- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05373160
Reference Values of Different Functional Tests With or Without Cognitive Dual-task in Young Adults
September 12, 2022 updated by: Cigdem Emirza, Istanbul Bilgi University
Determination of Age- and Gender-specific Reference Values of Different Functional Tests With or Without Cognitive Dual-task in Young Adults
In this study, reference values for the five basic functional tests that are commonly used, with and without the addition of dual-task activity, will be determined.
It will be ensured that healthy normative data that researchers and clinicians can compare in determining the effects in different pathologies by using easy-to-perform evaluations.
The aim of this study is to determine the reference values performed with and without dual-task of the five functional tests for young adults according to age and gender by considering the interaction between both mobility and cognitive tasks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
107
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34500
- Istanbul University-Cerrahpasa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy young people
Description
Inclusion Criteria:
- 18-35 years
- Individuals who were not diagnosed with musculoskeletal disorder
- Volunteers
Exclusion Criteria:
- Using an assistive device for walking
- Having cognitive problems
- Individuals who had undergone lower extremity surgery due to musculoskeletal problems in the last six months
- Body mass index greater than 30 kg/m2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy young group
Individuals who are 18-35 years, did not diagnosed with musculoskeletal disorder, and volunteers
|
Assessment of functional tests with and without dual tasks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed Up and Go Test without dual task
Time Frame: Baseline
|
The test measures the time (in seconds) will taken by a participant to stand up from a chair, walk a distance of 3 m, turn, walk back to the chair, and sit down.
To perform the test, the participants will sit on a chair, placing his/her back against the backrest and resting his/her arms on armrests.
On the instruction "Go", the participants will rise up from a chair, walk to a line/block on the floor 3 m away, turn around, return, and sit back on a chair.
|
Baseline
|
4 Meter Gait Speed Test without dual task
Time Frame: Baseline
|
The participant will walk briskly through the 1-meter "test" zone for acceleration, the central 4-meter "test" zone, and the 1-meter deceleration zone.
Time starts with the first leg after the 0 meter line and time is stopped with the first leg after the 4 meter line.
In this test, the result is recorded in meters per second (m/s).
|
Baseline
|
10 Meter Walk Test without dual task
Time Frame: Baseline
|
In this test, the participant will walk at the best possible speed in a pre-measured 10-meter area.
The time starts when the participant's foot is on the starting line and ends when they cross the finish line.
In this test, the result is recorded in total seconds.
|
Baseline
|
Timed 25-Foot Walk Test without dual task
Time Frame: Baseline
|
The participant walks the distance of 7.62 meters as fast as possible but without running.
The time to complete the distance will recorded in seconds.
|
Baseline
|
1 min-Sit-to-Stand Test without dual task
Time Frame: Baseline
|
Participants put their hands on their hips and they had to stand up and sit down completely and as many times as possible from a chair (height = 46 cm) without arm rests during one minute.
Participants are not allowed to use their arms as support.
The number of sit-ups performed during 1 minute will recorded.
|
Baseline
|
Timed Up and Go Test with dual task
Time Frame: Baseline
|
The test measures the time (in seconds) will taken by a participant to stand up from a chair, walk a distance of 3 m, turn, walk back to the chair, and sit down.
To perform the test, the participants will sit on a chair, placing his/her back against the backrest and resting his/her arms on armrests.
On the instruction "Go", the participants will rise up from a chair, walk to a line/block on the floor 3 m away, turn around, return, and sit back on a chair.
The participants will perform with dual task.
This dual task will be to say the names of animals.
|
Baseline
|
4 Meter Gait Speed Test with dual task
Time Frame: Baseline
|
The participant will walk briskly through the 1-meter "test" zone for acceleration, the central 4-meter "test" zone, and the 1-meter deceleration zone.
Time starts with the first leg after the 0 meter line and time is stopped with the first leg after the 4 meter line.
In this test, the result is recorded in meters per second (m/s).
The participants will perform with dual task.
This dual task will be counting down the months of the year starting from December.
|
Baseline
|
10 Meter Walk Test with dual task
Time Frame: Baseline
|
In this test, the participant will walk at the best possible speed in a pre-measured 10-meter area.
The time starts when the participant's foot is on the starting line and ends when they cross the finish line.
In this test, the result is recorded in total seconds.
The participants will perform with dual task.
This dual task will be counting numbers back from 100 by threes.
|
Baseline
|
Timed 25-Foot Walk Test with dual task
Time Frame: Baseline
|
The participant walks the distance of 7.62 meters as fast as possible but without running.
The time to complete the distance will recorded in seconds.
The participants will perform with dual task.
This dual task will be counting numbers back from 100 by sevens.
|
Baseline
|
1 min-Sit-to-Stand Test with dual task
Time Frame: Baseline
|
Participants put their hands on their hips and they had to stand up and sit down completely and as many times as possible from a chair (height = 46 cm) without arm rests during one minute.
Participants are not allowed to use their arms as support.
The number of sit-ups performed during 1 minute will recorded.
The participants will perform with dual task.
This dual task will be counting city names.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Yildiz Analay Akbaba, PT, phD, Istanbul University - Cerrahpasa (IUC)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 25, 2022
Primary Completion (ACTUAL)
August 25, 2022
Study Completion (ACTUAL)
August 30, 2022
Study Registration Dates
First Submitted
May 10, 2022
First Submitted That Met QC Criteria
May 10, 2022
First Posted (ACTUAL)
May 13, 2022
Study Record Updates
Last Update Posted (ACTUAL)
September 13, 2022
Last Update Submitted That Met QC Criteria
September 12, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- qH25cGJv
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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