NCT04087551

Brief Summary

The first phase of the study aims to study the incidence of near-falls. The second phase will be to develop a scale which operationalize balance recovery confidence in the older adults. This study will determine the incidence of near-falls in a sample of community-dwelling older adults and will develop the Balance Recovery Falls-Efficacy scale (BRFES) for the community-dwelling older adults using the COSMIN method. This scale will be used to measure the confidence level of the community-dwelling older adults in their ability to execute balance recovery maneuvers in common, everyday functional activities to prevent a fall.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

September 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

September 11, 2019

Last Update Submit

September 14, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Incidence of near-falls

    To determine the incidence of near-falls

    6 months

  • Development of the Balance Recovery Falls-Efficacy Scale (BRFES)

    To develop and validate the Balance Recovery Falls-Efficacy Scale (BRFES). The construct measured is the confidence in one's ability to execute balance recovery manoeuvres in common, everyday functional activities to prevent a fall. The scale response option ranged from 1 to 10 with a higher score reflecting higher confidence. The scale would have 16 items indicating a total score range of 16 to 160. A higher total score value represent a better outcome.

    9 months

Study Arms (1)

Developing the list of items for BRFES

EXPERIMENTAL

Two groups of six community-dwelling older adults will participate in a focus group session. Each focus group session will begin with a trained facilitator using a session guide welcoming the participants and introducing the participants in the group. The session will adopt a nominal group method which includes silent generation of ideas, sharing of an idea in a 'round robin' fashion, group discussion to clarify ideas and then completing the session with anonymous voting to include items into a list of items to be included in the Balance Recovery Falls-Efficacy Scale (BRFES).

Other: Developing the list of items for BRFES

Interventions

The finalized list of items will be discussed by two researchers who will combine similar items generated by the two focus groups to complete the Balance Recovery Falls-Efficacy Scale. The list of items has been developed by a group of community-dwelling older adults who had demonstrated an understanding of near-falls and will be able to articulate the use of balance recovery strategies used in near-fall experiences.

Developing the list of items for BRFES

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • year-old and above
  • Ability to read, write and communicate in English
  • History of at least one near-fall or one fall within the last 12 months
  • Living independently in the community with or without the use of a walking aid
  • Not having any cognitive dysfunction by achieving a score of 7 or less in the 6-item cognitive impairment test (6CIT)
  • Able to walk 6 meters within 12 seconds by performing the Timed Up and Go (TUG) test
  • Able to catch a 30cm ruler by each hands using the ruler drop test

You may not qualify if:

  • Requiring any physical assistance from another person to walk within home
  • Known active malignant conditions
  • Cardiovascular conditions e.g. neurally mediated syncope, cardiac syncope, structural heart diseases e.g. aortic stenosis or hospitalization for myocardial infarction or heart surgery within 3 months
  • Pulmonary conditions e.g. serious chronic obstructive pulmonary disease or oxygen dependence
  • Musculoskeletal conditions e.g. moderate to severe osteoarthritis that could affect balance control and muscle function e.g. self-reported pain or dysfunction of the trunk and extremities, fractures or injuries in the extremities in the last 6 months
  • Neurological conditions such as Parkinson's Disease, sequelae of stroke, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS) or severe Dementia or epilepsy
  • Legal blindness, severe visual impairment, severe hearing impairment or legal deafness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore Institute of Technology

Singapore, 138683, Singapore

Location

Related Publications (1)

  • Soh SL, Tan CW, Lane J, Yeh TT, Soon B. Near-falls in Singapore community-dwelling older adults: a feasibility study. Pilot Feasibility Stud. 2021 Jan 12;7(1):25. doi: 10.1186/s40814-020-00748-1.

Study Officials

  • Shawn Soh

    Singapore Institute of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Phase 1 Participants will be requested to report the incidence of no fall, near-fall or a fall daily over the next 21-day period. There will be 3 options given to the participants: (1) a daily telephone call at a prearranged timing or (2) a daily text message given at a prearranged timing or both. A study administrator will contact the participant daily using the preferred mode of reporting. All information will be recorded in a logbook. Phase 2 The development of the Balance Recovery Falls-Efficacy scale will be guided using the COSMIN methodology. This development is based on inputs from the community-dwelling older adults to ensure relevance, comprehensiveness and comprehensibility. The scale would then be validated with a group of healthcare professionals and another new group of community-dwelling older adults using the Delphi method.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 12, 2019

Study Start

September 11, 2019

Primary Completion

September 15, 2020

Study Completion

September 15, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations