- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04087551
Development of the Balance Recovery Falls-Efficacy Scale for the Community-dwelling Older Adults
Incidence of Near-falls and the Development of the Balance Recovery Falls-efficacy Scale (BRFES) for the Community-dwelling Older Adults.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Singapore, Singapore, 138683
- Singapore Institute of Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Developing the list of items for BRFES
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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of near-falls
Time Frame: 6 months
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To determine the incidence of near-falls
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6 months
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Development of the Balance Recovery Falls-Efficacy Scale (BRFES)
Time Frame: 9 months
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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
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REP 0197
- 2019129 (OTHER: Singapore Institute of Technology)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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