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Reliability and Validity of Hand Function Tests in Carpal Tunnel Syndrome

16. července 2026 aktualizováno: Gülbin Ergin, Izmir Bakircay University

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

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

100

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

The study population will consist of adult patients diagnosed with carpal tunnel syndrome who apply for medical care or undergo clinical evaluation. Participants will be recruited directly from the outpatient clinics of the Department of Orthopedics and Traumatology at a tertiary care university hospital.

Popis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Jebsen-Taylor Hand Function Test
Časové okno: For test-retest reliability: baseline (first measurement) and retest (second measurement, 7 to 14 days after baseline)

A standardized, timed assessment designed to evaluate a broad range of uni-manual hand functions utilizing everyday functional activities. It consists of seven distinct subtests: writing, card turning, picking up small objects, simulated feeding, stacking checkers, picking up large light cans, picking up large heavy cans.

The physiotherapist will demonstrate the test first, followed by a practice trial for the participant. A maximum time limit of 120 seconds is set for each subtest; if a task cannot be completed, the score is recorded as 120 seconds.
For test-retest reliability: baseline (first measurement) and retest (second measurement, 7 to 14 days after baseline)
Minnesota Dexterity Test
Časové okno: For test-retest reliability: baseline (first measurement) and retest (second measurement, 7 to 14 days after baseline)
The Minnesota Dexterity Test is a standardized objective instrument used to evaluate rapid eye-hand coordination and gross arm-hand dexterity. It consists of two primary subtests: the Placing Test and the Turning Test. In the Placing Test, the subject fills the board with 60 cylindrical blocks as quickly as possible. In the Turning Test, the subject turns the blocks over in a specified sequence using both hands alternately. Each subtest will be performed two times. Separate total scores will be calculated for the Placing Test and the Turning Test based on the total time (in seconds) required to complete the trials. Higher scores (longer times) indicate greater impairment and poorer manual dexterity.
For test-retest reliability: baseline (first measurement) and retest (second measurement, 7 to 14 days after baseline)
Nine-Hole Peg Test
Časové okno: For test-retest reliability: baseline (first measurement) and retest (second measurement, 7 to 14 days after baseline)
The Nine-Hole Peg Test is a brief, standardized quantitative assessment used to measure finger dexterity and fine manual velocity. The apparatus consists of a plastic board with nine holes and nine pegs. The participant will be instructed to pick up the pegs one by one from a container, place them into the nine holes as fast as possible, and then remove them one by one, returning them to the container. The test will be performed one time. The score will be recorded as the total time (in seconds) taken to complete the entire task. Higher scores (longer times) indicate worse fine motor dexterity and coordination.
For test-retest reliability: baseline (first measurement) and retest (second measurement, 7 to 14 days after baseline)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Boston Carpal Tunnel Questionnaire
Časové okno: For validity: baseline
The Boston Carpal Tunnel Questionnaire is a patient-reported, disease-specific outcome measure designed to evaluate the severity of symptoms and functional status in patients with carpal tunnel syndrome. It comprises two independent subscales: the Symptom Severity Scale (11 items) and the Functional Status Scale (8 items). Each item is scored on a 5-point Likert scale ranging from 1 (no symptoms/no difficulty) to 5 (most severe symptoms/cannot perform activity). The score for each subscale is calculated as the mean of the completed items, yielding a final score between 1 and 5. Higher scores represent more severe symptoms and worse functional limitation.
For validity: baseline
Michigan Hand Outcomes Questionnaire
Časové okno: For validity: baseline
The Michigan Hand Outcomes Questionnaire is a comprehensive, hand-specific psychometric instrument designed to assess a patient's perception of their hand function and quality of life. It contains 57 items divided into six distinct domains: Overall Hand Function, Activities of Daily Living, Work Performance, Pain, Aesthetics, and Patient Satisfaction. Items are scored on a 5-point scale, and responses are normalized and converted to a standardized score ranging from 0 to 100 for each domain. For the pain domain, a higher score denotes greater pain severity. For the remaining five domains, higher scores represent better hand performance, appearance, and satisfaction.
For validity: baseline
QuickDASH
Časové okno: For validity: baseline
The QuickDASH is a shortened, 11-item version of the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, used to measure physical symptoms and disability in individuals with musculoskeletal disorders of the upper limb. It evaluates symptoms (such as pain and tingling) and the ability to perform specific physical activities during the past week. Each item is rated on a 5-point Likert scale. The scores are summated and transformed to a standardized scale of 0 to 100, where 0 represents no disability and 100 represents the most severe disability and symptom expression.
For validity: baseline
EuroQol 5D-5L
Časové okno: For validity: baseline
The EuroQol 5D-5L is a standardized, generic instrument used to measure health-related quality of life. It consists of two main components: the EQ-5D descriptive system and the EQ Visual Analogue Scale (EQ VAS). The descriptive system covers five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension is rated on 5 levels of severity ranging from 1 (no problems) to 5 (extreme problems). The EQ VAS records the respondent's self-rated health on a vertical visual analogue scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)
For validity: baseline
Hand Grip Strength
Časové okno: For validity: baseline
Hand grip strength will be measured objectively using a calibrated hydraulic hand dynamometer to assess gross hand grip capacity. The testing will be performed with the subject seated comfortably, the shoulder adducted and neutrally rotated, the elbow flexed at 90 degrees, and the forearm and wrist in a neutral position. The assessment will be conducted for the affected hand, with three trials performed for the hand, and a brief rest period allowed between trials. The average score of the three trials is recorded in kilograms. Higher values indicate greater hand grip strength.
For validity: baseline
Pinch Strength
Časové okno: For validity: baseline
The pinch strength will be measured using a calibrated hydraulic pinch gauge. The testing will be performed with the subject seated comfortably, the shoulder adducted and neutrally rotated, the elbow flexed at 90 degrees, and the forearm and wrist in a neutral position. The assessment will be conducted for the affected hand, with three trials performed for the hand, and a brief rest period allowed between trials. The scores will be recorded in kilograms. Higher values represent stronger pinch capacity.
For validity: baseline

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mini-Mental State Examination
Časové okno: Baseline
The Mini-Mental State Examination (MMSE) will be utilized as a brief screening tool to objectively assess the cognitive competence of the participants. The test evaluates global cognitive domains including orientation to time and place, registration, attention and calculation, short-term recall, language, and visuospatial praxis. Total scores range from 0 to 30, with higher scores reflecting better cognitive function. A cut-off score of 24 or above will be required for inclusion to ensure that participants possess the necessary cognitive capacity to fully understand, cooperate with, and accurately execute the multi-step instructions of the physical performance tests.
Baseline

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Izmir Bakircay University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

16. července 2026

Primární dokončení (Odhadovaný)

1. srpna 2027

Dokončení studie (Odhadovaný)

1. září 2027

Termíny zápisu do studia

První předloženo

11. července 2026

První předloženo, které splnilo kritéria kontroly kvality

11. července 2026

První zveřejněno (Aktuální)

15. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

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Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Studuje lékový produkt regulovaný americkým FDA

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Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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