Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07258355

Occupation-Based Multicomponent Intervention to Reduce Fall Risk in Older Adults

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Geriatric Balance Cognition Fall Occupational Therapy

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe Universitesi

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Occupation-Based Multi-Component Intervention

Behavioral

Occupation-Based Multi-Component Intervention

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Dec 12, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.