Reliability and Validity of Hand Function Tests in Carpal Tunnel Syndrome

NCT07706296 | Recruiting

• 1 other identifier: 2776
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome (CTS)

Outcome Measures

Primary Outcomes (3)

• Jebsen-Taylor Hand Function Test

  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

  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

  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)

Secondary Outcomes (6)

• Boston Carpal Tunnel Questionnaire

  For validity: baseline

• Michigan Hand Outcomes Questionnaire

  For validity: baseline

• QuickDASH

  For validity: baseline

• EuroQol 5D-5L

  For validity: baseline

• Hand Grip Strength

  For validity: baseline

Other Outcomes (1)

• Mini-Mental State Examination

  Baseline

Interventions

Standardized Hand Function and Dexterity Testing OTHER

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

İzmir Bakırçay University

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Central Study Contacts

Gülbin Ergin, PhD

CONTACT

+902324930000; gulbin.ergin@bakircay.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 15, 2026
• Study Start: July 16, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)