Effect of Sequencing on Outcome Measures

December 10, 2024 updated by: Louisiana State University Health Sciences Center Shreveport

Influence of Test Order of Isokinetic Torque, Y-Balance/Firefighter-Specific Functional-Balance, and Forward-Step-Down on Test Performance: Identifying Optimal Sequences

This pilot study will examine the effect of testing order on test outcomes for measures of strength, dynamic balance, and movement quality. Each participant will perform a baseline test, then will perform the 6 iterations of the testing sequence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study employs a Repeated Measures Design, with each participant tested multiple times in combinations of 1) the Isokinetic Torque Test, 2) the Y-Balance Test/Firefighter-Specific Functional-Balance Test, and 3) the Forward-Step-Down Test. The investigators will conduct a total of seven testing sessions, including a control session (informed consent, familiarization with outcome measures, and control data collection) and the following six different patterns: 1-2-3, 1-3-2, 2-1-3, 2-3-1, 3-1-2, and 3-2-1. The order of the sessions will be randomized and counterbalanced to prevent bias effects. The control session will be performed in the following order: (1) Forward-Step-Down Test, (2a) Firefighter Specific Functional Balance Test, (2b) Y-balance test, (3) isokinetic tests (hip then knee).

Participants will be asked to avoid exercise or vigorous physical activity for the 24 hours prior to any testing session to minimize the effects of non-test-related fatigue on the study outcomes. Pre and post-test fatigue will be measured with the Rating of Fatigue (ROF) Scale. Pre-and post-test exertion will be measured with the Borg Rating of Perceived Exertion (RPE) Scale (attached). Heartrate will be measured and recorded at each scale rating point.

Upon arrival for the control session, participants will have their height measured using a stadiometer and their weight recorded. This will be followed by the performance of the initial 1-2-3 pattern. The time needed for the participant to perform each test will be recorded and subsequent performances of that test will be carried out in this time frame.

For visits two through seven, participants will be weighed again upon arrival and perform one of the six patterns. Sessions two to seven will be separated by at least one day to minimize the influence of fatigue. Each session will include isokinetic torque measurements of the hip abductors and adductors, knee flexors and extensors, the Y-Balance Test, the Firefighter-Specific Functional-Balance Test, and the Forward-Step-Down Test. The dominant leg will be used for unilateral tests, as determined by the leg used to kick a ball. The order of outcome measures will be randomized for each participant to minimize the effects of fatigue and recovery.

Five minutes of warm-up on a stationary bike or walking will be performed to start each exercise session. Five minutes of rest and instruction will be provided between each outcome measure. Five minutes of rest will be given between isokinetic tests (hip abduction to adduction) to allow for machine set-up and instructions. One minute of rest will be given between each isokinetic speed, with three speeds tested for the hip (30°, 60°, and 120° per second) and knee (60°, 180°, and 300° per second) muscles.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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

  • United States
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • LSUHSC-Shreveport

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy adult by Physical Activity Readiness Questionnaire+ screening process

Exclusion Criteria:

  • lower extremity or spine injury in past 6 months
  • vestibular disorder
  • known pregnancy
  • inability to complete data collection

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control trial
Testing order: (1) forward step down test, (2) firefighter specific functional balance test & y-balance test, (3) hip isokinetic strength & knee isokinetic strength
Other: Control order
Participants will perform an initial baseline of tests, order of 1- 2- 3
Experimental: sequenced trials
Participants will perform the following variations on testing order over 6 separate sessions: 1-2-3, 1-3-2, 2-1-3, 2-3-1, 3-1-2, and 3-2-1
Other: Randomized sequence
the testing order will be randomized for follow up testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forward-Step-Down Test
Time Frame: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
a step-down task that is performed off a 20 cm box. Five repetitions are performed to give one score (minimum score 0, maximum score 6). A higher score is worse.
This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Firefighter Specific Functional Balance Test
Time Frame: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
A dynamic balance test performed by stepping down from a 15cm box, walking across a low beam (4cm high), and stepping up onto a 10cm box, turning around, and returning to the original box. 8 Trials are performed. In 4 trials, a bar is placed at 75% of the participant's height for them to negotiate while on the beam. A faster time with fewer errors is better.
This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Y-Balance Test
Time Frame: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
A dynamic balance test that is performed on the dominant leg, reaching in the anterior, posteromedial, and posterolateral directions. The length of reach is standardized to participants' leg length. A higher score is better.
This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Knee Extensor Isokinetic Test
Time Frame: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Knee extensor isokinetic strength will be tested at 60°, 180°, and 300° per second from the seated position with 5, 10, and 10 concentric contractions for each speed. A higher reading of strength is better.
This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Hip Abductor Isokinetic Test
Time Frame: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Hip abductor strength will be tested at 30°, 60°, and 120° per second from the standing position. A higher reading of strength is better.
This outcome will be assessed at each visit throughout the study, an average of 6 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rating of Fatigue
Time Frame: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
A score from 0-10 will be provided before and after each test category (strength, balance, movement quality). A higher score indicated more fatigue.
This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Rating of Perceived Exertion
Time Frame: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
A score from 6-20 will be provided before and after each test category (strength, balance, movement quality). A higher score indicated more perceived exertion.
This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Heartrate
Time Frame: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
heartrate will be recorded as a measure of physiological effort and for participant safety.
This outcome will be assessed at each visit throughout the study, an average of 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louisiana State University Health Sciences Center Shreveport

Investigators

  • Principal Investigator: Erin McCallister, DPT, LSUHSC-Shreveport

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.

General Publications

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 23, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

October 15, 2024

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 10, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002716

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

product manufactured in and exported from the U.S.

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.

Clinical Trials on Muscle Weakness

Clinical Trials on Control order

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe