StrokeNCT05431842
Urdu Version of Functional Gait Assessment 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 study is to translate and culturally adapt Functional Gait Assessment Scale into Urdu language and to investigate the reliability and validity in Pakistani Stroke patients. Also check its correlation with Berg Balance Scale and Barthel Index Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 160 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 20 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pakistani population post-stroke over the age of 18 years or older.
Who may be able to join
- Age at least 18 years
- Post stroke patients past 3 months
- Both gender patients are included
Who cannot join
- Patient suffering from any neurological disorder
- Patient suffering from any musculoskeletal disorder
- Patients who are post stroke less than 3 months
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Analysis of Reliability and Validity of Urdu Version of Functional Gait Assessment Scale Among Pakistani Geriatric Population
The aim of study is to translate and culturally adapt Functional Gait Assessment Scale into Urdu language and to investigate the reliability and validity in Pakistani Stroke patients. Also check its correlation with Berg Balance Scale and Barthel Index
Read the detailed description
The English version of the Functional Gait Assessment Scale will be translated and culturally adapted as per previous recommendation. In geriatric population, Urdu Version of Functional Gait Assessment Scale will distributed among 160 participants choose by convenience sampling technique based on pre-defined inclusion and exclusion criteria.To test inter and intra-observer reliability of the final Urdu Version of Functional Gait Assessment Scale, Barthel Index and Berg Balance Scale, questionnaire will be filled on the same day. Data will be entered and analyzed using Statistical Package of Social Sciences Version 24. Internal consistency will be analyzed with Cronbach alpha value. Test- retest reliability will be assessed for intra-class correlation coefficient. The Urdu Version of Functional Gait Assessment Scale was evaluated for content validity, construct validity, criterion validity and responsiveness.
- Conditions
- Stroke
- Keywords
- Functional Gait Assessment Scale, Urdu Version, Reliability, Validity, Stroke, Geriatric Population
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Gait Assessment Scale
Functional Gait Assessment Scale is used to evaluate the constructions of balance and gait in ambulatory stroke patients. Number of Test Items: 10 Scoring: Each item is scored on an ordinal scale from 0 - 3, with 0 = severe impairment, 1 = moderate impairment, 2 = mild impairment, 3 = normal ambulation, Thus, the highest score is 30/30.
Measured: 1st day
Barthel Index
Barthel Index is use to assess the level of independence and autonomy of stroke patient in performing ADLs. It is a list of 10 elementary ADLs: feeding, grooming, bathing, dressing, bowel and bladder care, toilet use, ambulation, transfers, and stair climbing. The activities are rated through time taken and assistance used by patient. Score ranges from 0-100.
Measured: 1st day
Berg Balance Scale
the berg balance scale is an objective assessment of balance performance based on 14 items common to daily activities. it is a 14 items scale that rate 0 (unable to perform) to 4 (normal performance) for each item. the total score is 56 points, high score higher balance ability
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 posted24 Jun 2022
- Study start30 May 2021
- Primary completion15 Jul 2023
- Study completion20 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
- Cross-sectional
- Enrolment
- 160 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
- NCT05431842
- Sponsor's protocol ID
- REC-FSD-00265
- Status last verified
- May 2024
- First submitted
- 20 Jun 2022
- Last updated
- 8 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Reliability and Validity of Urdu Version of Functional Gait Assessment Scale Among Pakistani Geriatric Population
- ClinicalTrials.gov ID
- NCT05431842
- Acronym / sponsor ID
- REC-FSD-00265
- Conditions
- Stroke
- Keywords
- Functional Gait Assessment Scale, Urdu Version, Reliability, Validity, Stroke, Geriatric Population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 24 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 study is to translate and culturally adapt Functional Gait Assessment Scale into Urdu language and to investigate the reliability and validity in Pakistani Stroke patients. Also check its correlation with Berg Balance Scale and Barthel Index
Detailed description
The English version of the Functional Gait Assessment Scale will be translated and culturally adapted as per previous recommendation. In geriatric population, Urdu Version of Functional Gait Assessment Scale will distributed among 160 participants choose by convenience sampling technique based on pre-defined inclusion and exclusion criteria.To test inter and intra-observer reliability of the final Urdu Version of Functional Gait Assessment Scale, Barthel Index and Berg Balance Scale, questionnaire will be filled on the same day. Data will be entered and analyzed using Statistical Package of Social Sciences Version 24. Internal consistency will be analyzed with Cronbach alpha value. Test- retest reliability will be assessed for intra-class correlation coefficient. The Urdu Version of Functional Gait Assessment Scale was 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
- Pakistani population post-stroke over the age of 18 years or older.
Key inclusion criteria (3 listed)
- Age at least 18 years
- Post stroke patients past 3 months
- Both gender patients are included
Key exclusion criteria (3 listed)
- Patient suffering from any neurological disorder
- Patient suffering from any musculoskeletal disorder
- Patients who are post stroke less than 3 months
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
Functional Gait Assessment Scale
Time frame: 1st day
Functional Gait Assessment Scale is used to evaluate the constructions of balance and gait in ambulatory stroke patients. Number of Test Items: 10 Scoring: Each item is scored on an ordinal scale from 0 - 3, with 0 = severe impairment, 1 = moderate impairment, 2 = mild impairment, 3 = normal ambulation, Thus, the highest score is 30/30.
Barthel Index
Time frame: 1st day
Barthel Index is use to assess the level of independence and autonomy of stroke patient in performing ADLs. It is a list of 10 elementary ADLs: feeding, grooming, bathing, dressing, bowel and bladder care, toilet use, ambulation, transfers, and stair climbing. The activities are rated through time taken and assistance used by patient. Score ranges from 0-100.
Berg Balance Scale
Time frame: 1st day
the berg balance scale is an objective assessment of balance performance based on 14 items common to daily activities. it is a 14 items scale that rate 0 (unable to perform) to 4 (normal performance) for each item. the total score is 56 points, high score higher balance ability
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 8 May 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
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Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
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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 8 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?
Functional Gait Assessment 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 8 May 2024.