Development of the Balance Recovery Falls-Efficacy Scale for the Community-dwelling Older Adults

Aging Clinical Trial

Official title:

Incidence of Near-falls and the Development of the Balance Recovery Falls-efficacy Scale (BRFES) for the Community-dwelling Older Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087551
• Other study ID #: REP 0197
• Secondary ID: 2019129
• Status: Completed
• Phase: N/A
• Start date: September 11, 2019
• Est. completion date: September 15, 2020

Study information

• Verified date: September 2020
• Source: Queen Margaret University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will progress through two phases

The first phase will recruit 30 older adults from ages of 65 and older living in the community. A study administrator will contact the participants daily over a 21-day period to obtain frequency and type of event experienced e.g. no fall, fall, near fall (hand), near-fall (leg) or near-fall (other). No other details of the event will be ascertained because this preliminary study will be to determine the incidence of near-falls in a sample of community-dwelling seniors.

The second phase will be to develop a scale which operationalize balance recovery confidence in community-dwelling older adults. In the first stage of the study, twelve older adults will be recruited to develop a comprehensive list of relevant items for the scale. Purposive sampling will be used to invite participants from the earlier study. This approach will ensure sample representativeness of the population and to include participants who have had demonstrated an understanding of near-falls and balance recovery maneuvres in the previous study to develop the scale. An exhaustive list of scale items will be generated from two focus group formed by six participants using a nominal group technique. This consensus-based technique ensures that all items in the scale are relevant and comprehensible to the community-dwelling older adults to discriminate the confidence level in one's ability to perform balance recovery maneuvres. The scale will then be sent to a panel of 50 experts including healthcare professionals as well as a new group of community-dwelling older adults to determine the appropriateness of items ensuring that the scale is relevant, comprehensive and comprehensible. Delphi technique will be adopted as the method to obtain a consensus among experts to finalize the Balance Recovery Falls-Efficacy Scale (BRFES).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 65-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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Accidental Fall
• Aging
• Self Efficacy

Intervention

Other:
• Developing the list of items for BRFES
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.

Locations

Country	Name	City	State
Singapore	Singapore Institute of Technology	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Queen Margaret University	Singapore Institute of Technology

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of near-falls	To determine the incidence of near-falls	6 months
Primary	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