StrokeNCT06043869
Translation and Psychometric Properties of the Urdu Version of Tinetti Falls Efficacy Scale
An observational study of Stroke, run by University of Lahore at 1 site in Pakistan.
Trial summary
Falls are the most common cause of injuries and hospitalization for elderly people and can lead to a significant loss of independence. Even in the absence of serious injury, falls may lead seniors to restrict their activities outside of the home for fear of falling again.Tinetti's Falls Efficacy Scale (FES) is the… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke
- How many people
- 180 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Jun 2023to 8 Sep 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 40 to 65 years
- All sexes
- Adult, Older adult
Study population: Stroke (Ischemic, Hemiplegic both)
Who may be able to join
- Age 40 to 65 years
- Both gender
- Stroke
Who cannot join
- Critically ill patients who are on respirators
- Neurologically unstable patients
- Patients who cannot read and understand Urdu language
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Lahore Teaching Hospital
Lahore, Punjab Province, 55150
About this study
Official title: Translation and Psychometric Properties of the Urdu Version of Tinetti Falls Efficacy Scale in Stroke Patients
Falls are the most common cause of injuries and hospitalization for elderly people and can lead to a significant loss of independence. Even in the absence of serious injury, falls may lead seniors to restrict their activities outside of the home for fear of falling again.Tinetti's Falls Efficacy Scale (FES) is the most widely used measure of self-efficacy in studies on falls prevention. Mary E. Tinetti developed this scale to measure the fear of falling. The 10item scale was developed to assess confidence in performing daily activities without falling. Items are rated from 1 ¼ extreme confidence to 10 ¼ no confidence at all. The FES scale has been reported to have excellent internal reliability (Cronbach's alpha ranged between 0.89 and 0.99), with all items loading on a single factor.Test-retest reliability has been reported to be good (ranged from r ¼ 0.71 - 0.90).Criterion validity has been demonstrated by significant associations between FES scores and difficulty getting up after a fall, measures of balance and gait, and activity avoidance. In predictor studies, low FES scores were associated with falls restrictions in social functions and activities of daily living (ADL) reduced physical activity and mobility problems. Tinetti's Falls Efficacy Scale has been translated many languages like Chinese, Iranian, Persian etc. But the Urdu translation is not yet available. To measure the fear of falling in stroke patients Tinetti's Falls Efficacy Scale is a reliable and valid scale..In Neuro rehabilitation clinics the most common issue with the patients who come for rehabilitation is Stroke. So, it is highly required to translate valid and reliable instruments like Tinetti's Falls Efficacy Scale in to Urdu language. So, that patients will be able to understand the questionnaire into their native language and will be able to tell about the actual state of their condition.
Read the detailed description
Tinetti's Falls Efficacy scale is translated into many languages but Urdu version is yet not available. In neuro physiotherapy clinics majority of the patients comes with the problem of stroke. That's why there is a need to convert a valid and reliable instrument in to Urdu to measure the risk of falling after Stroke in Pakistani population. Reliability is about a methods consistency i.e. results can be reproduced when the research is repeated under the same conditions. For reliability Urdu Version of Tinetti's Falls Efficacy Scale for stroke will be applied two times by a physiotherapist to determine test-retest reliability. On the first day of assessment the physiotherapist will collect demographic data and patients will answer the questionnaire, Tinetti's Falls Efficacy Scale for stroke in Urdu will be reapplied 3 days later. Between two assessments, no treatment will be provided to minimize clinical differences. Tinetti's Falls Efficacy Scale (FES) is the most widely used measure of self-efficacy in studies on falls prevention. Mary E. Tinetti developed this scale to measure the fear of falling. The 10-item scale was developed to assess confidence in performing daily activities without falling. Items are rated from 1 ¼ extreme confidence to 10 ¼ no confidence at all. Reliability will be determined by test-retest reliability across repeated measures, internal consistency and measurement errors. Test-retest reliability will be determined by using an intra-class correlation coefficient (ICC) at 95% confidence intervals (CIs) and Internal consistency will be determined with Cronbach's alpha in this study. Validity is about the accuracy of a measure i.e. results really measures what they are supposed to measure. Validity determines whether the research truly measures that which it was intended to measure or how truthful the research results are. Construct validity will be assessed by comparing the scores of Tinetti's falls efficacy scale and Fear of Falling Avoidance-Behavior Questionnaire (FFABQ) in this study. All patients signed written informed consent forms and approvals were sought from the Ethics Committee of the University of Lahore. The translated Urdu version of Tinetti's Falls Efficacy Scale was then used for data collection.
- Conditions
- Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of Falling Avoidance-Behavior Questionnaire
The Fear of Falling Avoidance-Behavior Questionnaire (FOFABQ), often referred to as the FOFABQ, is a standardized assessment tool used to measure an individual's fear of falling and the extent to which this fear influences their behavior. It is commonly used in healthcare and research settings, particularly with older adults or individuals with a history of falls. Sum the scores for all the questions on the FOFABQ to obtain the respondent's total score. The total score represents the overall level of fear of falling and avoidance behavior. The interpretation of the FOFABQ score may vary depending on the specific version of the questionnaire used and the scoring system adopted in a particular study or clinical setting. Typically, higher scores on the FOFABQ indicate greater fear of falling and more avoidance behavior.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start8 Jun 2023
- Primary completion1 Sep 2023
- Study completion8 Sep 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 University of LahoreThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Myra Naeem, MSPTN*, Principal investigator, University of LahoreSamia Sarmad, tDPT, Study director, University of LahoreWaqar Afzal, PhD PT*, Study director, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043869
- Sponsor's protocol ID
- REC-UOL-454-07-2023
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Psychometric Properties of the Urdu Version of Tinetti Falls Efficacy Scale in Stroke Patients
- ClinicalTrials.gov ID
- NCT06043869
- Acronym / sponsor ID
- REC-UOL-454-07-2023
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 21 Sep 2023 (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.
