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

Sponsor
Ilke KARA (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05970692
Collaborator
Bitlis Eren University (Other)
100
Enrollment
1
Location
8
Anticipated Duration (Months)
12.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale
    Anticipated Study Start Date :
    Aug 1, 2023
    Anticipated Primary Completion Date :
    Dec 13, 2023
    Anticipated Study Completion Date :
    Mar 30, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy Controls

    Healthy individuals aged between 18-65 years old
    CTS Group

    CTS patients aged between 18-65 years old

    Outcome Measures

    Primary Outcome Measures

    1. Atroshi-Lyrén 6-item symptoms scale [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bitlis Eren University Bitlis Turkey 13000

    Sponsors and Collaborators

    • Ilke KARA
    • Bitlis Eren University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ilke KARA, Co-Principal Investigator, Dokuz Eylul University
    ClinicalTrials.gov Identifier:
    NCT05970692
    Other Study ID Numbers:
    • BEU-KTS-01
    First Posted:
    Aug 1, 2023
    Last Update Posted:
    Aug 1, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ilke KARA, Co-Principal Investigator, Dokuz Eylul University
    Carpal Tunnel Syndrome
    Pain
    Additional relevant MeSH terms:
    Carpal Tunnel Syndrome

    Study Results

    No Results Posted as of Aug 1, 2023