NCT07258355

Brief Summary

This study aims to examine the effects of an occupation-based, multicomponent occupational therapy intervention on older adults aged 65 years and above with a history of falls living in the community. The intervention consists of 12 individualized sessions designed around the participants' meaningful occupations. It incorporates balance and gait training, environmental modifications, behavioral strategies, and safety-enhancing activities within a holistic framework. The sample will include 40 older adults who have experienced at least one fall in the past year. Data will be collected using the Canadian Occupational Performance Measure (COPM), Tinetti Balance and Gait Test, Timed Up and Go Test (TUG), and Mini-Mental State Examination (MMSE). Pre- and post-intervention measurements will be compared to evaluate the program's effects on occupational performance, satisfaction, balance, and gait functions. The study is expected to provide valuable evidence on the effectiveness of occupation-based approaches in fall prevention interventions for older adults.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

December 12, 2025

Status Verified

November 1, 2025

Enrollment Period

29 days

First QC Date

November 19, 2025

Last Update Submit

December 5, 2025

Conditions

Keywords

Occupational therapyFall preventionOlder adultsOccupation-based interventionBalance and gait

Outcome Measures

Primary Outcomes (4)

  • Mini Mental State Examination

    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

    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

    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

    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

Study Arms (1)

Occupation-Based Multi-Component Intervention

EXPERIMENTAL
Behavioral: Occupation-Based Multi-Component Intervention

Interventions

Occupation-Based Multi-Component Intervention

Occupation-Based Multi-Component Intervention

Eligibility Criteria

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

You may qualify if:

  • History of at least one fall within the last 6 months
  • Age 65 years or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe Universitesi

Ankara, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

  • 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.

  • Gillespie LD, Gillespie WJ, Robertson MC, Lamb SE, Cumming RG, Rowe BH. Interventions for preventing falls in elderly people. Cochrane Database Syst Rev. 2003;(4):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.

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, Occupational Therapist, PhD Candidate

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 2, 2025

Study Start

November 1, 2025

Primary Completion

November 30, 2025

Study Completion

March 30, 2026

Last Updated

December 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations