Translation, Cultural Adaptation and Validation of Urdu V... | NCT05125198

Studies
Translation, Cultural Adaptation and Validation of Urdu Version of VISA-A Questionnaire

NCT05125198

Sponsor

University of Lahore

Status

Completed

Last Update Posted

Jan 19, 2022Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Achilles Tendinopathy

Interventions

Not provided

Countries

Pakistan

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

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 17, 2021Actual

Primary Completion Date

Dec 15, 2021Actual

Completion Date

Dec 30, 2021Actual

First Submitted Date

Oct 15, 2021

First Submission Date that Met QC Criteria

Nov 7, 2021

First Posted Date

Nov 18, 2021Actual

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

Jan 17, 2022

Last Update Posted Date

Jan 19, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sana Akram, Assistant Professor (University Institute of Physical Therapy), University of LahorePrincipal Investigator

Lead Sponsor

University of LahoreOTHER

Collaborators

Not provided

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 is designed to translate and validate the VISA-A questionnaire to the Urdu language, to interpret its psychometric properties, and to determine the reliability of scores obtained from the population of Pakistan. The translated version of the gold standard tool will be used by the local population as well as Urdu-speaking immigrants across the globe to better understand and report the severity of their symptoms. Hence, to improve quality of life across cultures, there is a need of standard outcome measures in Urdu language.

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

80Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change being assessed in interpretation of Severity of Achilles tendinopathy.among participants using translated version of VISA-A questionnaire.	VISA-A is consisted of eight questions that measured the domains of pain, function in daily living, and sporting activity. Results range from 0 to 100, where 100 represents the perfect score	1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals aged over 18 years and both genders.
Athletic population with the diagnosis of unilateral mid-portion or insertional Achilles tendinopathy, paratendinosis, partial tendon rupture with or without retrocalcaneal bursitis.
With positive Painful arc sign and Royal London Hospital Test.
Healthy individuals.

Exclusion Criteria:

Complete rupture of Achilles tendon,
Pregnant women and those with any history of radicular pain or lower extremity injury
Previous surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Using the rule of Thumb: Minimum of 3 per items.
Total items in the questionnaire=8
As per rule of Thumb=8*5=40
n=40
*For better accuracy investigators will take sample size of 40 individuals with Achilles tendinopathy and 40 healthy ankles (Conventional group to assess known group validity).
So n=80

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Lahore		Lahore	Punjab Province	54000	Pakistan

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