NCT06298903

Brief Summary

The purpose of this research is to determine the impact of a hip activation home exercise program (HEP) compared to a hip activation + single leg balance HEP on performance of the Forward-Step-Down Test (FSDT) in healthy females. Participants will be assigned to the control (hip activation HEP only) or experimental (hip activation + single leg balance HEP). Following the pre-test data collection, participants will complete their HEP for 8 weeks. They will return to the lab for post-test measurements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 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

Study Start

First participant enrolled

January 12, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

January 19, 2024

Last Update Submit

December 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    pre-intervention (baseline), post-intervention (8 weeks)

Secondary Outcomes (4)

  • surface electromyography (sEMG) peak

    pre-intervention (baseline), post-intervention (8 weeks)

  • surface electromyography (sEMG) mean

    pre-intervention (baseline), post-intervention (8 weeks)

  • Unipedal Stance Test (UPST)

    pre-intervention (baseline), post-intervention (8 weeks)

  • Dose-Response

    post-intervention (8 weeks)

Study Arms (2)

Hip activation

ACTIVE COMPARATOR

Participants will perform a hip muscle activation program 2 days per week for 8 weeks. The HEP consists of 5 exercises that target the gluteal muscles.

Other: Hip Activation

Hip activation + Single leg balance

EXPERIMENTAL

Participants will perform a hip muscle activation program as in the active comparator group, plus a single leg balance training HEP 2 days per week for 8 weeks. The hip HEP consists of 5 exercises that target the gluteal muscles. The single leg balance HEP consists of a variety of eyes open and eyes closed single leg balance exercises.

Other: Hip activation + Single leg balance

Interventions

Sidelying hip abduction, side plank with hip abduction, clamshell (hip abduction + external rotation), side plan with clamshell, and quadruped fire hydrant exercises will be performed for 1 minute isometric holds, 2 times per week for 8 weeks.

Hip activation

Hip activation HEP: Sidelying hip abduction, side plank with hip abduction, clamshell (hip abduction + external rotation), side plan with clamshell, and quadruped fire hydrant exercises will be performed for 1 minute isometric holds, 2 times per week for 8 weeks. Single leg balance: variety of single leg balance exercises with different upper extremity and lower extremity positions to provide different balance stimuli. Weeks are alternated performing these exercises with eyes open and eyes closed.

Hip activation + Single leg balance

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • first or second year students at the institutions's School of Allied Health Professions
  • healthy
  • female

You may not qualify if:

  • participating in another research study
  • current knee pain or pathology on the dominant leg
  • known diagnosis of vestibular impairment
  • known pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSUHSC-Shreveport

Shreveport, Louisiana, 71103, United States

Location

Related Publications (29)

  • Cannon J, Weithman BA, Powers CM. Activation training facilitates gluteus maximus recruitment during weight-bearing strengthening exercises. J Electromyogr Kinesiol. 2022 Apr;63:102643. doi: 10.1016/j.jelekin.2022.102643. Epub 2022 Feb 9.

    PMID: 35189569BACKGROUND
  • Rinaldi VG, Prill R, Jahnke S, Zaffagnini S, Becker R. The influence of gluteal muscle strength deficits on dynamic knee valgus: a scoping review. J Exp Orthop. 2022 Aug 17;9(1):81. doi: 10.1186/s40634-022-00513-8.

    PMID: 35976534BACKGROUND
  • Wilczynski B, Zorena K, Slezak D. Dynamic Knee Valgus in Single-Leg Movement Tasks. Potentially Modifiable Factors and Exercise Training Options. A Literature Review. Int J Environ Res Public Health. 2020 Nov 6;17(21):8208. doi: 10.3390/ijerph17218208.

    PMID: 33172101BACKGROUND
  • Khayambashi K, Mohammadkhani Z, Ghaznavi K, Lyle MA, Powers CM. The effects of isolated hip abductor and external rotator muscle strengthening on pain, health status, and hip strength in females with patellofemoral pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):22-9. doi: 10.2519/jospt.2012.3704. Epub 2011 Oct 25.

