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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Jebsen-Taylor Hand Function Test
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Jebsen-Taylor Hand Function Test
时间窗: 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.
Minnesota Dexterity Test
时间窗: 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.
Nine-Hole Peg Test
时间窗: 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.
次要结局
- 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)
- Pinch Strength(For validity: baseline)
研究者
Gülbin Ergin
Prof.
Izmir Bakircay University