- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05411003
Urdu Version Of Nottingham Extended Activities Of Daily Living Scale: Reliability And Validity Study
May 6, 2024 updated by: Riphah International University
Is Nottingham Extended Activities Of Daily Living Scale in Urdu Language a Reliable and Valid Tool to Assess the Level of Independence While Performing Activities of Daily Livings
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
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Faisalabad, Punjab, Pakistan, 38000
- Ripah International University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
67 years and older (Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Stroke population of Pakistan over 67 years of age
Description
Inclusion Criteria:
- Having age of 67 years or more
- Having stroke
- Both males and females
Exclusion Criteria:
- Neurological condition other than stroke
- Any fracture of lower extremity
- Any amputation of lower extremity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nottingham Extended Activities Of Daily Living Scale
Time Frame: 1st day
|
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
|
Frenchay Activities Index
Time Frame: 1st day
|
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
|
Modified Barthel Index
Time Frame: 1st day
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Muhammad Kashif, Riphah International University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2021
Primary Completion (Actual)
July 10, 2023
Study Completion (Actual)
July 12, 2023
Study Registration Dates
First Submitted
June 6, 2022
First Submitted That Met QC Criteria
June 6, 2022
First Posted (Actual)
June 8, 2022
Study Record Updates
Last Update Posted (Actual)
May 7, 2024
Last Update Submitted That Met QC Criteria
May 6, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-FSD-00270
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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