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

NCT05838820 | Unknown

• 1 other identifier: 012/005988
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation with clinical measures

  1-week interval between the two assessments

Study Arms (1)

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; Diagnostic Test: Jebsen-Taylor Hand Function Test

Interventions

Nine-Hole Peg Test DIAGNOSTIC_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.

Carpal Tunnel Syndrome (CTS) Group

Jebsen-Taylor Hand Function Test DIAGNOSTIC_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.

Carpal Tunnel Syndrome (CTS) Group

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 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. Participants will be recruited from a single center and will be diverse in terms of age, gender, and race/ethnicity to ensure that the study findings are generalizable to a broader population. Participants will be excluded from the study if they have a 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, or inability to comply with study procedures or follow-up requirements.

You may qualify if:

• Individuals diagnosed with carpal tunnel syndrome (CTS)
• years of age to 60 years old
• Able to provide informed consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

Location

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

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY CHAIR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

+201064442032; mohamed.elmeligie@acu.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 3, 2023
• Study Start: May 18, 2023
• Primary Completion: September 27, 2023
• Study Completion: October 1, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the trial ends and up to 1 year post trial.
• Access Criteria: via email to mohamed.elmeligie@acu.edu.eg

Locations

EG (1)