Hand Function Tests in Carpal Tunnel Syndrome: A Cross-sectional Study

Sponsor

Ahram Canadian University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05838820

Collaborator

(none)

Enrollment

Location

4.5

Anticipated Duration (Months)

11.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome	Diagnostic Test: Nine-Hole Peg Test Diagnostic Test: Jebsen-Taylor Hand Function Test

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Reliability of the Jebsen-Taylor Hand Function Test and the Nine-Hole Peg Test in Individuals With Carpal Tunnel Syndrome: A Cross-sectional Study

Anticipated Study Start Date :

May 18, 2023

Anticipated Primary Completion Date :

Sep 27, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Carpal Tunnel Syndrome (CTS) Group This group will consist of individuals diagnosed with carpal tunnel syndrome (CTS) who are 18 years of age or older and who are able to provide informed consent to participate in the study. The group will be recruited from a single center and will be asked to complete the Jebsen-Taylor Hand Function Test and the Nine-Hole Peg Test twice, with a 1-week interval between the two assessments. The aim is to establish the test-retest reliability of these tests in individuals with CTS. The group will include at least 50 participants and will be diverse in terms of age, gender, and race/ethnicity to ensure that the study findings are generalizable to a broader population.	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. Diagnostic Test: 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.

Arm

Intervention/Treatment

Carpal Tunnel Syndrome (CTS) Group

This group will consist of individuals diagnosed with carpal tunnel syndrome (CTS) who are 18 years of age or older and who are able to provide informed consent to participate in the study. The group will be recruited from a single center and will be asked to complete the Jebsen-Taylor Hand Function Test and the Nine-Hole Peg Test twice, with a 1-week interval between the two assessments. The aim is to establish the test-retest reliability of these tests in individuals with CTS. The group will include at least 50 participants and will be diverse in terms of age, gender, and race/ethnicity to ensure that the study findings are generalizable to a broader population.

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.

Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

Test-Retest Reliability of Jebsen-Taylor Hand Function Test and Nine-Hole Peg Test in Individuals with Carpal Tunnel Syndrome [1-week interval between the two assessments]
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.

Secondary Outcome Measures

Correlation with clinical measures [1-week interval between the two assessments]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Al Ḩayy Ath Thāmin	Giza	Egypt	3221405

Sponsors and Collaborators

Ahram Canadian University

Investigators

Study Chair: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Magdy ElMeligie, Lecturer of Physical Therapy and Director of Electromyography Lab, Ahram Canadian University

ClinicalTrials.gov Identifier:

NCT05838820

Other Study ID Numbers:

012/005988

First Posted:

May 3, 2023

Last Update Posted:

May 3, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carpal Tunnel Syndrome

Syndrome

Study Results

No Results Posted as of May 3, 2023