Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale

February 20, 2024 updated by: Ilke KARA
This study aims to develop Turkish version of the Atroshi-Lyrén 6-item symptoms scale (A-L scale) and to perform validity and reliability evaluations.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Bitlis, Turkey, 13000
        • Recruiting
        • Bitlis Eren University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

CTS patients aged between 18-65 years old

Description

Inclusion Criteria:

  • Aged between 18-65 years old,
  • Had symptoms of numbness, tingling, weakness and pain in the hands for at least 1 month,
  • Assessed through provocation tests and physical examination to match the median nerve distribution.

Exclusion Criteria:

  • Not willing to participate in the study,
  • Clinical or electrophysiological signs of proximal nerve compression,
  • Diabetes or other metabolic disease,
  • Rheumatoid arthritis or other general inflammatory diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy Controls
Healthy individuals aged between 18-65 years old
CTS Group
CTS patients aged between 18-65 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atroshi-Lyrén 6-item symptoms scale
Time Frame: 1 week
The A-L scale consists of 6 items that inquire about severity and frequency of night and daytime numbness and tingling and pain. For each patient the item responses are scored from 1 (best) to5 (worst) and then averaged for the 6 items to yield a total score (only 1 missing item response is allowed)
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ilke KARA

Collaborators

Bitlis Eren University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2023

Primary Completion (Estimated)

August 13, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEU-KTS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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