- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07258355
Occupation-Based Multicomponent Intervention to Reduce Fall Risk in Older Adults
Occupation-Based Multicomponent Intervention to Reduce Fall Risk in Older Adults Living in a Community With a History of Falls: A Prospective Quasi-Experimental Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Hacettepe Universitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
History of at least one fall within the last 6 months
Age 65 years or older
Exclusion Criteria
Presence of a primary neurological condition that could contribute to falls (e.g., stroke, Parkinson's disease)
Presence of an orthopedic condition that could contribute to falls (e.g., extremity fractures, osteoarthritis, limb length discrepancy)
Presence of a psychiatric condition that could contribute to falls
History of any surgical operation involving the extremities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Occupation-Based Multi-Component Intervention
|
Occupation-Based Multi-Component Intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini Mental State Examination
Time Frame: 12 week
|
It is one of the most widely used cognitive screening tools.
It consists of five main sections-orientation, immediate recall, attention and calculation, delayed recall, and language-covering a total of 11 items.
Scores range from 0 to 30, with higher scores indicating better cognitive functioning.
The Turkish validity and reliability study has been conducted, and a cut-off score of 23/24 is commonly recommended for the Turkish population.
|
12 week
|
|
Canada Occupational Performance Measurement
Time Frame: 12 week
|
It will be used to identify the daily occupations that older adults want to do, need to do, or are expected to do, as well as to determine which of these occupations are affected by current difficulties.
The COPM allows individuals to identify activities within the categories of self-care, leisure, and productivity.
From these, five priority activities are selected, and the individual rates both their occupational performance and satisfaction for each activity on a scale from 1 to 10. Higher scores indicate better performance and greater satisfaction.
The scores for performance and satisfaction are summed and divided by the number of selected activities to obtain mean performance and satisfaction scores.
|
12 week
|
|
Tinetti Balance and Gait Test
Time Frame: 12 week
|
The Tinetti scale evaluates an individual's balance and gait abilities through two components: balance (9 items) and gait (7 items), each reflecting movements commonly performed during daily activities.
Each item is scored from 0 to 2, where 2 indicates correct and safe performance, 1 indicates performance with adaptations, and 0 indicates inability to perform the movement.
The balance items generate a balance score, the gait items generate a gait score, and their sum constitutes the total score, which indicates fall risk.
A total score of 18 or below reflects a high fall risk, 19-24 indicates a moderate risk, and 25 or above indicates a low fall risk.
The scale is widely used and considered valid and reliable for older adults.
|
12 week
|
|
Timed Up and Go test
Time Frame: 12 week
|
The TUG test assesses dynamic balance, fall risk, and functional mobility in older adults. During the test, the individual is asked to stand up from a chair, walk a distance of three meters, turn around, walk back to the chair, and sit down. The total time to complete the sequence is recorded as the test result. A duration longer than 12 seconds indicates decreased functional performance during daily activities and a higher risk of falling. The test is simple, quick to administer, and widely used in geriatric assessments. |
12 week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- James SL, Lucchesi LR, Bisignano C, Castle CD, Dingels ZV, Fox JT, Hamilton EB, Henry NJ, Krohn KJ, Liu Z, McCracken D, Nixon MR, Roberts NLS, Sylte DO, Adsuar JC, Arora A, Briggs AM, Collado-Mateo D, Cooper C, Dandona L, Dandona R, Ellingsen CL, Fereshtehnejad SM, Gill TK, Haagsma JA, Hendrie D, Jurisson M, Kumar GA, Lopez AD, Miazgowski T, Miller TR, Mini GK, Mirrakhimov EM, Mohamadi E, Olivares PR, Rahim F, Riera LS, Villafaina S, Yano Y, Hay SI, Lim SS, Mokdad AH, Naghavi M, Murray CJL. The global burden of falls: global, regional and national estimates of morbidity and mortality from the Global Burden of Disease Study 2017. Inj Prev. 2020 Oct;26(Supp 1):i3-i11. doi: 10.1136/injuryprev-2019-043286. Epub 2020 Jan 15.
- Altuntas O, Degerli MNO, Temizkan E, Ekici G. Psychometric properties of the Canadian occupational performance measure in older individuals. Turk J Med Sci. 2023 Nov 28;54(1):338-347. doi: 10.55730/1300-0144.5796. eCollection 2024.
- Leland NE, Elliott SJ, O'Malley L, Murphy SL. Occupational therapy in fall prevention: current evidence and future directions. Am J Occup Ther. 2012 Mar-Apr;66(2):149-60. doi: 10.5014/ajot.2012.002733.
- Kim M, Shin E, Kim S, Sok S. The Effectiveness of Multicomponent Intervention on Daily Functioning among the Community-Dwelling Elderly: A Systematic Review. Int J Environ Res Public Health. 2022 Jun 18;19(12):7483. doi: 10.3390/ijerph19127483.
- Gillespie LD, Gillespie WJ, Robertson MC, Lamb SE, Cumming RG, Rowe BH. Interventions for preventing falls in elderly people. Cochrane Database Syst Rev. 2001;(3):CD000340. doi: 10.1002/14651858.CD000340.
- Fernandez-Arguelles EL, Rodriguez-Mansilla J, Antunez LE, Garrido-Ardila EM, Munoz RP. Effects of dancing on the risk of falling related factors of healthy older adults: a systematic review. Arch Gerontol Geriatr. 2015 Jan-Feb;60(1):1-8. doi: 10.1016/j.archger.2014.10.003. Epub 2014 Nov 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 4fba1e62c6f1465b
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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