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NCT Number: NCT06961799

Validating a Multifactorial Algorithm to Predict Fall Risk in Community Dwelling Older Persons Aged 65 Years or Older

Falls in older adults have an annual incidence between 23 and 34% for persons of 65 years and older. The lack of transfer of promising research results on falls prevention to daily practice may have several explanations. One of the first concerns for that matter may be a valid and sensitive selection of the persons at risk who are eligible for fall prevention interventions

Goals of the prospective obeservational study:

1. To validate a new, comprehensive, multifactorial screeningsintrument to predict the risk on falls in community dwelling, Belgian, older adults (>65years or older). 2. To optimize the new, comprehensive, multifactorial screeningsintrument and to specify correct cut off scores

Researchers will compare the data of the accuracy of new algorithm with the current Belgian policy.

Participants will participate in a one-time testing moment, where they will be asked some questions about general characteristics and medical history, followed by two questionnaire and seven physical tests . Based on this data, their fall risk will be assessed. In the year that follows, the older person's fall behavior will be monitored with a monthly falls calender. Participant will be asked to fill out these calenders everyday ('Did you fall today?' YES/NO) and send them at the end of each month to the researchers, digitally or postal.

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Key information

Conditions

Aged 65 Years or Older Community Dwelling Older Adults Falls (Accidents) in Old Age Falls Risk

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University

Ghent, Belgium, 9000

Location status: Recruiting

About this study

Two questionnaires:

  • Geriatric Depression Scale - 16
  • Falls Efficacy Scale - International

Seven physical tests:

  • Timed Up and Go
  • Times Up and Go with cognitive dual task (100 (repeatedly) minus 3)
  • Single Limb Stance
  • 5x Sit to Stand
  • 4meter Gait Speed
  • Tinetti
  • Four Balance Test

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 65years or older
  • community dwellers
  • absence of surgery or exacerbation of symptoms in the last 6 months
  • ability to stand and walk independently (alone), possibly with an walking aid.

Exclusion criteria

  • <65 years of age
  • surgery within the previous 6 months affecting gait and mobility
  • exacerbation of symptoms coming from a diagnosed disease
  • older adults with insufficient (language) comprehension to complete the tests and questionnaires

Treatment and study plan

Multifactorial algorithm to predict fall risk

Diagnostic Test

In this new multifactorial algorithm we will add baseline data (personal characteristics, medical history, and physical and psychological measurements) to predict an older adults risk on falls. The accuracy of this new model will be tested with a 1-year follow up on falls.

The new algorithm is inspired by the study of Lusardi et al. (2017): Lusardi MM, Fritz S, Middleton A, Allison L, Wingood M, Phillips E, Criss M, Verma S, Osborne J, Chui KK. Determining Risk of Falls in Community Dwelling Older Adults: A Systematic Review and Meta-analysis Using Posttest Probability. J Geriatr Phys Ther. 2017 Jan/Mar;40(1):1-36. doi: 10.1519/JPT.0000000000000099. PMID: 27537070; PMCID: PMC5158094.

Primary outcomes

  1. Conducted analysis of integraded tests

    Time frame: Baseline

    Fall risk calculated with the new multifactorial algorithm based on:

    • general, personal characteristics
    • medical history
    • physical measurements
    • self reported questionnaires

  2. Number of falls among Belgian, community dwelling older adults

    Time frame: 1 year

    The number of falls measured with a monthly falls calender

Secondary outcomes

  1. Depression

    Time frame: Baseline

    Measured with the Geriatric Depression Scale (GDS-16)

  2. Fear of falling

    Time frame: Baseline

    Measured with the Falls Efficacy Scale (FES-I)

  3. Functional mobility

    Time frame: Baseline

    Measured with the Timed Up and Go (seconds)

  4. Executive cognitive capacity

    Time frame: Baseline

    Measured with the Timed Up and Go in combination with a cognitive dual task (100-3-3-3-...) (seconds)

  5. Static Balance

    Time frame: Baseline

    Measured with the Single Leg stance (seconds)

  6. Strength of the lower limbs

    Time frame: Baseline

    Measured with the 5x Sit to Stand (second)

  7. Gait speed

    Time frame: Baseline

    Measured with the 4m Gait Speed (m/s)

  8. Static and dynamic balance

    Time frame: Baseline

    Measured with the Tinetti: Performance-Oriented Mobility Assessment

  9. Static Balance

    Time frame: Baseline

    Measured with the 4 balance test

Study contacts

Contact information is provided by the study sponsor or research team.

Ellis Rommers, PhD

CONTACT

[email protected]

+32 9 332 46 57

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 8, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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