Cross-Cultural Adaptation and Psychometric Validation of... | NCT05970692

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

NCT05970692

Sponsor

Ilke KARA

Status

Unknown status

Last Update Posted

Feb 22, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Carpal Tunnel Syndrome

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 26, 2023Actual

Primary Completion Date

Aug 13, 2024Estimated

Completion Date

Dec 30, 2024Estimated

First Submitted Date

Jul 24, 2023

First Submission Date that Met QC Criteria

Jul 24, 2023

First Posted Date

Aug 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2024

Last Update Posted Date

Feb 22, 2024Actual

Name	Class
Bitlis Eren University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Controls		Healthy individuals aged between 18-65 years old
CTS Group		CTS patients aged between 18-65 years old

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Atroshi-Lyrén 6-item symptoms scale	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

CTS patients aged between 18-65 years old

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tülay Çevik Saldıran, PhD	Contact	+90 (434) 222 83 32		tcsaldiran@beu.edu.tr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bitlis Eren University	Recruiting	Bitlis		13000	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002349	Carpal Tunnel Syndrome
D010146	Pain

Ancestor Terms

ID	Term
D020423	Median Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided