NCT05373160

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

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

May 10, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 25, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

1 month

First QC Date

May 10, 2022

Last Update Submit

September 12, 2022

Conditions

Keywords

dual-taskfunctional testhealthy youngreference value

Outcome Measures

Primary Outcomes (10)

  • Timed Up and Go Test without dual task

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

Study Arms (1)

Healthy young group

Individuals who are 18-35 years, did not diagnosed with musculoskeletal disorder, and volunteers

Other: Assessment study

Interventions

Assessment of functional tests with and without dual tasks

Healthy young group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy young people

You may qualify if:

  • years
  • Individuals who were not diagnosed with musculoskeletal disorder
  • Volunteers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34500, Turkey (Türkiye)

Location

Related Publications (1)

  • Ahman HB, Berglund L, Cedervall Y, Giedraitis V, McKee KJ, Rosendahl E, Aberg AC. Timed "Up & Go" Dual-Task Tests: Age- and Sex-Specific Reference Values and Test-Retest Reliability in Cognitively Healthy Controls. Phys Ther. 2021 Oct 1;101(10):pzab179. doi: 10.1093/ptj/pzab179.

    PMID: 34272869BACKGROUND

MeSH Terms

Interventions

Outcome Assessment, Health Care

Intervention Hierarchy (Ancestors)

Outcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Study Officials

  • Yildiz Analay Akbaba, PT, phD

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 10, 2022

First Posted

May 13, 2022

Study Start

July 25, 2022

Primary Completion

August 25, 2022

Study Completion

August 30, 2022

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations