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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05838820
Other study ID # 012/005988
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 18, 2023
Est. completion date October 1, 2023

Study information

Verified date April 2023
Source Ahram Canadian University
Contact Mohamed M ElMeligie, Ph.d
Phone +201064442032
Email mohamed.elmeligie@acu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a cross-sectional study that aims to establish the test-retest reliability of two standardized tests (Jebsen-Taylor Hand Function Test and Nine-Hole Peg Test) in individuals with carpal tunnel syndrome (CTS). The study will involve at least 50 participants with CTS who will complete the tests twice, with a 1-week interval between the two assessments. The test-retest reliability will be assessed using intraclass correlation coefficient (ICC) and Bland-Altman plots. The study is expected to provide information on the reliability of these tests in individuals with CTS, which can help clinicians more accurately assess hand function and monitor treatment outcomes.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date October 1, 2023
Est. primary completion date September 27, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Individuals diagnosed with carpal tunnel syndrome (CTS) - 18 years of age to 60 years old - Able to provide informed consent to participate in the study Exclusion Criteria: - History of hand or wrist surgery within the past 6 months - Severe hand or wrist pain that would prevent completion of the tests - Severe cognitive impairment or language barrier that would prevent understanding of the test instructions - Any other medical condition that could affect hand function or interfere with test completion - Participation in any other clinical trial or research study involving the hand or wrist within the past 3 months - Inability to comply with study procedures or follow-up requirements

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Nine-Hole Peg Test
The Nine-Hole Peg Test is a standardized test that measures manual dexterity and finger movement speed in individuals with hand impairments. The test involves the placement of nine pegs in a pegboard, one at a time, and then removal of each peg as quickly as possible using one hand. The test is timed, and the time required to complete the test provides an indication of manual dexterity and finger movement speed. The Nine-Hole Peg Test has been previously validated and is commonly used in clinical practice.
Jebsen-Taylor Hand Function Test
is a standardized test that assesses fine motor skills and functional abilities of the hand. The test involves the completion of seven subtests, including writing, simulated page turning, picking up small objects, stacking checkers, lifting large objects, simulated feeding, and stacking cans. Each subtest is timed, and the time required to complete each subtest provides an indication of hand function. The Jebsen-Taylor Hand Function Test has been previously validated and is commonly used in clinical practice.

Locations

Country Name City State
Egypt Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al ?ayy Ath Thamin Giza

Sponsors (1)

Lead Sponsor Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Test-Retest Reliability of Jebsen-Taylor Hand Function Test and Nine-Hole Peg Test in Individuals with Carpal Tunnel Syndrome The primary outcome measure of this study is the test-retest reliability of the Jebsen-Taylor Hand Function Test and the Nine-Hole Peg Test in individuals with carpal tunnel syndrome (CTS). Test-retest reliability will be assessed using the intraclass correlation coefficient (ICC) and Bland-Altman plots. 1-week interval between the two assessments
Secondary Correlation with clinical measures This secondary outcome measure assesses the inter-rater reliability of the Jebsen-Taylor Hand Function Test and the Nine-Hole Peg Test in individuals with carpal tunnel syndrome (CTS). This will involve comparing the results of the tests administered by two different raters to determine the consistency of the results. 1-week interval between the two assessments
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