GeriatricNCT07258355
Occupation-Based Multicomponent Intervention to Reduce Fall Risk in Older Adults
A study testing Occupation-Based Multi-Component Intervention in people with Geriatric and Fall, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- Occupation-Based Multi-Component Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- History of at least one fall within the last 6 months
- Age 65 years or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
This study aims to evaluate the effects of a 12-session occupation-based, multicomponent occupational therapy intervention for older adults aged 65 years and above who have a history of falls. Falls are common in this population and are influenced by a combination of physical, behavioral, and environmental factors. Occupational therapy interventions that integrate balance training, environmental modification, and activity-based strategies may support safer participation in daily occupations. The intervention in this study is individualized and structured around the meaningful occupations identified by participants through the Canadian Occupational Performance Measure (COPM). The program includes components such as balance and gait training during daily activities, safety education, environmental adaptations, and behavioral strategies to reduce fall risk. Sessions are conducted individually in a face-to-face format and include both clinic-based and real-environment activities. Participants will complete standardized assessments before and after the intervention, including measures of occupational performance, satisfaction, balance, and functional mobility. The results will contribute to the understanding of how occupation-based multicomponent interventions support fall prevention and functional independence in community-dwelling older adults.
- Conditions
- Geriatric, Fall, Cognition, Balance, Occupational Therapy
- Being tested
- Occupation-Based Multi-Component Intervention
- Keywords
- Occupational therapy, Fall prevention, Older adults, Occupation-based intervention, Balance and gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupation-Based Multi-Component InterventionBehavioural
Occupation-Based Multi-Component Intervention
| Study group | Role | What they receive |
|---|---|---|
| Occupation-Based Multi-Component Intervention | Experimental | Not described Receives: Behavioral: Occupation-Based Multi-Component Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Nov 2025
- Primary completion30 Nov 2025
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for GeriatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medine Nur Özata Değerli, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258355
- Sponsor's protocol ID
- 4fba1e62c6f1465b
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22394524Kim 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.
PubMed 35742730James 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.
PubMed 31941758Gillespie 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.
PubMed 11686957Fernandez-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.
PubMed 25456888Altuntas 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.
PubMed 38812638
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07258355
- Acronym / sponsor ID
- 4fba1e62c6f1465b
- Conditions
- Geriatric, Fall, Cognition, Balance, Occupational Therapy
- Keywords
- Occupational therapy, Fall prevention, Older adults, Occupation-based intervention, Balance and gait
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to evaluate the effects of a 12-session occupation-based, multicomponent occupational therapy intervention for older adults aged 65 years and above who have a history of falls. Falls are common in this population and are influenced by a combination of physical, behavioral, and environmental factors. Occupational therapy interventions that integrate balance training, environmental modification, and activity-based strategies may support safer participation in daily occupations. The intervention in this study is individualized and structured around the meaningful occupations identified by participants through the Canadian Occupational Performance Measure (COPM). The program includes components such as balance and gait training during daily activities, safety education, environmental adaptations, and behavioral strategies to reduce fall risk. Sessions are conducted individually in a face-to-face format and include both clinic-based and real-environment activities. Participants will complete standardized assessments before and after the intervention, including measures of occupational performance, satisfaction, balance, and functional mobility. The results will contribute to the understanding of how occupation-based multicomponent interventions support fall prevention and functional independence in community-dwelling older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occupation-Based Multi-Component Intervention | Experimental | Behavioral: Occupation-Based Multi-Component Intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- History of at least one fall within the last 6 months
- Age 65 years or older
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupation-Based Multi-Component InterventionOccupation-Based Multi-Component Intervention | Behavioural | Occupation-Based Multi-Component Intervention |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Results publication: PubMed 22394524Leland 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.
- Results publication: PubMed 35742730Kim 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.
- Results publication: PubMed 31941758James 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.
- Results publication: PubMed 11686957Gillespie 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.
- Results publication: PubMed 25456888Fernandez-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.
- Results publication: PubMed 38812638Altuntas 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.
- Individual participant dataSharing planned: No
Related trials for Geriatric
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
RecruitingPhase 1
A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures
Focal Seizures
RecruitingObservational study
Validation of the D-TAP Parental Questionnaire for Early Screening of Pediatric Feeding Disorder in Hospitalized Children Aged 8 to 18 Months
Pediatric Feeding Disorder, Feeding Difficulties in Infants and Young Children
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupation-Based Multi-Component Intervention in people with Geriatric and Fall, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Mental State Examination (time frame: 12 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07258355, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.