Validating and Assessing Reliability | NCT07338955

Studies
Validating and Assessing Reliability

NCT07338955

Sponsor

Bahria University

Status

Recruiting

Last Update Posted

Jan 14, 2026Actual

Enrollment

385Estimated

Phase

Not provided

Conditions

Upper Limb Disability

Interventions

All participants (Aviane)
data collection

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 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 3, 2025Actual

Primary Completion Date

Dec 10, 2025Actual

Completion Date

Jan 20, 2026Estimated

First Submitted Date

Dec 4, 2025

First Submission Date that Met QC Criteria

Jan 7, 2026

First Posted Date

Jan 14, 2026Actual

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 7, 2026

Last Update Posted Date

Jan 14, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rabia Khan, Assistant Professor, Bahria UniversityPrincipal Investigator

Lead Sponsor

Bahria UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 translate, culturally adapt, and validate the Urdu version of the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire for individuals with upper limb disabilities. Since no validated Urdu version currently exists, Urdu-speaking patients face communication barriers that may lead to inaccurate assessment and limited clinical decision-making. By ensuring semantic equivalence through forward-backward translation and expert review, the study seeks to develop a version that is both linguistically accurate and culturally appropriate.

Detailed Description

A cross-sectional research design will be used, involving adults aged 18-45 years diagnosed with upper limb functional limitations. Participants will complete both the Urdu and English DASH questionnaires to evaluate reliability and validity. Reliability will be assessed through internal consistency (Cronbach's alpha) and test-retest stability (ICC), while validity will be examined using expert scoring (CVI) and correlation with the original instrument. Data analysis will follow standard psychometric testing procedures using SPSS.

The expected outcome is a reliable, valid tool for assessing upper extremity disability in Urdu-speaking populations. This will improve clinical assessment, enhance patient communication, and support broader inclusion in rehabilitation research and practice.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

385 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

385Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Data will be collected from experienced physiotherpist	Other: All participants (Aviane) Other: data collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
All participants (Aviane)	Other	Data will be collected from patients having upper limb pain or disability	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reliability and validity	To assess the reliability and validity of the Urdu version of the DASH Questionnaire.	December 2025 to January 2026

Secondary Outcomes

Measure	Description	Time Frame
cultural adaptation	To ensure the cultural adaptation, response of the patient and to compare the results of DASH Questionnaire Urdu version with English version of DASH Questionnaire.	October 2025 to November2025

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with any upper limb disability or deformity . Able to read, understand and speak Urdu. Individuals with symptoms enduring for at least one week .

Exclusion Criteria:

Cognitive impairment or psychiatric illness that hinders understanding of the questionnaire.

Patients with congenital deformities. Refusal to give informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Patients with upper limb disability or pain for more than 4 weeks

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rabia Khan, Masters in Physiotherapy	Contact	+923452310047		iamrabiakhan@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University	Recruiting	Karachi	Sindh	75300	Pakistan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35665605	Result	Basakci Calik B, Demir P, Gur Kabul E, Caglayan BC, Keskin A, Karasu U. Validity and Reliability of the Turkish Version of the DASH-TR Questionnaire in Rheumatoid Arthritis Patients, Based on Rasch Analysis. Int J Rheum Dis. 2022 Aug;25(8):851-860. doi: 10.1111/1756-185X.14358. Epub 2022 Jun 6.
36739630	Result

ID	Term
C072593	ethinyl estradiol, levonorgestrel drug combination
D003625	Data Collection

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care