    PMID: 22027216BACKGROUND
  • Khayambashi K, Fallah A, Movahedi A, Bagwell J, Powers C. Posterolateral hip muscle strengthening versus quadriceps strengthening for patellofemoral pain: a comparative control trial. Arch Phys Med Rehabil. 2014 May;95(5):900-7. doi: 10.1016/j.apmr.2013.12.022. Epub 2014 Jan 16.

    PMID: 24440362BACKGROUND
  • Hott A, Liavaag S, Juel NG, Brox JI. Study protocol: a randomised controlled trial comparing the long term effects of isolated hip strengthening, quadriceps-based training and free physical activity for patellofemoral pain syndrome (anterior knee pain). BMC Musculoskelet Disord. 2015 Feb 25;16:40. doi: 10.1186/s12891-015-0493-6.

    PMID: 25879452BACKGROUND
  • Hewett TE, Myer GD, Ford KR. Decrease in neuromuscular control about the knee with maturation in female athletes. J Bone Joint Surg Am. 2004 Aug;86(8):1601-8. doi: 10.2106/00004623-200408000-00001.

    PMID: 15292405BACKGROUND
  • Lee SP, Powers CM. Individuals with diminished hip abductor muscle strength exhibit altered ankle biomechanics and neuromuscular activation during unipedal balance tasks. Gait Posture. 2014 Mar;39(3):933-8. doi: 10.1016/j.gaitpost.2013.12.004. Epub 2013 Dec 12.

    PMID: 24373699BACKGROUND
  • Hatton AL, Kemp JL, Brauer SG, Clark RA, Crossley KM. Impairment of dynamic single-leg balance performance in individuals with hip chondropathy. Arthritis Care Res (Hoboken). 2014 May;66(5):709-16. doi: 10.1002/acr.22193.

    PMID: 24115764BACKGROUND
  • Alfuth M, Gomoll M. Electromyographic analysis of balance exercises in single-leg stance using different instability modalities of the forefoot and rearfoot. Phys Ther Sport. 2018 May;31:75-82. doi: 10.1016/j.ptsp.2018.01.002. Epub 2018 Mar 21.

    PMID: 29573984BACKGROUND
  • Anguish B, Sandrey MA. Two 4-Week Balance-Training Programs for Chronic Ankle Instability. J Athl Train. 2018 Jul;53(7):662-671. doi: 10.4085/1062-6050-555-16.

    PMID: 30192681BACKGROUND
  • Rothermel S, Hale S, Hertel J, Denegar C. Effect of active foot positioning on the outcome of a balance training program. Physical Therapy in Sport. 2004. 5:2 (98-103). https://doi.org/10.1016/j.ptsp.2004.02.002.

    BACKGROUND
  • McCallister E, Flowers DW. Can the Forward-Step-Down Test Be Used Reliably in the Clinical Setting to Assess Movement Changes Resulting from Maximal Exertion? A Pilot Study. The Internet Journal of Allied Health Sciences and Practice. 2020 Jan 01;18(4), Article 7. doi: 10.46743/1540-580X/2020.1931

    BACKGROUND
  • Hopper AJ, Haff EE, Joyce C, Lloyd RS, Haff GG. Neuromuscular Training Improves Lower Extremity Biomechanics Associated with Knee Injury during Landing in 11-13 Year Old Female Netball Athletes: A Randomized Control Study. Front Physiol. 2017 Nov 7;8:883. doi: 10.3389/fphys.2017.00883. eCollection 2017.

    PMID: 29163219BACKGROUND
  • McGovern RP, Martin RL, Christoforetti JJ, Kivlan BR. EVIDENCE-BASED PROCEDURES FOR PERFORMING THE SINGLE LEG SQUAT AND STEP-DOWN TESTS IN EVALUATION OF NON-ARTHRITIC HIP PAIN: A LITERATURE REVIEW. Int J Sports Phys Ther. 2018 Jun;13(3):526-536.

    PMID: 30038839BACKGROUND
  • Fisher BE, Southam AC, Kuo YL, Lee YY, Powers CM. Evidence of altered corticomotor excitability following targeted activation of gluteus maximus training in healthy individuals. Neuroreport. 2016 Apr 13;27(6):415-21. doi: 10.1097/WNR.0000000000000556.

