. Following the questionnaires, hand strength measurements and dexterity performance tests will be administered. The sequence of these physical tests will be fully randomized both among different test modalities and within their internal subtests for each participant. Construct validity will be evaluated through predefined hypothesis testing based on COSMIN guidelines. Convergent validity will be confirmed if a moderate correlation (r≥0.40 or r≤-0.40) is observed between the dexterity tests and structurally related parameters. Divergent validity will be confirmed by a weak correlation (r≥-0.39 and r≤0.39) with structurally unrelated or distinct clinical parameters. Construct validity of the assessments will be considered satisfactory if at least 75% of these predefined hypotheses are confirmed by the statistical analysis.

Подробное описание

Predefined hypothesis (the details of the used questionnaires and measurements are in Outcome Measures):

JTHFT-total score:

* Boston Carpal Tunnel Questionnaire (BCTQ)-Functional Status Scale: Moderate correlation * Michigan Hand Outcomes Questionnaire (MHQ)-Overall hand function: Moderate correlation * MHQ-Activities of daily living: Moderate correlation * MHQ-Work performance: Moderate correlation * QuickDASH (QDASH)-disability/symptom: Moderate correlation * Hand Grip Strength: Moderate correlation * Pinch Strength: Moderate correlation * EuroQol 5D-5L (EQ-5D-5L): Weak correlation * MHQ-Aesthetics: Weak correlation * BCTQ-Functional Status Scale vs. EQ-5D-5L: Correlation with BCTQ-Functional Status Scale is at least 0.1 higher than with EQ-5D-5L * MHQ-Overall hand function vs. EQ-5D-5L: Correlation with MHQ-Overall hand function is at least 0.1 higher than with EQ-5D-5L * MHQ-Activities of daily living vs. EQ-5D-5L: Correlation with MHQ-Activities of daily living is at least 0.1 higher than with EQ-5D-5L * MHQ-Work performance vs. EQ-5D-5L: Correlation with MHQ-Work performance is at least 0.1 higher than with EQ-5D-5L * QDASH-disability/symptom vs. EQ-5D-5L: Correlation with QDASH-disability/symptom is at least 0.1 higher than with EQ-5D-5L * BCTQ-Functional Status Scale vs. BCTQ-Symptom Severity Scale (BCTQ-Symptom): Correlation between BCTQ-Functional Status Scale and BCTQ-Symptom is at least 0.1 higher than between JTHFT-Total and BCTQ-Symptom * MHQ-Overall hand function vs. MHQ-Pain: Correlation between MHQ-Overall hand function and MHQ-Pain is at least 0.1 higher than between JTHFT-Total and MHQ-Pain * MHQ-Overall hand function vs. MHQ-Satisfaction: Correlation between MHQ-Overall hand function and MHQ-Satisfaction is at least 0.1 higher than between JTHFT-Total and MHQ-Satisfaction * MHQ-Activities of daily living vs. MHQ-Pain: Correlation between MHQ-Activities of daily living and MHQ-Pain is at least 0.1 higher than between JTHFT-Total and MHQ-Pain * MHQ-Activities of daily living vs. MHQ-Satisfaction: Correlation between MHQ-Activities of daily living and MHQ-Satisfaction is at least 0.1 higher than between JTHFT-Total and MHQ-Satisfaction * MHQ-Work performance vs. MHQ-Pain: Correlation between MHQ-Work performance and MHQ-Pain is at least 0.1 higher than between JTHFT-Total and MHQ-Pain * MHQ-Work performance vs. MHQ-Satisfaction: Correlation between MHQ-Work performance and MHQ-Satisfaction is at least 0.1 higher than between JTHFT-Total and MHQ-Satisfaction

JTHFT Subtests:

* JTHFT-Writing \& BCTQ-Functional Status Scale Item 1: Moderate correlation * JTHFT-Writing vs. Overall Scales: Correlation with BCTQ-Functional Status Scale Item 1 is at least 0.1 higher than with BCTQ-Total, MHQ-Overall hand function, MHQ-Activities of daily living, MHQ-Work performance, QDASH-disability/symptom, and EQ-5D-5L * JTHFT-Card Turning vs. Overall Scales: Correlation with MHQ-Activities of daily living Item 4 is at least 0.1 higher than with BCTQ-Total, MHQ-Overall hand function, MHQ-Activities of daily living, MHQ-Work performance, QDASH-disability/symptom, and EQ-5D-5L * JTHFT-Small Objects vs. Overall Scales: Correlation with BCTQ-Symptom Severity Scale Item 11 and MHQ-Activities of daily living Item 2 is at least 0.1 higher than with BCTQ-Total, MHQ-Overall hand function, MHQ-Activities of daily living, MHQ-Work performance, QDASH-disability/symptom, and EQ-5D-5L * JTHFT-Simulated Feeding vs. Overall Scales: Correlation with MHQ-Activities of daily living Item C-3 is at least 0.1 higher than with BCTQ-Total, MHQ-Overall hand function, MHQ-Activities of daily living, MHQ-Work performance, QDASH-disability/symptom, and EQ-5D-5L * JTHFT-Stacking Checkers vs. Overall Scales: Correlation with BCTQ-Symptom Item 11 and MHQ-Activities of daily living Item 2 is at least 0.1 higher than with BCTQ-Total, MHQ-Overall hand function, MHQ-Activities of daily living, MHQ-Work performance, QDASH-disability/symptom, and EQ-5D-5L * JTHFT-Light Cans vs. Overall Scales: Correlation with BCTQ-Functional Status Scale Item 4 and MHQ-Activities of daily living Item 3 is at least 0.1 higher than with BCTQ-Total, MHQ-Overall hand function, MHQ-Activities of daily living, MHQ-Work performance, QDASH-disability/symptom, and EQ-5D-5L * JTHFT-Heavy Cans vs. Overall Scales: Correlation with BCTQ-Functional Status Scale Item 4 and MHQ-Activities of daily living Item 3 is at least 0.1 higher than with BCTQ-Total, MHQ-Overall hand function, MHQ-Activities of daily living, MHQ-Work performance, QDASH-disability/symptom, and EQ-5D-5L

Minnesota Dexterity Test (MDT) - Placing \& Turning Scores:

* BCTQ-Functional Status Scale: Moderate correlation * MHQ-Overall hand function: Moderate correlation * MHQ-Activities of daily living: Moderate correlation * MHQ-Work performance: Moderate correlation * QDASH-disability/symptom: Moderate correlation * Hand Grip Strength: Moderate correlation * Pinch Strength: Moderate correlation * EQ-5D-5L: Weak correlation * MHQ-Aesthetics: Weak correlation * BCTQ-Functional Status Scale vs. EQ-5D-5L: Correlation with BCTQ-Functional Status Scale is at least 0.1 higher than with EQ-5D-5L * MHQ-Overall hand function vs. EQ-5D-5L: Correlation with MHQ-Overall hand function is at least 0.1 higher than with EQ-5D-5L * MHQ-Activities of daily living vs. EQ-5D-5L: Correlation with MHQ-Activities of daily living is at least 0.1 higher than with EQ-5D-5L * MHQ-Work performance vs. EQ-5D-5L: Correlation with MHQ-Work performance is at least 0.1 higher than with EQ-5D-5L * QDASH-disability/symptom vs. EQ-5D-5L: Correlation with QDASH-disability/symptom is at least 0.1 higher than with EQ-5D-5L * BCTQ-Functional Status Scale vs. BCTQ-Symptom: Correlation between BCTQ-Functional Status Scale and BCTQ-Symptom is at least 0.1 higher than between MDT (Placing/Turning) and BCTQ-Symptom * MHQ-Overall hand function vs. MHQ-Pain: Correlation between MHQ-Overall hand function and MHQ-Pain is at least 0.1 higher than between MDT (Placing/Turning) and MHQ-Pain * MHQ-Overall hand function vs. MHQ-Satisfaction: Correlation between MHQ-Overall hand function and MHQ-Satisfaction is at least 0.1 higher than between MDT (Placing/Turning) and MHQ-Satisfaction * MHQ-Activities of daily living vs. MHQ-Pain: Correlation between MHQ-Activities of daily living and MHQ-Pain is at least 0.1 higher than between MDT (Placing/Turning) and MHQ-Pain * MHQ-Activities of daily living vs. MHQ-Satisfaction: Correlation between MHQ-Activities of daily living and MHQ-Satisfaction is at least 0.1 higher than between MDT (Placing/Turning) and MHQ-Satisfaction * MHQ-Work performance vs. MHQ-Pain: Correlation between MHQ-Work performance and MHQ-Pain is at least 0.1 higher than between MDT (Placing/Turning) and MHQ-Pain * MHQ-Work performance vs. MHQ-Satisfaction: Correlation between MHQ-Work performance and MHQ-Satisfaction is at least 0.1 higher than between MDT (Placing/Turning) and MHQ-Satisfaction * MDT-Placing vs. Overall Scales: Correlation with BCTQ-Symptom Item 11 is at least 0.1 higher than with BCTQ-Total, MHQ-Overall hand function, MHQ-Activities of daily living, MHQ-Work performance, QDASH-disability/symptom, and EQ-5D-5L. * MDT-Placing vs. Overall Scales: Correlation with MHQ-Activities of daily living Item 2 is at least 0.1 higher than with BCTQ-Total, MHQ-Overall hand function, MHQ-Activities of daily living, MHQ-Work performance, QDASH-disability/symptom, and EQ-5D-5L. * MDT-Turning vs. Overall Scales: Correlation with BCTQ-Symptom Item 11 is at least 0.1 higher than with BCTQ-Total, MHQ-Overall hand function, MHQ-Activities of daily living, MHQ-Work performance, QDASH-disability/symptom, and EQ-5D-5L. * MDT-Turning vs. Overall Scales: Correlation with MHQ-Activities of daily living Item 2 is at least 0.1 higher than with BCTQ-Total, MHQ-Overall hand function, MHQ-Activities of daily living, MHQ-Work performance, QDASH-disability/symptom, and EQ-5D-5L.

Nine-Hole Peg Test (NHPT):

* BCTQ-Functional Status Scale: Moderate correlation * MHQ-Overall hand function: Moderate correlation * MHQ-Activities of daily living: Moderate correlation * MHQ-Work performance: Moderate correlation * QDASH-disability/symptom: Moderate correlation * Hand Grip Strength: Moderate correlation * Pinch Strength: Moderate correlation * EQ-5D-5L: Weak correlation * MHQ-Aesthetics: Weak correlation * BCTQ-Functional Status Scale vs. EQ-5D-5L: Correlation with BCTQ-Functional Status Scale is at least 0.1 higher than with EQ-5D-5L * MHQ-Overall hand function vs. EQ-5D-5L: Correlation with MHQ-Overall hand function is at least 0.1 higher than with EQ-5D-5L * MHQ-Activities of daily living vs. EQ-5D-5L: Correlation with MHQ-Activities of daily living is at least 0.1 higher than with EQ-5D-5L * MHQ-Work performance vs. EQ-5D-5L: Correlation with MHQ-Work performance is at least 0.1 higher than with EQ-5D-5L * QDASH-disability/symptom vs. EQ-5D-5L: Correlation with QDASH-disability/symptom is at least 0.1 higher than with EQ-5D-5L * BCTQ-Functional Status Scale vs. BCTQ-Symptom: Correlation between BCTQ-Functional Status Scale and BCTQ-Symptom is at least 0.1 higher than between NHPT and BCTQ-Symptom * MHQ-Overall hand function vs. MHQ-Pain: Correlation between MHQ-Overall hand function and MHQ-Pain is at least 0.1 higher than between NHPT and MHQ-Pain * MHQ-Overall hand function vs. MHQ-Satisfaction: Correlation between MHQ-Overall hand function and MHQ-Satisfaction is at least 0.1 higher than between NHPT and MHQ-Satisfaction * MHQ-Activities of daily living vs. MHQ-Pain: Correlation between MHQ-Activities of daily living and MHQ-Pain is at least 0.1 higher than between NHPT and MHQ-Pain * MHQ-Activities of daily living vs. MHQ-Satisfaction: Correlation between MHQ-Activities of daily living and MHQ-Satisfaction is at least 0.1 higher than between NHPT and MHQ-Satisfaction * MHQ-Work performance vs. MHQ-Pain: Correlation between MHQ-Work performance and MHQ-Pain is at least 0.1 higher than between NHPT and MHQ-Pain * MHQ-Work performance vs. MHQ-Satisfaction: Correlation between MHQ-Work performance and MHQ-Satisfaction is at least 0.1 higher than between NHPT and MHQ-Satisfaction * NHPT vs. Overall Scales: Correlation with BCTQ-Symptom Item 11 is at least 0.1 higher than with BCTQ-Total, MHQ-Overall hand function, MHQ-Activities of daily living, MHQ-Work performance, QDASH-disability/symptom, and EQ-5D-5L.

Вмешательства

  • Другое Standardized Hand Function and Dexterity Testing
    Participants will not receive any therapeutic, surgical, or pharmacological intervention as part of this observational study. The 'exposure or process of interest' consists solely of undergoing three standardized functional assessments (Jebsen-Taylor Hand Function Test, Minnesota Dexterity Test, and Nine-Hole Peg Test) to evaluate their psychometric properties (reliability and validity) in patients with carpal tunnel syndrome. All testing details are defined in the Outcome Measures section.

Первичные конечные точки

  • Jebsen-Taylor Hand Function Test [Срок оценки: For test-retest reliability: baseline (first measurement) and retest (second measurement, 7 to 14 days after baseline)]
  • Minnesota Dexterity Test [Срок оценки: For test-retest reliability: baseline (first measurement) and retest (second measurement, 7 to 14 days after baseline)]
  • Nine-Hole Peg Test [Срок оценки: For test-retest reliability: baseline (first measurement) and retest (second measurement, 7 to 14 days after baseline)]
Вторичные конечные точки (6)
  • Boston Carpal Tunnel Questionnaire [Срок оценки: For validity: baseline]
  • Michigan Hand Outcomes Questionnaire [Срок оценки: For validity: baseline]
  • QuickDASH [Срок оценки: For validity: baseline]
  • EuroQol 5D-5L [Срок оценки: For validity: baseline]
  • Hand Grip Strength [Срок оценки: For validity: baseline]
  • Pinch Strength [Срок оценки: For validity: baseline]

Критерии участия

Критерии включения

  • Diagnosed with unilateral carpal tunnel syndrome by an orthopedist based on electromyography (EMG) evaluation and clinical examination
  • Being literate (ability to read and write)
  • Having a Mini-Mental State Examination (MMSE) score of 24 or above, administered for the assessment of cognitive competence

Критерии исключения

  • Individuals who have previously undergone any surgical intervention on the upper extremity
  • Individuals with symptomatic pathologies in the cervical region (e.g., cervical disc herniation)
  • Having a history of neurological disease
  • Individuals diagnosed with rheumatic diseases affecting the upper extremity (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.)
  • Individuals with current pain complaints in the upper extremity due to any reason (other than carpal tunnel syndrome)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Turkey (Türkiye) · 1 центр
  • İzmir Bakırçay University — Izmir

Идентификаторы

NCT: NCT07706296 · 2776

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