NCT06307769

Brief Summary

Balance and fall problems are one of the most common geriatric syndromes in the elderly. Falls are one of the leading factors causing mortality in the elderly. One-third of individuals aged sixty-five and over fall once or more every year. When the causes of death in elderly individuals are examined; Accidents come in fifth place, and 2/3 of these accidents occur due to falls. The frequency of falls increases with age in 22% of individuals between the ages of 65-69. This rate is stated as 31% between the ages of seventy-five and seventy-nine, and 40% between the ages of 80-84. Geriatric individuals may be at risk of falling in different situations, often inside and outside the home. Falls generally occur more frequently in indoor areas such as bathrooms, kitchens and bedrooms. In these areas, falls caused by potentially dangerous factors such as slippery floors, carpet edges, and high thresholds are more common. A frequent fall occurs when jumping over an obstacle. Factors such as poor balance, vision problems or reduced muscle strength when overcoming obstacles can increase the risk of falling in this situation. The ability of geriatric individuals to overcome obstacles during daily activities is an important factor determining quality of life. Climbing stairs or crossing high thresholds is an important part of daily living activities and poses a risk of falling. Therefore, determining the stair height threshold and assessing obstacle crossing skills should be considered effective measures. When the literature is examined, clinicians generally prefer simpler functional tests because assessments involving disabilities take a long time to be administered, involve some equipment, and also require training to perform the assessment. In the literature, there is currently a version of the functional tests that is applied only by adding obstacles to the timed get up and go test. Thanks to this test, the ability of geriatric individuals to overcome obstacles can be evaluated and people can be trained with this test. For this reason, we wanted to determine the suitability of the 10-meter walking test, which is frequently used in geriatric individuals, when applied with the addition of an obstacle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 5, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 5, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2024

Completed
Last Updated

June 11, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 5, 2024

Last Update Submit

June 9, 2024

Conditions

Keywords

Geriatric Individuals, Balance, Assessment

Outcome Measures

Primary Outcomes (1)

  • Ten Meter Walk Test

    It is a test used to evaluate walking speed. Participants are instructed to walk at a normal walking pace before starting the test (if they use a device for walking support, they are allowed to walk with it). The clock starts when the participant's foot crosses the line at the beginning of the 10-meter course and stops when it crosses the line at the end of the course. Two measurements are made and the average walking speed is calculated in meters per second (m/s) (1). During the test, the test will also be performed with disabilities by adding 5 and 17 cm obstacles in addition to the original test. In this way, the use of the test applied by adding 5 and 17 cm obstacles will be evaluated in geriatric individuals.

    two day

Secondary Outcomes (3)

  • Berg Balance Scale

    two day

  • Functional Reach Test

    two day

  • Timed up and go test

    two day

Study Arms (2)

Geriatric Group

balance assessment

Control Group

balance assessment

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study will consist of 2 groups. The first group is geriatric individuals over the age of 65, and the second group is young healthy adults between the ages of 30-65.

You may qualify if:

  • Individuals aged 65 and over,
  • For the young adult group, individuals between the ages of 30-65
  • Individuals who volunteer to participate in the research,
  • Individuals without any neurological disease,
  • Individuals who do not have cooperation and communication problems

You may not qualify if:

  • Those with neurological problems (patients diagnosed with Alzheimer's, Parkinson's, Dementia, MS)
  • Those with perceptual problems
  • Individuals with cooperation and communication problems will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Related Publications (1)

  • Onal B, Kocaman AA. The validity and reliability of the 10-meter walk test with obstacles in community-dwelling older adults. Int J Rehabil Res. 2025 Jun 1;48(2):120-125. doi: 10.1097/MRR.0000000000000665. Epub 2025 Apr 28.

Study Officials

  • Birol Önal, Dr

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 13, 2024

Study Start

March 5, 2024

Primary Completion

May 15, 2024

Study Completion

May 25, 2024

Last Updated

June 11, 2024

Record last verified: 2024-03

Locations