Validation of a New Scale of Balance Recovery Confidence for Community-dwelling Older Adults
NCT ID: NCT04577365
Last Updated: 2021-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
200 participants
OBSERVATIONAL
2021-02-22
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
1. 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.
2. To assess the construct validity of the refined BRC against commonly used PROMs and performance measures in the Singapore community-dwelling older adults.
3. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* Presenting with clinical observable severe cognitive impairment.
* Unable to provide written consent to participate in the study
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Singapore Institute of Technology
OTHER
Queen Margaret University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Shawn Leng-Hsien Soh
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shawn Soh
Role: PRINCIPAL_INVESTIGATOR
Singapore Institute of Technology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Singapore Institute of Technology
Singapore, , Singapore
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Shawn Soh
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Tinetti 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.
Powell 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.
Simpson 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.
Horak 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.
Jette 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.
Kamper 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REP0220
Identifier Type: -
Identifier Source: org_study_id