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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05411003
Other study ID # REC-FSD-00270
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 30, 2021
Est. completion date July 12, 2023

Study information

Verified date May 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to know the validity and reliability as well as to translate and culturally adapt the Nottingham Extended Activities Of Daily Living Scale into Urdu language in Pakistani population of Stroke. This study also aims to correlate the scale with the Modified Barthel Index and Frenchay Activities Index.


Description:

As per previous recommendation the English version of Nottingham Extended Activities Of Daily Living Scale will be translated into Urdu and it will be culturally adapted. Nottingham Extended Activities Of Daily Living Scale will be given to eighty individuals of stroke population which were selected on the basis of convenience sampling and the criteria of inclusion and exclusion. Study will investigate both inter-observer and intra-observer reliability of Nottingham Extended Activities Of Daily Living Scale, Modified Barthel Index and Frenchay Activities Index; the 2 set of questionnaire designed will be given to the participants on the same day to be filled, by two observers. And with a gap of half an hour between distributions of first two forms questionnaires will be given for inter-observer assessment. And after a time period of one week a third assessment will be collected by the first observer (intra-observer assessment). Statistical Package of Social Sciences Version 24 will be used for data entry and analysis. Cronbach alpha value will be used for checking internal consistency and intra-class correlation coefficient will be used to analyze test retest reliability.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date July 12, 2023
Est. primary completion date July 10, 2023
Accepts healthy volunteers No
Gender All
Age group 67 Years and older
Eligibility Inclusion Criteria: 1. Having age of 67 years or more 2. Having stroke 3. Both males and females Exclusion Criteria: 1. Neurological condition other than stroke 2. Any fracture of lower extremity 3. Any amputation of lower extremity

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 Nottingham Extended Activities Of Daily Living Scale The purpose of development of Nottingham Extended Activities Of Daily Living Scale was to use it for stroke patients. Each question on the scale is graded either 0 which means patient cannot perform task, 1 which means that patient can do activity but with assistance, 2 which states that task can be performed but with difficulty, 3 which means that he or she can perform the activity on his or her own easily. The score ranges from 0-66. 1st day
Primary Frenchay Activities Index The Frenchay Activities Index is a tool for assessing instrumental activities of daily living in stroke patients. It is based upon the frequency in which activities are performed. Frenchay Activities Index scores vary from 0 (inactive) to 45 (very active), with 0-15 indicating inactivity, 16-30 indicating moderate activity, and 31-45 indicating extreme activity. A score of 18 or more than 18 was used to predict minor impairment following a stroke. 1st day
Primary Modified Barthel Index The Barthel modified index scale is used to assess behavior related to daily tasks in stroke patients or those with other debilitating conditions. Each activity is given a score ranging from 0 (unable to complete task) to 5, 10, or 15 (highest) (fully independent- exact score depends on the activity being evaluated). Summing the scores for each of the items yields a total score. 1st day
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