StrokeNCT05411003
Urdu Version Of Nottingham Extended Activities Of Daily Living Scale: Reliability And Validity Study
An observational study of Stroke, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 67 years and older
- Conditions the study is for
- Stroke
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 12 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 67 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Stroke population of Pakistan over 67 years of age
Who may be able to join
- Having age of 67 years or more
- Having stroke
- Both males and females
Who cannot join
- Neurological condition other than stroke
- Any fracture of lower extremity
- Any amputation of lower extremity
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Keywords
- Nottingham Extended Activities Of Daily Living Scale, Urdu Version, Reliability, Validity, Stroke, Neurological Disorders, Activities of Daily Living
- Medical subject headings
- Stroke, Nervous System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1st day
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.
Measured: 1st day
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.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start30 May 2021
- Primary completion10 Jul 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411003
- Sponsor's protocol ID
- REC-FSD-00270
- Status last verified
- May 2024
- First submitted
- 6 Jun 2022
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05411003
- Acronym / sponsor ID
- REC-FSD-00270
- Conditions
- Stroke
- Keywords
- Nottingham Extended Activities Of Daily Living Scale, Urdu Version, Reliability, Validity, Stroke, Neurological Disorders, Activities of Daily Living
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 67 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Stroke population of Pakistan over 67 years of age
Key inclusion criteria (3 listed)
- Having age of 67 years or more
- Having stroke
- Both males and females
Key exclusion criteria (3 listed)
- Neurological condition other than stroke
- Any fracture of lower extremity
- Any amputation of lower extremity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Kashif study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nottingham Extended Activities Of Daily Living Scale (time frame: 1st day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.