Effect of Sequencing on Outcome Measures

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06445491
• Other study ID #: STUDY00002716
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Louisiana State University Health Sciences Center Shreveport
• Contact: Erin McCallister, DPT
• Phone: 3188133502
• Email: erin.mccallister[@]lsuhs.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 57 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness

Intervention

Other:
• Control order
Participants will perform an initial baseline of tests, order of 1- 2- 3
• Randomized sequence
the testing order will be randomized for follow up testing.

Locations

Country	Name	City	State
United States	LSUHSC-Shreveport	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center Shreveport

Country where clinical trial is conducted

United States, 

References & Publications (12)

Brent JL, Myer GD, Ford KR, Paterno MV, Hewett TE. The effect of sex and age on isokinetic hip-abduction torques. J Sport Rehabil. 2013 Feb;22(1):41-6. doi: 10.1123/jsr.22.1.41. Epub 2012 Jun 18. — View Citation

Claiborne TL, Timmons MK, Pincivero DM. Test-retest reliability of cardinal plane isokinetic hip torque and EMG. J Electromyogr Kinesiol. 2009 Oct;19(5):e345-52. doi: 10.1016/j.jelekin.2008.07.005. Epub 2008 Oct 8. — View Citation

Gagge AP, Stolwijk JA, Hardy JD. Comfort and thermal sensations and associated physiological responses at various ambient temperatures. Environ Res. 1967 Jun;1(1):1-20. doi: 10.1016/0013-9351(67)90002-3. No abstract available. — View Citation

Games KE, Winkelmann ZK, McGinnis KD, McAdam JS, Pascoe DD, Sefton JM. Functional Performance of Firefighters After Exposure to Environmental Conditions and Exercise. J Athl Train. 2020 Jan;55(1):71-79. doi: 10.4085/1062-6050-75-18. Epub 2019 Dec 26. — View Citation

Gokeler A, Welling W, Zaffagnini S, Seil R, Padua D. Development of a test battery to enhance safe return to sports after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):192-199. doi: 10.1007/s00167-016-4246-3. Epub 2016 Jul 16. — View Citation

Hewett TE, Ford KR, Hoogenboom BJ, Myer GD. Understanding and preventing acl injuries: current biomechanical and epidemiologic considerations - update 2010. N Am J Sports Phys Ther. 2010 Dec;5(4):234-51. — View Citation

Lopes TJA, Simic M, Myer GD, Ford KR, Hewett TE, Pappas E. The Effects of Injury Prevention Programs on the Biomechanics of Landing Tasks: A Systematic Review With Meta-analysis. Am J Sports Med. 2018 May;46(6):1492-1499. doi: 10.1177/0363546517716930. Epub 2017 Jul 31. — View Citation

McCallister, E., & Flowers, D. W. (2020). Can the Forward-Step-Down Test Be Used Reliably in the Clinical Setting to Assess Movement Changes Resulting from Maximal Exertion? A Pilot Study. Internet Journal of Allied Health Sciences and Practice, 18(4).

Nascimento LR, Teixeira-Salmela LF, Souza RB, Resende RA. Hip and Knee Strengthening Is More Effective Than Knee Strengthening Alone for Reducing Pain and Improving Activity in Individuals With Patellofemoral Pain: A Systematic Review With Meta-analysis. J Orthop Sports Phys Ther. 2018 Jan;48(1):19-31. doi: 10.2519/jospt.2018.7365. Epub 2017 Oct 15. — View Citation

Park KM, Cynn HS, Choung SD. Musculoskeletal predictors of movement quality for the forward step-down test in asymptomatic women. J Orthop Sports Phys Ther. 2013;43(7):504-10. doi: 10.2519/jospt.2013.4073. Epub 2013 Jun 11. — View Citation

Powers CM. The influence of abnormal hip mechanics on knee injury: a biomechanical perspective. J Orthop Sports Phys Ther. 2010 Feb;40(2):42-51. doi: 10.2519/jospt.2010.3337. — View Citation

van Melick N, Meddeler BM, Hoogeboom TJ, Nijhuis-van der Sanden MWG, van Cingel REH. How to determine leg dominance: The agreement between self-reported and observed performance in healthy adults. PLoS One. 2017 Dec 29;12(12):e0189876. doi: 10.1371/journal.pone.0189876. eCollection 2017. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forward-Step-Down Test	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.
Primary	Firefighter Specific Functional Balance Test	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.
Primary	Y-Balance Test	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.
Primary	Knee Extensor Isokinetic Test	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.
Primary	Hip Abductor Isokinetic Test	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	Rating of Fatigue	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.
Secondary	Rating of Perceived Exertion	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.
Secondary	Heartrate	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.