Carpal Tunnel SyndromeNCT05838820
Hand Function Tests in Carpal Tunnel Syndrome: A Cross-sectional Study
An observational study of Carpal Tunnel Syndrome, run by Ahram Canadian University at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Nine-Hole Peg Test and Jebsen-Taylor Hand Function Test
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 18 May 2023to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
About this study
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
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
- Being tested
- Nine-Hole Peg Test, Jebsen-Taylor Hand Function Test
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nine-Hole Peg TestDiagnostic 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 TestDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Nine-Hole Peg Test; Diagnostic Test: Jebsen-Taylor Hand Function Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-week interval between the two assessments
Secondary outcomes (1)
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.
Measured: 1-week interval between the two assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start18 May 2023 (estimated)
- Primary completion27 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study chair, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838820
- Sponsor's protocol ID
- 012/005988
- Status last verified
- Apr 2023
- First submitted
- 19 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (IPD) collected during this study will be available upon reasonable request. Requests for access to the data should be submitted via email to mohamed.elmeligie@acu.edu.eg. All requests will be reviewed by the study investigators to ensure that they are reasonable and consistent with the ethical principles of the study. Access to the data will be granted in compliance with applicable laws and regulations, and with appropriate safeguards to protect the privacy and confidentiality of study participants.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05838820
- Acronym / sponsor ID
- 012/005988
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 18 May 2023 (estimated)
- Primary completion
- 27 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carpal Tunnel Syndrome (CTS) Group | – | Diagnostic Test: Nine-Hole Peg Test, Diagnostic Test: Jebsen-Taylor Hand Function TestThis 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nine-Hole Peg TestThe 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 | Carpal Tunnel Syndrome (CTS) Group |
| Jebsen-Taylor Hand Function Testis 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. | Diagnostic test | Carpal Tunnel Syndrome (CTS) Group |
Primary outcome
Test-Retest Reliability of Jebsen-Taylor Hand Function Test and Nine-Hole Peg Test in Individuals with Carpal Tunnel Syndrome
Time frame: 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.
1 secondary outcome
Correlation with clinical measures
Time frame: 1-week interval between the two assessments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) collected during this study will be available upon reasonable request. Requests for access to the data should be submitted via email to mohamed.elmeligie@acu.edu.eg. All requests will be reviewed by the study investigators to ensure that they are reasonable and consistent with the ethical principles of the study. Access to the data will be granted in compliance with applicable laws and regulations, and with appropriate safeguards to protect the privacy and confidentiality of study participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal Fawzy, Ph.d study chair
Faculty of Physical Therapy, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Ahram Canadian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-Retest Reliability of Jebsen-Taylor Hand Function Test and Nine-Hole Peg Test in Individuals with Carpal Tunnel Syndrome (time frame: 1-week interval between the two assessments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.