NCT06445491

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

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 22, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 23, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

May 22, 2024

Last Update Submit

December 10, 2024

Conditions

Keywords

strengthdynamic balancemovement qualityinjury prevention

Outcome Measures

Primary Outcomes (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (3)

  • Rating of Fatigue

    This outcome will be assessed at each visit throughout the study, an average of 6 weeks.

  • Rating of Perceived Exertion

    This outcome will be assessed at each visit throughout the study, an average of 6 weeks.

  • Heartrate

    This outcome will be assessed at each visit throughout the study, an average of 6 weeks.

Study Arms (2)

control trial

ACTIVE COMPARATOR

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

sequenced trials

EXPERIMENTAL

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

Interventions

Participants will perform an initial baseline of tests, order of 1- 2- 3

control trial

the testing order will be randomized for follow up testing.

sequenced trials

Eligibility Criteria

Age18 Years - 57 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adult by Physical Activity Readiness Questionnaire+ screening process

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSUHSC-Shreveport

Shreveport, Louisiana, 71103, United States

Location

Related Publications (12)

  • 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.

    PMID: 5614624BACKGROUND
  • 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.

    PMID: 31876454BACKGROUND
  • 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.

    PMID: 21655382BACKGROUND
  • 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.

    PMID: 28759729BACKGROUND
  • 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.

    PMID: 29034800BACKGROUND
  • 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.

    PMID: 23756380BACKGROUND
  • 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).

    BACKGROUND
  • 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.

    PMID: 20118526BACKGROUND
  • 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.

    PMID: 29287067BACKGROUND
  • 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.

    PMID: 22715125BACKGROUND
  • 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.

    PMID: 18845450BACKGROUND
  • 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.

    PMID: 27423208BACKGROUND

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Erin McCallister, DPT

    LSUHSC-Shreveport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: All participants will receive all 6 iterations of testing order, but the order of test sequences will be randomized.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2024

First Posted

June 6, 2024

Study Start

July 23, 2024

Primary Completion

September 30, 2024

Study Completion

October 15, 2024

Last Updated

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations