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临床试验/NCT04577365
NCT04577365Unknown不适用

Validation of a New Scale of Balance Recovery Confidence for Community-dwelling Older Adults

Queen Margaret University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年2月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Activities-specific Balance Confidence Scale

研究概览

简要总结

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.

详细描述

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:

  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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Activities-specific Balance Confidence Scale

时间窗: 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

时间窗: 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

Scale of Balance Recovery Confidence

时间窗: 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.

Late-Life Function and Disability Instrument-Function component

时间窗: 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

次要结局

  • Mini BESTest(10 minutes)
  • 30-second chair stand test(10 minutes)
  • Jamar hand strength dynamometer(10 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shawn Leng-Hsien Soh

Principal Investigator

Queen Margaret University

研究点 (1)

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