StrokeNCT05449314
Reliability and Validity Study of Urdu Version of Modified Barthel Index in Stroke Patients
An observational study of Stroke, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 25 Jul 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Urdu speaking population with Activities of Daily Living, balance, or gait impairments effected with Stroke
Who may be able to join
- Male and female both genders
- Adults between the ages of 18 and above
- Patient suffering from Stroke
- Ability to provide informed consent
Who cannot join
- Suffering from any cardiovascular pathologies
- Any disorder of contagious infections
- Any history of neurological disorders
- Having any spinal deformity
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Cultural Adaptation and Validation of Urdu Version of Modified Barthel Index to Assess the Independence of Pakistani Stroke Patients
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.
Read the detailed 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.
- Conditions
- Stroke
- Keywords
- Modified Barthel index, Urdu Version, Reliability, Validity, Cerebrovascular Disease, Stroke, Activities of Daily Living
- Medical subject headings
- Stroke, Cerebrovascular Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1st day
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.
Measured: 1st day
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.
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 Jul 2022
- Study start30 May 2021
- Primary completion25 Jul 2022
- Study completion25 Jul 2022
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
- Cross-sectional
- Enrolment
- 60 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
- NCT05449314
- Sponsor's protocol ID
- REC/FSD/0295
- Status last verified
- Jan 2023
- First submitted
- 4 Jul 2022
- Last updated
- 17 Jan 2023
- 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 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Adaptation and Validation of Urdu Version of Modified Barthel Index to Assess the Independence of Pakistani Stroke Patients
- ClinicalTrials.gov ID
- NCT05449314
- Acronym / sponsor ID
- REC/FSD/0295
- Conditions
- Stroke
- Keywords
- Modified Barthel index, Urdu Version, Reliability, Validity, Cerebrovascular Disease, Stroke, Activities of Daily Living
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 8 Jul 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.
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.
Detailed 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Urdu speaking population with Activities of Daily Living, balance, or gait impairments effected with Stroke
Key inclusion criteria (4 listed)
- Male and female both genders
- Adults between the ages of 18 and above
- Patient suffering from Stroke
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Suffering from any cardiovascular pathologies
- Any disorder of contagious infections
- Any history of neurological disorders
- Having any spinal deformity
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
Modified Barthel Index
Time frame: 1st day
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.
Functional Independence Measure
Time frame: 1st day
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.
Katz index of Activities of Daily Living
Time frame: 1st day
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.
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 17 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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 4 inclusion and 4 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 17 Jan 2023. 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?
Modified Barthel Index (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 17 Jan 2023; AzTrials last refreshed its copy on 1 Nov 2026.