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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05449314
Other study ID # REC/FSD/0295
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 30, 2021
Est. completion date July 25, 2022

Study information

Verified date January 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Aim of the study is to translate and culturally adapt the modified Barthel index into Urdu language and to investigate the reliability and validity of this scale in Urdu speaking Stroke population for performance evaluation. Also check its correlation with Functional independence measure and Katz index of Activities of Daily Living.


Description:

The English version of the Barthel index will be translated and traditionally adapted as prior endorsement. In Activities of Daily Livings disabled stroke population, Urdu Version of Modified Barthel Index will distributed among sixty participants choose by convenience sampling technique based on pre-distinct inclusion and exclusion standards. To test inter and intra-observer reliability of the final Urdu Version of Modified Barthel Index will be completed on the same day, by two observers, and for the inter-observers evaluation, with an interval of 30 minute between the first and the second submission. Third evaluation will be carried out after 7 days by Observer-1, for intra-observer assessment. Data will be entered and analyzed using Statistical Package of Social Sciences Version 24. Core steadiness will be analyzed with Cronbach alpha value. Test-retest reliability will be evaluated using an intra-class correlation coefficient.The Urdu Version of Modified Barthel Index will be evaluated for content validity, construct validity, criterion validity and responsiveness.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 25, 2022
Est. primary completion date July 25, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male and female both genders - Adults between the ages of 18 and above - Patient suffering from Stroke - Ability to provide informed consent Exclusion Criteria: - Suffering from any cardiovascular pathologies - Any disorder of contagious infections - Any history of neurological disorders - Having any spinal deformity

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Pakistan Ripah International University Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Barthel Index Modified Barthel Index explained 10 tasks and scores are according to time and assistance needed by the patient between total score from 0 to 20.Lower score describes greater assistance, and larger score tells less assistance required by patient. 1st day
Primary Functional Independence Measure Functional Independence Measure was developed with 18-items that includes, 7-level ordinal scale, with 1 representing dependence and 7 representing independence. This outcome was designed to measure amount and level of help needed to perform Activities of Daily Living by disabled persons. 1st day
Primary Katz index of Activities of Daily Living The Katz Activities of Daily Living Index assesses basic activities of daily living. It does not assess more advanced activities of daily living. Katz developed another scale for instrumental activities of daily living such as heavy housework, shopping, managing finances and telephoning. 1st day
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