NCT04577365

Brief 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 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.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 11, 2021

Status Verified

November 1, 2021

Enrollment Period

1.6 years

First QC Date

September 30, 2020

Last Update Submit

November 9, 2021

Conditions

Keywords

Accidental Fallspatient outcome assessmentpostural balanceself-efficacy

Outcome Measures

Primary Outcomes (4)

  • 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.

    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

    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

    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

    5 minutes

Secondary Outcomes (3)

  • Jamar hand strength dynamometer

    10 minutes

  • 30-second chair stand test

    10 minutes

  • Mini BESTest

    10 minutes

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore Institute of Technology

Singapore, 138683, Singapore

RECRUITING

Related Publications (7)

  • 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.

    PMID: 31989948BACKGROUND
  • 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.

    PMID: 2229948BACKGROUND
  • 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.

    PMID: 7814786BACKGROUND
  • 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.

    PMID: 19627691BACKGROUND
  • 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.

    PMID: 19329772BACKGROUND
  • 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.

    PMID: 11909885BACKGROUND
  • 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.

    PMID: 20056385BACKGROUND

Study Officials

  • Shawn Soh

    Singapore Institute of Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shawn Soh

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 6, 2020

Study Start

February 22, 2021

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

November 11, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

The study protocol will be shared

Shared Documents
STUDY PROTOCOL
Time Frame
The study protocol will be made available after publication
Access Criteria
\- PROM developers

Locations