Falls are the most common cause of injuries and hospitalization for elderly people and can lead to a significant loss of independence. Even in the absence of serious injury, falls may lead seniors to restrict their activities outside of the home for fear of falling again.Tinetti's Falls Efficacy Scale (FES) is the most widely used measure of self-efficacy in studies on falls prevention. Mary E. Tinetti developed this scale to measure the fear of falling. The 10item scale was developed to assess confidence in performing daily activities without falling. Items are rated from 1 ¼ extreme confidence to 10 ¼ no confidence at all. The FES scale has been reported to have excellent internal reliability (Cronbach's alpha ranged between 0.89 and 0.99), with all items loading on a single factor.Test-retest reliability has been reported to be good (ranged from r ¼ 0.71 - 0.90).Criterion validity has been demonstrated by significant associations between FES scores and difficulty getting up after a fall, measures of balance and gait, and activity avoidance. In predictor studies, low FES scores were associated with falls restrictions in social functions and activities of daily living (ADL) reduced physical activity and mobility problems. Tinetti's Falls Efficacy Scale has been translated many languages like Chinese, Iranian, Persian etc. But the Urdu translation is not yet available. To measure the fear of falling in stroke patients Tinetti's Falls Efficacy Scale is a reliable and valid scale..In Neuro rehabilitation clinics the most common issue with the patients who come for rehabilitation is Stroke. So, it is highly required to translate valid and reliable instruments like Tinetti's Falls Efficacy Scale in to Urdu language. So, that patients will be able to understand the questionnaire into their native language and will be able to tell about the actual state of their condition.
Detailed description
Tinetti's Falls Efficacy scale is translated into many languages but Urdu version is yet not available. In neuro physiotherapy clinics majority of the patients comes with the problem of stroke. That's why there is a need to convert a valid and reliable instrument in to Urdu to measure the risk of falling after Stroke in Pakistani population. Reliability is about a methods consistency i.e. results can be reproduced when the research is repeated under the same conditions. For reliability Urdu Version of Tinetti's Falls Efficacy Scale for stroke will be applied two times by a physiotherapist to determine test-retest reliability. On the first day of assessment the physiotherapist will collect demographic data and patients will answer the questionnaire, Tinetti's Falls Efficacy Scale for stroke in Urdu will be reapplied 3 days later. Between two assessments, no treatment will be provided to minimize clinical differences. Tinetti's Falls Efficacy Scale (FES) is the most widely used measure of self-efficacy in studies on falls prevention. Mary E. Tinetti developed this scale to measure the fear of falling. The 10-item scale was developed to assess confidence in performing daily activities without falling. Items are rated from 1 ¼ extreme confidence to 10 ¼ no confidence at all. Reliability will be determined by test-retest reliability across repeated measures, internal consistency and measurement errors. Test-retest reliability will be determined by using an intra-class correlation coefficient (ICC) at 95% confidence intervals (CIs) and Internal consistency will be determined with Cronbach's alpha in this study. Validity is about the accuracy of a measure i.e. results really measures what they are supposed to measure. Validity determines whether the research truly measures that which it was intended to measure or how truthful the research results are. Construct validity will be assessed by comparing the scores of Tinetti's falls efficacy scale and Fear of Falling Avoidance-Behavior Questionnaire (FFABQ) in this study. All patients signed written informed consent forms and approvals were sought from the Ethics Committee of the University of Lahore. The translated Urdu version of Tinetti's Falls Efficacy Scale was then used for data collection.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Stroke (Ischemic, Hemiplegic both)
Key inclusion criteria (3 listed)
- Age 40 to 65 years
- Both gender
- Stroke
Key exclusion criteria (3 listed)
- Critically ill patients who are on respirators
- Neurologically unstable patients
- Patients who cannot read and understand Urdu language
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
Fear of Falling Avoidance-Behavior Questionnaire
Time frame: 1 week
The Fear of Falling Avoidance-Behavior Questionnaire (FOFABQ), often referred to as the FOFABQ, is a standardized assessment tool used to measure an individual's fear of falling and the extent to which this fear influences their behavior. It is commonly used in healthcare and research settings, particularly with older adults or individuals with a history of falls. Sum the scores for all the questions on the FOFABQ to obtain the respondent's total score. The total score represents the overall level of fear of falling and avoidance behavior. The interpretation of the FOFABQ score may vary depending on the specific version of the questionnaire used and the scoring system adopted in a particular study or clinical setting. Typically, higher scores on the FOFABQ indicate greater fear of falling and more avoidance behavior.
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 21 Sep 2023.
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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.
Myra Naeem, MSPTN* principal investigator
University of Lahore
Samia Sarmad, tDPT study director
University of Lahore
Waqar Afzal, PhD PT* study director
University of Lahore
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 University of Lahore 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 21 Sep 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?
Fear of Falling Avoidance-Behavior Questionnaire (time frame: 1 week). 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 21 Sep 2023.