NCT06687031

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

9 months

First QC Date

November 12, 2024

Last Update Submit

November 12, 2024

Conditions

Keywords

Fall risk questionnaire, Psychometric, Reliability, Translation, Validity,

Outcome Measures

Primary Outcomes (4)

  • Urdu version of Fall Risk Questionnaire

    FRQ is very reliable and valid tool for assessing the risk of fall in older population. It is translated into different languages (Thai, Brazil, Chinese, Persian, Turkish, Arabic) due to its reliability and validity. It has 12 yes or no questions that assess different fall related risk factors in older adults. The answers are scored as yes=2 or no=0 for the first two questions while in remaining ten questions yes=1. Total score of fall risk questionnaire is 14 the score of 4 or greater than 4 indicates that older adult is at risk of falling.

    12 weeks

  • Berg balance scale

    It is reliable and valid tool to determine the balance of the individual through series of predetermined tasks. There are different version of berg balance scale (Brazilian, Persian, Russian, Itallian, Urdu). It has 14 items list (sit to stand , stand unsupported, sitting unsupported, sitting to stand transfers, standing with eyes closed, standing with feet close together, reaching forward with outstretched arm, retrieving objects from the floor, turning to look behind, turn 360 degree, place alternate foot on the floor, stand on one foot) with each item consists of five points ranging from 0 to 4. 0 means lowest level of function while 4 means highest level of function and it takes about 20 minutes to complete. Equipments require during performance are stop watch, a ruler,2 standard chairs one with arm arrest and one without arm rest a footstool or step and 15 ft walkway. A score of 56 indicates functional balance and a score of \<45 indicates individual may be at gr

    12 weeks

  • Time up and Go test

    Time up and go test is used to determine dynamic balance and it is a a reliable tool for assessing balance in older adult age above 65. In this test participant is sitting on a standard arm chair and we ask the patient to stand up when the instructor say go and then walk to the 3 meter line on the floor at normal pace and then turn and walk back to the chair at the normal pace and sit down again. On the word go start the timer on the stop watch and stop the timer when patient sit back on the chair and record the time. If patient score is equal or greater than 12 then he is at risk of falling.

    12 weeks

  • Five Times Sit to Stand test

    It is a reliable test to measure the strength of lower limb muscle along balance in older population . It is devised by Causka and McCarty. In this test patient is sitting in standard height chair and his both hands are placed on the opposite shoulder with back straight and instructed to do sit to stand five times as quickly as possible at the count of go and without their back or leg resting on the chair between the interval of repetition. Timer should start when instructor says start and stops when individual's buttock touches the seat of the chair after the last repetition. Inability to complete five repetition without assistance or use of upper extremity support indicates failure of the test any modification should be documented. The normal score for the 60 to 69 years age group is 11.4 sec and 12.6 sec for 70 to 79 years age group and 14.8 sec for 80 to 89 years age group.

    12 weeks

Eligibility Criteria

Age65 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

older population

You may qualify if:

  • 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.

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54660, Pakistan

Location

Related Publications (6)

  • 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.

    PMID: 22152267BACKGROUND
  • 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.

    PMID: 33208120BACKGROUND
  • 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.

    PMID: 36119553BACKGROUND
  • 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.

    PMID: 37107888BACKGROUND
  • 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.

    PMID: 35765037BACKGROUND
  • 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.

    PMID: 23523272BACKGROUND

Study Officials

  • Muhammad Kashif Shaffi, PhD-PT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Kashif Shaffi, PhD-PT

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 13, 2024

Study Start

November 10, 2024

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

November 13, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations