Clinical trial NCT06687031: Cross Cultural Adaptation and Psychometric Properties of Urdu Version of Fall Risk Questionnaire
Official title: Cross Cultural Adaptation and Psychometric Properties of Urdu Version of Fall Risk Questionnaire
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Older People
Keywords: Fall risk questionnaire, Psychometric, Reliability, Translation, Validity,
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: older population

Brief summary: Fall is an event that result a person coming to rest inadvertently on the ground or floor or other lower level. Fall and fall related injuries are very common in older population. Fall can cause potentially life threatening events that can lead to hospitalization and increase cost and burden on society and even lead to the death. Several tools are use for fall risk assessment but in current study we will use fall risk questionnaire that is translated in many languages that is Arabic, Persian, Brazil Turkish and Chinese but no study has translated the fall risk questionnaire into Urdu language. The objective of current study is to translate the fall risk questionnaire into Urdu to determine its reliability and validity in Urdu speaking older population of Pakistan. .

The study will be cross sectional in which original English version of questionnaire will be translated into Urdu language using five steps as described by beaten. The study will be conducted at Service hospital Lahore and Mian Munshi District Head Quarter hospital Lahore. In this study sample size of 120 participants is calculated based on previously published guidelines and according to previously described inclusion and exclusion criteria individuals with age 65 or above 65 who can speak and understand urdu will be included and individuals with any neurological or orthopedic problem that disturb their walking and balance will be excluded. For data collection two physiotherapist (assessor A and assessor B) will examine the enrolled individual separately using fall risk questionnaire, time up and go test, berg balance scale, 5 times sit to stand test and the assessor B will conduct examination 2 hours later to check the inter rater reliability .To determine the intra rater reliability assessor A will again conduct the examination after 7 to 10 days. After collection of data the statistical data analysis will be performed of the collected data using SPSS version 21 with p value will be set to be statistically significant at 0.05 to check the reliability and validity of the Urdu version of fall risk questionnaire. Pearson r will show the co relation of fall risk questionnaire with Berg balance scale, time up and Go test and five times sit to stand test and cronbach's value will show the internal consistency and interclass correlation coefficient ICC will assess the test retest reliability of fall risk questionnaire.

Detailed description: Fall is define as an event which causes a person to unintentionally rest on the ground or floor or lower level. Fall is a movement down that happens due to the gravity. It is the act of going down from upright position suddenly and involuntarily .Fall can occur in every population like in pediatric adults and in geriatric population. But it is very common in older adults aged 65 years and above. The aging population constitute a large and increasing percentage of the world population .When people grow older they experience deterioration in their physiological system and functional status decline until they become frail.

One out of four individual with age 65 years or above experiences at least one fall in every year.(1) In a review of 104 studies with a total sample people of the world is 26.5%(95%CI 23.4-29.8)(2)the present studies show that prevalence of fall in Pakistan is 42.6%(3).In studies 62% of older people were found to have one to two falls resulting in increase risk of fall and consequent injuries. Death in 84.6% of older adult result from fall related injuries than from other causes and 38.19% hospital admission are consequences of fall .

There are different causes of fall it may be due to intrinsic factors( age, impaired balance and gait, decrease muscle strength, impaired vision, cognition, dizziness, depression) and extrinsic factors(medications, opioids, antidepressant, anesthesia ,,inappropriate shoes household setting unsafe furniture, dim light ,presence of loss rug, lack of safety handrails).

Fall can result in fractures, particularly of the hip, wrist, arm, and ankle that can be debilitating and may require surgery or prolonged rehabilitation. It can lead to head injuries, including concussions and traumatic brain injuries (TBIs), which can have serious long-term consequences, especially in older adults. Fall can cause bruises, sprains, strains, and other soft tissue injuries, which may be painful and limit mobility. After experiencing a fall, older adults may develop a fear of falling again,(bisphobia) leading to decreased activity levels, loss of confidence, and social isolation. Severe falls can result in a loss of independence if they lead to disabilities or impairments that affect daily activities and mobility. It often result in hospitalization, which can lead to complications such as infections, pressure ulcers, and deconditioning, particularly in older adults with pre-existing health conditions.. Fall can have psychological effects, including anxiety, depression, and a decrease in overall well-being, affecting both the individual and their caregivers or family members Several tools are commonly use for fall risk assessment in the older population that include downton fall risk, mobility interaction fall chart, St.Thomas risk assessment tool, time up and Go test TUG, Berg balance scale BBS, five times sit to stand test(5TSTST) performance oriented mobility assessment POMA, Fall efficacy scale FES the, Morse Fall scale, Hendrich ll fall risk model, fall risk assessment tool (FRAT) the mini BESTest (Mini balance evaluation system test).(4) In current study we will use fall risk questionnaire FRQ for assessment of the fall in older population. Rubenstein at al developed and validated the simple, brief, and fast 12-question self-rated Fall Risk Questionnaire(FRQ).It has 12 yes or no question the scoring of yes for the first two question is 2 (yes=2)while yes=1 in the remaining 10 questions and No=0 in all 12 questions. If the participants score is 4 or greater than 4 it means he is at risk of fall.

Fall risk questionnaire is translated in to many languages due to its reliability and validity it is translated into Arabic, Thai, brazil, Turkish, Protégées, Persian and Chinese language. More than 65 million people worldwide speak Urdu, mostly from Pakistan and India. Moreover, Urdu is national language of Pakistan. In Pakistan most of the people don't read or understand English very well specially the older population, so different questionnaire should be translated into Urdu. Therefore, the current study is aim at determining the validity and reliability of Urdu translation of fall risk questionnaire FRQ in the context of its acceptability, internal consistency, reliability, interrater reliability, and construct validity in older population.

Eligibility criteria: Inclusion Criteria:

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Inclusion Criteria:

* Both male and female gender will be included.
* Age of the individuals will be 65 to 80 year.
* Individuals can ambulate without using assistive devices.
* Individuals can speak Urdu.
* Individuals can understand the command.
* Individuals who don't have communication problem.
* Individuals having mini mental score equal and greater than 24.

Exclusion Criteria:

Individuals with neurological and orthopedic problem that disturb their balance and walking.

* Individuals with cardiovascular problem or uncontrolled hypertension.
* Individual who are alcoholic or any drug addict.
* Individuals who undergo chemotherapy or radiotherapy .

Primary outcomes:
measure: Urdu version of Fall Risk Questionnaire
timeFrame: 12 weeks
measure: Berg balance scale
timeFrame: 12 weeks
measure: Time up and Go test
timeFrame: 12 weeks
measure: Five Times Sit to Stand test
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif Shaffi, PhD-PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rubenstein LZ, Vivrette R, Harker JO, Stevens JA, Kramer BJ. Validating an evidence-based, self-rated fall risk questionnaire (FRQ) for older adults. J Safety Res. 2011 Dec;42(6):493-9. doi: 10.1016/j.jsr.2011.08.006. Epub 2011 Nov 17.
citation: Kitcharanant N, Vanitcharoenkul E, Unnanuntana A. Validity and reliability of the self-rated fall risk questionnaire in older adults with osteoporosis. BMC Musculoskelet Disord. 2020 Nov 18;21(1):757. doi: 10.1186/s12891-020-03788-z.
citation: Argyrou C, Dionyssiotis Y, Galanos A, Kantaidou I, Vlamis J, Triantafyllopoulos IK, Lyritis GP, Dontas IA, Chronopoulos E. Development and validation of a fall risk Questionnaire in Greek community-dwelling individuals over 60 years old. J Frailty Sarcopenia Falls. 2022 Sep 1;7(3):133-146. doi: 10.22540/JFSF-07-133. eCollection 2022 Sep.
citation: Alharbi AA, Al Amer HS, Albalwi AA, Muthaffar MY, Alshehre YM, Albalawi HF, Alshaikhi TE. Cross-Cultural Adaptation and Psychometric Properties of the Arabic Version of the Fall Risk Questionnaire. Int J Environ Res Public Health. 2023 Apr 21;20(8):5606. doi: 10.3390/ijerph20085606.
citation: Salari N, Darvishi N, Ahmadipanah M, Shohaimi S, Mohammadi M. Global prevalence of falls in the older adults: a comprehensive systematic review and meta-analysis. J Orthop Surg Res. 2022 Jun 28;17(1):334. doi: 10.1186/s13018-022-03222-1.
citation: Ambrose AF, Paul G, Hausdorff JM. Risk factors for falls among older adults: a review of the literature. Maturitas. 2013 May;75(1):51-61. doi: 10.1016/j.maturitas.2013.02.009. Epub 2013 Mar 22.