    PMID: 26981714BACKGROUND
  • Loudon JK, Wiesner D, Goist-Foley HL, Asjes C, Loudon KL. Intrarater Reliability of Functional Performance Tests for Subjects With Patellofemoral Pain Syndrome. J Athl Train. 2002 Sep;37(3):256-261.

    PMID: 12937582BACKGROUND
  • Springer BA, Marin R, Cyhan T, Roberts H, Gill NW. Normative values for the unipedal stance test with eyes open and closed. J Geriatr Phys Ther. 2007;30(1):8-15. doi: 10.1519/00139143-200704000-00003.

    PMID: 19839175BACKGROUND
  • Flowers DW, Brewer W, Mitchell K, Ellison J, Frilot C. The Effect of Core Stabilization Training on Improving Gait and Self-Perceived Function in Patients with Knee Osteoarthritis: A Single-Arm Clinical Trial. Pathophysiology. 2022 Sep 1;29(3):495-506. doi: 10.3390/pathophysiology29030040.

    PMID: 36136067BACKGROUND
  • Clark L, Dean A, Mitchell A, & Torgerson DJ. Envelope use and reporting in randomised controlled trials: a guide for researchers. Research Methods in Medicine & Health Sciences. 2021;2(1):2-11. doi:10.1177/2632084320957204

    BACKGROUND
  • 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
  • Konrad P. The ABC of EMG: A Practical Introduction to Kinesiological Electromyography.

    BACKGROUND
  • Distefano LJ, Blackburn JT, Marshall SW, Padua DA. Gluteal muscle activation during common therapeutic exercises. J Orthop Sports Phys Ther. 2009 Jul;39(7):532-40. doi: 10.2519/jospt.2009.2796.

    PMID: 19574661BACKGROUND
  • Selkowitz DM, Beneck GJ, Powers CM. Comparison of Electromyographic Activity of the Superior and Inferior Portions of the Gluteus Maximus Muscle During Common Therapeutic Exercises. J Orthop Sports Phys Ther. 2016 Sep;46(9):794-9. doi: 10.2519/jospt.2016.6493. Epub 2016 Aug 5.

    PMID: 27494053BACKGROUND
  • Harput G, Ulusoy B, Akmese R, Ergun N. Comparison of muscle activation levels and knee valgus between individuals with medial patellofemoral ligament reconstruction and healthy individuals during fatiguing step down task. Clin Biomech (Bristol). 2020 Aug;78:105067. doi: 10.1016/j.clinbiomech.2020.105067. Epub 2020 Jun 6.

    PMID: 32535475BACKGROUND
  • Selkowitz DM, Beneck GJ, Powers CM. Which exercises target the gluteal muscles while minimizing activation of the tensor fascia lata? Electromyographic assessment using fine-wire electrodes. J Orthop Sports Phys Ther. 2013 Feb;43(2):54-64. doi: 10.2519/jospt.2013.4116. Epub 2012 Nov 16.

    PMID: 23160432BACKGROUND
  • Chan MK, Chow KW, Lai AY, Mak NK, Sze JC, Tsang SM. The effects of therapeutic hip exercise with abdominal core activation on recruitment of the hip muscles. BMC Musculoskelet Disord. 2017 Jul 21;18(1):313. doi: 10.1186/s12891-017-1674-2.

    PMID: 28732494BACKGROUND
  • Henry KD, Rosemond C, Eckert LB. Effect of number of home exercises on compliance and performance in adults over 65 years of age. Phys Ther. 1999 Mar;79(3):270-7.

    PMID: 10078770BACKGROUND
  • Eckard T, Lopez J, Kaus A, Aden J. Home exercise program compliance of service members in the deployed environment: an observational cohort study. Mil Med. 2015 Feb;180(2):186-91. doi: 10.7205/MILMED-D-14-00306.

    PMID: 25643386BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Erin McCallister, DPT

    LSUHSC-Shreveport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The investigator who will analyze the data will be blinded
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2024

First Posted

March 7, 2024

Study Start

January 12, 2024

Primary Completion

March 25, 2024

Study Completion

August 1, 2024

Last Updated

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations