FallNCT04577365
Validation of a New Scale of Balance Recovery Confidence for Community-dwelling Older Adults
An observational study of Fall and Self Efficacy, run by Queen Margaret University at 1 site in Singapore.
Trial summary
Introduction: Patient-reported outcome measures (PROMs) provide clinicians with a greater understanding of patients' perceived ability in their physical performance. Existing PROMs on falls efficacy provide meaningful information about the perceived ability in older people to perform common activities of daily living… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall, Self Efficacy
- How many people
- 200 participants
- Where
- 1 siteSingapore
- Study dates
- 22 Feb 2021to Dec 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Community sample
Who may be able to join
- 65-years and older,
- Living in the community,
- Functionally independent with or without the use of a walking aid and be able to read,
- Write and communicate in English.
Who cannot join
- Require any physical assistance from another person to walk within the home,
- Presenting with clinical observable severe cognitive impairment.
- Unable to provide written consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore Institute of Technology
Singapore, 138683
Shawn Soh, 65-96997689, shawn.soh@singaporetech.edu.sg
About this study
Introduction: Patient-reported outcome measures (PROMs) provide clinicians with a greater understanding of patients' perceived ability in their physical performance. Existing PROMs on falls efficacy provide meaningful information about the perceived ability in older people to perform common activities of daily living without falling. However, the perceived ability to recover the balance from a slip, a trip, or volitional movements has been inadequately assessed. Balance recovery confidence relates to the judgement of self-reactive ability. The scale of balance recovery confidence (BRC) is a new PROM that measures perceived balance recovery self-efficacy. The purpose of the study protocol is to describe the first psychometric evaluation of BRC's measurement properties.
Methods and analysis: This study is a validation phase of a newly developed PROM conducted in Singapore. Two hundred community-dwelling older adults, aged 65 years and older, will complete five self-reported instruments (BRC), Activities-specific Balance Confidence Scale (ABC), Falls Efficacy Scale-International (FES-I), Late-Life Function and Disability Instrument-Function (LLDI-F) and Global Perceived Effect (GPE) and three performance measures (Hand strength dynamometer, 30-second Chair Stand, Mini BESTest). Classical test theory methods will assess acceptability, data completeness, targeting of the items, scaling assumptions, internal consistency reliability and construct validity. Factor analysis will establish unidimensionality. Rasch analysis will evaluate item fit, differential item functioning, response scale ordering, targeting of persons and items and the reliability.
Read the detailed description
Introduction: This study aims to conduct the first evaluation of measurement properties in the scale of balance recovery confidence. There are several measurement properties such as unidimensionality, validity (to what extent does the instrument measure the construct it purports to measure) and reliability (the degree to which measurement is free from error) of the PROM that is needed to be studied.
This psychometric validation aims to provide evidence that the PROM can be purposefully used in practice, given that rigorous methods have been applied for the development and validation of the BRC. For the study, balance recovery confidence is defined as the perceived ability to recover one's balance from perturbations, such as a slip, a trip, or a loss of balance that can occur in common, everyday activities. This focus will leave little ambiguity about precisely what is being measured. The resulting questionnaire is intended to be approximately 20 questions and should not take longer than 10 min to complete. The instrument is not intended to be used as a diagnostic tool of impaired specific balance recovery mechanisms. The BRC allows clinicians and researchers to quantifiably determine the balance recovery confidence in older adults and use the scale as a conduit for understanding older people's perspectives when encountering different perturbations during their daily activities.
The objectives are to:
- To evaluate the measurement properties of the BRC, i.e. acceptability, targeting, scaling assumptions and reliability using Classical Test Theory (CTT), the internal scale structure using Rasch measurement theory in the Singapore community-dwelling older adults.
- To assess the construct validity of the refined BRC against commonly used PROMs and performance measures in the Singapore community-dwelling older adults.
- To refine the items, response categories, and scale structure of the BRC using Rasch measurement theory in an English-speaking sample of community-dwelling older adults in Singapore.
Methods: Participants will attend two sessions in the study. In the first session, the researcher will use a measurement data form to record the participants' results of four questionnaires: BRC, ABC, FES-I, LLFDI-F and three performance measures: Jamar hand strength dynamometer, 30-second chair stand test and Mini BESTest. After seven days, participants will attend the second session to complete the BRC, and the GPE scale which will be used to ensure participants' perception of their abilities remained unchanged during the seven days. The time interval of 7-day had been reported to be sufficient to minimise recall bias. Participants will be asked if they have had experienced a fall, near-fall, or encountered any incident that might affect their balance recovery ability over the past seven days.
Statistical analysis: Quantitative data will be analysed and interpreted through two measurement test theories using IBM SPSS Statistic V.26.0 and Winsteps V.4.5.0. Classical test theory is a traditional quantitative approach to test the validity and reliability of a scale based on its items. This approach is based on the assumption that every observed score is a function of an individual's true score and random error. In contrast, RA works on the probability of a person's level on an item is a function of the person's ability and of the difficulty of the item. RA evaluates a scale against a mathematical measurement model and analyses the scale at the level of each item, and each person. Measurement properties including unidimensionality, internal structure, validity and reliability will be evaluated.
- Conditions
- Fall, Self Efficacy
- Keywords
- Accidental Falls, patient outcome assessment, postural balance, self-efficacy
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale of Balance Recovery Confidence
The scale of balance recovery confidence measures the perceived balance recovery self-efficacy in community-dwelling older adults. A response option ranged from 0 to 10 is listed with 10 indicating "Highly certain can do" and 0 refers to "Cannot do at all". The outcome measure is administered on Day 1 and Day 7.
Measured: 5 minutes
Activities-specific Balance Confidence Scale
The Activities-specific Balance Confidence scale assesses older adults' confidence that they will not fall or lose their balance when performing several progressively challenging balance and mobility tasks. The response option ranged from 0% (no confidence) to 100% (complete confidence). The outcome measure is administered on Day 1
Measured: 5 minutes
Falls Efficacy Scale - International
The Falls Efficacy Scale- International measures fear of falling or "concerns about falling" relating to basic and more demanding activities both physical and social. The response option ranged from 1-4 depicted by 1 for being not at all concerned, 2 for being somewhat concerned, 3 for being fairly concerned and 4 for being very concerned. The outcome measure is administered on Day 1
Measured: 5 minutes
Late-Life Function and Disability Instrument-Function component
The Late-Life Function and Disability Instrument-Functional component of the instrument evaluates self-reported difficulty a person has in performing activities of daily living tasks. Factors that may influence the difficulty in task performance include pain, fatigue, fear, weakness, soreness, ailment, health conditions, and disabilities.There are 32 items with response options of "none," "a little," "some," "quite a lot," and "cannot do." An additional eight items will be completed by those who use canes or walkers. The outcome measure is administered on Day 1
Measured: 5 minutes
Secondary outcomes (3)
Jamar hand strength dynamometer
The handheld dynamometer provides a quantitative measure of isometric grip strength of the hand by determining the amount of static force that the hand can squeeze around a dynamometer. The outcome measure is administered on Day 1
Measured: 10 minutes
30-second chair stand test
A quantitative measure used as test functional lower extremity strength as well as to obtain an indicator of functional independence with repeated performance of sit to stand from a chair within 30 seconds. The outcome measure is administered on Day 1
Measured: 10 minutes
Mini BESTest
The Mini BESTest assesses "anticipatory postural adjustment", "postural responses", "sensory orientation" and "balance during gait". The outcome measure is administered on Day 1.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start22 Feb 2021
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FallStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Institute of Technology
- Responsible party
- Principal investigator, Shawn Leng-Hsien Soh, Queen Margaret University
- Investigators
- Shawn Soh, Principal investigator, Singapore Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577365
- Sponsor's protocol ID
- REP0220
- Status last verified
- Nov 2021
- First submitted
- 30 Sep 2020
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be shared
Publications
Tokur D, Grimmer M, Seyfarth A. Review of balance recovery in response to external perturbations during daily activities. Hum Mov Sci. 2020 Feb;69:102546. doi: 10.1016/j.humov.2019.102546. Epub 2019 Dec 31.
PubMed 31989948Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239.
PubMed 2229948Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
PubMed 7814786Simpson JM, Worsfold C, Fisher KD, Valentine JD. The CONFbal scale: a measure of balance confidence--a key outcome of rehabilitation. Physiotherapy. 2009 Jun;95(2):103-9. doi: 10.1016/j.physio.2008.12.004. Epub 2009 Mar 24.
PubMed 19627691Horak FB, Wrisley DM, Frank J. The Balance Evaluation Systems Test (BESTest) to differentiate balance deficits. Phys Ther. 2009 May;89(5):484-98. doi: 10.2522/ptj.20080071. Epub 2009 Mar 27.
PubMed 19329772Jette AM, Haley SM, Coster WJ, Kooyoomjian JT, Levenson S, Heeren T, Ashba J. Late life function and disability instrument: I. Development and evaluation of the disability component. J Gerontol A Biol Sci Med Sci. 2002 Apr;57(4):M209-16. doi: 10.1093/gerona/57.4.m209.
PubMed 11909885Kamper SJ, Ostelo RW, Knol DL, Maher CG, de Vet HC, Hancock MJ. Global Perceived Effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status. J Clin Epidemiol. 2010 Jul;63(7):760-766.e1. doi: 10.1016/j.jclinepi.2009.09.009. Epub 2010 Jan 8.
PubMed 20056385
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Scale of Balance Recovery Confidence for Community-dwelling Older Adults
- ClinicalTrials.gov ID
- NCT04577365
- Acronym / sponsor ID
- REP0220
- Conditions
- Fall, Self Efficacy
- Keywords
- Accidental Falls, patient outcome assessment, postural balance, self-efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Collaborators
- Singapore Institute of Technology
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Oct 2020 (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.
Introduction: Patient-reported outcome measures (PROMs) provide clinicians with a greater understanding of patients' perceived ability in their physical performance. Existing PROMs on falls efficacy provide meaningful information about the perceived ability in older people to perform common activities of daily living without falling. However, the perceived ability to recover the balance from a slip, a trip, or volitional movements has been inadequately assessed. Balance recovery confidence relates to the judgement of self-reactive ability. The scale of balance recovery confidence (BRC) is a new PROM that measures perceived balance recovery self-efficacy. The purpose of the study protocol is to describe the first psychometric evaluation of BRC's measurement properties.
Methods and analysis: This study is a validation phase of a newly developed PROM conducted in Singapore. Two hundred community-dwelling older adults, aged 65 years and older, will complete five self-reported instruments (BRC), Activities-specific Balance Confidence Scale (ABC), Falls Efficacy Scale-International (FES-I), Late-Life Function and Disability Instrument-Function (LLDI-F) and Global Perceived Effect (GPE) and three performance measures (Hand strength dynamometer, 30-second Chair Stand, Mini BESTest). Classical test theory methods will assess acceptability, data completeness, targeting of the items, scaling assumptions, internal consistency reliability and construct validity. Factor analysis will establish unidimensionality. Rasch analysis will evaluate item fit, differential item functioning, response scale ordering, targeting of persons and items and the reliability.
Detailed description
Introduction: This study aims to conduct the first evaluation of measurement properties in the scale of balance recovery confidence. There are several measurement properties such as unidimensionality, validity (to what extent does the instrument measure the construct it purports to measure) and reliability (the degree to which measurement is free from error) of the PROM that is needed to be studied.
This psychometric validation aims to provide evidence that the PROM can be purposefully used in practice, given that rigorous methods have been applied for the development and validation of the BRC. For the study, balance recovery confidence is defined as the perceived ability to recover one's balance from perturbations, such as a slip, a trip, or a loss of balance that can occur in common, everyday activities. This focus will leave little ambiguity about precisely what is being measured. The resulting questionnaire is intended to be approximately 20 questions and should not take longer than 10 min to complete. The instrument is not intended to be used as a diagnostic tool of impaired specific balance recovery mechanisms. The BRC allows clinicians and researchers to quantifiably determine the balance recovery confidence in older adults and use the scale as a conduit for understanding older people's perspectives when encountering different perturbations during their daily activities.
The objectives are to:
- To evaluate the measurement properties of the BRC, i.e. acceptability, targeting, scaling assumptions and reliability using Classical Test Theory (CTT), the internal scale structure using Rasch measurement theory in the Singapore community-dwelling older adults.
- To assess the construct validity of the refined BRC against commonly used PROMs and performance measures in the Singapore community-dwelling older adults.
- To refine the items, response categories, and scale structure of the BRC using Rasch measurement theory in an English-speaking sample of community-dwelling older adults in Singapore.
Methods: Participants will attend two sessions in the study. In the first session, the researcher will use a measurement data form to record the participants' results of four questionnaires: BRC, ABC, FES-I, LLFDI-F and three performance measures: Jamar hand strength dynamometer, 30-second chair stand test and Mini BESTest. After seven days, participants will attend the second session to complete the BRC, and the GPE scale which will be used to ensure participants' perception of their abilities remained unchanged during the seven days. The time interval of 7-day had been reported to be sufficient to minimise recall bias. Participants will be asked if they have had experienced a fall, near-fall, or encountered any incident that might affect their balance recovery ability over the past seven days.
Statistical analysis: Quantitative data will be analysed and interpreted through two measurement test theories using IBM SPSS Statistic V.26.0 and Winsteps V.4.5.0. Classical test theory is a traditional quantitative approach to test the validity and reliability of a scale based on its items. This approach is based on the assumption that every observed score is a function of an individual's true score and random error. In contrast, RA works on the probability of a person's level on an item is a function of the person's ability and of the difficulty of the item. RA evaluates a scale against a mathematical measurement model and analyses the scale at the level of each item, and each person. Measurement properties including unidimensionality, internal structure, validity and reliability will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community sample
Key inclusion criteria (4 listed)
- 65-years and older,
- Living in the community,
- Functionally independent with or without the use of a walking aid and be able to read,
- Write and communicate in English.
Key exclusion criteria (3 listed)
- Require any physical assistance from another person to walk within the home,
- Presenting with clinical observable severe cognitive impairment.
- Unable to provide written consent to participate in the study
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
Scale of Balance Recovery Confidence
Time frame: 5 minutes
The scale of balance recovery confidence measures the perceived balance recovery self-efficacy in community-dwelling older adults. A response option ranged from 0 to 10 is listed with 10 indicating "Highly certain can do" and 0 refers to "Cannot do at all". The outcome measure is administered on Day 1 and Day 7.
Activities-specific Balance Confidence Scale
Time frame: 5 minutes
The Activities-specific Balance Confidence scale assesses older adults' confidence that they will not fall or lose their balance when performing several progressively challenging balance and mobility tasks. The response option ranged from 0% (no confidence) to 100% (complete confidence). The outcome measure is administered on Day 1
Falls Efficacy Scale - International
Time frame: 5 minutes
The Falls Efficacy Scale- International measures fear of falling or "concerns about falling" relating to basic and more demanding activities both physical and social. The response option ranged from 1-4 depicted by 1 for being not at all concerned, 2 for being somewhat concerned, 3 for being fairly concerned and 4 for being very concerned. The outcome measure is administered on Day 1
Late-Life Function and Disability Instrument-Function component
Time frame: 5 minutes
The Late-Life Function and Disability Instrument-Functional component of the instrument evaluates self-reported difficulty a person has in performing activities of daily living tasks. Factors that may influence the difficulty in task performance include pain, fatigue, fear, weakness, soreness, ailment, health conditions, and disabilities.There are 32 items with response options of "none," "a little," "some," "quite a lot," and "cannot do." An additional eight items will be completed by those who use canes or walkers. The outcome measure is administered on Day 1
3 secondary outcomes
Jamar hand strength dynamometer
Time frame: 10 minutes
30-second chair stand test
Time frame: 10 minutes
Mini BESTest
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Background: PubMed 31989948Tokur D, Grimmer M, Seyfarth A. Review of balance recovery in response to external perturbations during daily activities. Hum Mov Sci. 2020 Feb;69:102546. doi: 10.1016/j.humov.2019.102546. Epub 2019 Dec 31.
- Background: PubMed 2229948Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239.
- Background: PubMed 7814786Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
- Background: PubMed 19627691Simpson JM, Worsfold C, Fisher KD, Valentine JD. The CONFbal scale: a measure of balance confidence--a key outcome of rehabilitation. Physiotherapy. 2009 Jun;95(2):103-9. doi: 10.1016/j.physio.2008.12.004. Epub 2009 Mar 24.
- Background: PubMed 19329772Horak FB, Wrisley DM, Frank J. The Balance Evaluation Systems Test (BESTest) to differentiate balance deficits. Phys Ther. 2009 May;89(5):484-98. doi: 10.2522/ptj.20080071. Epub 2009 Mar 27.
- Background: PubMed 11909885Jette AM, Haley SM, Coster WJ, Kooyoomjian JT, Levenson S, Heeren T, Ashba J. Late life function and disability instrument: I. Development and evaluation of the disability component. J Gerontol A Biol Sci Med Sci. 2002 Apr;57(4):M209-16. doi: 10.1093/gerona/57.4.m209.
- Background: PubMed 20056385Kamper SJ, Ostelo RW, Knol DL, Maher CG, de Vet HC, Hancock MJ. Global Perceived Effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status. J Clin Epidemiol. 2010 Jul;63(7):760-766.e1. doi: 10.1016/j.jclinepi.2009.09.009. Epub 2010 Jan 8.
- Individual participant dataSharing planned: Yes. The study protocol will be shared
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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.
Shawn Soh principal investigator
Singapore Institute of Technology
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 Fall and Self Efficacy, run by Queen Margaret University at 1 site in Singapore.
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 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: status not confirmed, as of the sponsor's last update on 11 Nov 2021. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shawn Soh (96997689, ssoh@qmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale of Balance Recovery Confidence (time frame: 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04577365, which also lists 7 linked publications.
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 11 Nov 2021.