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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06260306
Other study ID # STUDY00002568
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 24, 2024
Est. completion date April 12, 2024

Study information

Verified date April 2024
Source Louisiana State University Health Sciences Center Shreveport
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this investigation is to compare the effects of a combined hip activation and core stabilization training home exercise program (HEP) versus a hip activation training HEP alone on lower extremity (LE) frontal plane mechanics in healthy individuals. Specific Aim 1: To determine whether between- and/or within-group differences exist on the Forward Step-Down test (FSDT) when comparing a combined hip activation and core stabilization training HEP as compared to a hip activation training HEP. Specific Aim 2: To determine whether between- and/or within-group differences exist on the peak external knee abduction moment when comparing a combined hip activation and core stabilization training HEP to a hip activation training HEP. Specific Aim 3: To determine whether between- and/or within-group differences exist on gluteal and core muscle surface electromyography (sEMG) when comparing a combined hip activation and core stabilization training HEP to a hip activation training HEP. Specific Aim 4: To determine whether a dose-response relationship exists between HEP compliance and change on the FSDT, peak external knee abduction moment, and sEMG.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date April 12, 2024
Est. primary completion date April 12, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years and older
Eligibility Inclusion Criteria: - Participants will be current first- or second-year Doctor of Physical Therapy (DPT) students in the School of Allied Health Professions (SAHP) at Louisiana State University Health Shreveport over the age of 21. Exclusion Criteria: - Current pain or pathology in either LE which currently limits their ability to perform the FSDT or drop landing task, a history of low back pain in the last three months, known pregnancy, as pregnancy is a risk factor for diastasis rectus abdominis (DRA) which may be exacerbated by participation in the intervention and could be a confounding variable, and current participation in other clinical trials.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hip activation home exercise program
The hip activation HEP group will receive a combination of hip musculature activation exercises used by previous researchers that show an increase in hip muscle recruitment. Each participant will perform their respective intervention program at home twice weekly for eight weeks.
Hip activation plus core stabilization home exercise program
The hip activation plus core stabilization HEP group will receive the same hip exercises, plus core stabilization exercises used by previous researchers. Each participant will perform their respective intervention program at home twice weekly for eight weeks.

Locations

Country Name City State
United States LSU Health Sciences Center at 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 (25)

Argent R, Daly A, Caulfield B. Patient Involvement With Home-Based Exercise Programs: Can Connected Health Interventions Influence Adherence? JMIR Mhealth Uhealth. 2018 Mar 1;6(3):e47. doi: 10.2196/mhealth.8518. — View Citation

Bolgla LA, Boling MC, Mace KL, DiStefano MJ, Fithian DC, Powers CM. National Athletic Trainers' Association Position Statement: Management of Individuals With Patellofemoral Pain. J Athl Train. 2018 Sep;53(9):820-836. doi: 10.4085/1062-6050-231-15. — View Citation

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. — View Citation

Cavalli M, Aiolfi A, Bruni PG, Manfredini L, Lombardo F, Bonfanti MT, Bona D, Campanelli G. Prevalence and risk factors for diastasis recti abdominis: a review and proposal of a new anatomical variation. Hernia. 2021 Aug;25(4):883-890. doi: 10.1007/s10029 — View Citation

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

Fan B, Xia H, Xu J, Li Q, Shull PB. IMU-based knee flexion, abduction and internal rotation estimation during drop landing and cutting tasks. J Biomech. 2021 Jul 19;124:110549. doi: 10.1016/j.jbiomech.2021.110549. Epub 2021 Jun 13. — View Citation

Flowers DW, Brewer W, Ellison J, Mitchell K, Frilot C. Transversus abdominis activation does not alter gait impairments in patients with and without knee osteoarthritis. Clin Biomech (Bristol, Avon). 2021 Feb;82:105270. doi: 10.1016/j.clinbiomech.2020.105 — View Citation

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. do — View Citation

Gage BE, McIlvain NM, Collins CL, Fields SK, Comstock RD. Epidemiology of 6.6 million knee injuries presenting to United States emergency departments from 1999 through 2008. Acad Emerg Med. 2012 Apr;19(4):378-85. doi: 10.1111/j.1553-2712.2012.01315.x. — View Citation

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, Avon). 202 — View Citation

Huxel Bliven KC, Anderson BE. Core stability training for injury prevention. Sports Health. 2013 Nov;5(6):514-22. doi: 10.1177/1941738113481200. — View Citation

Ishida T, Koshino Y, Yamanaka M, Ueno R, Taniguchi S, Samukawa M, Saito H, Matsumoto H, Aoki Y, Tohyama H. The effects of a subsequent jump on the knee abduction angle during the early landing phase. BMC Musculoskelet Disord. 2018 Oct 20;19(1):379. doi: 1 — View Citation

Kim B, Yim J. Core Stability and Hip Exercises Improve Physical Function and Activity in Patients with Non-Specific Low Back Pain: A Randomized Controlled Trial. Tohoku J Exp Med. 2020 Jul;251(3):193-206. doi: 10.1620/tjem.251.193. — View Citation

Konrad P. The ABC of EMG: A Practical Introduction to Kinesiological Electromyography. Noraxon U.S.A.; 2006.

Leetun DT, Ireland ML, Willson JD, Ballantyne BT, Davis IM. Core stability measures as risk factors for lower extremity injury in athletes. Med Sci Sports Exerc. 2004 Jun;36(6):926-34. doi: 10.1249/01.mss.0000128145.75199.c3. — View Citation

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. — View Citation

Mascal CL, Landel R, Powers C. Management of patellofemoral pain targeting hip, pelvis, and trunk muscle function: 2 case reports. J Orthop Sports Phys Ther. 2003 Nov;33(11):647-60. doi: 10.2519/jospt.2003.33.11.647. — View Citation

McCallister E, Flowers D. 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. Published online 2020. do

McNair PJ, Prapavessis H. Normative data of vertical ground reaction forces during landing from a jump. J Sci Med Sport. 1999 Mar;2(1):86-8. doi: 10.1016/s1440-2440(99)80187-x. — View Citation

Nguyen US, Zhang Y, Zhu Y, Niu J, Zhang B, Felson DT. Increasing prevalence of knee pain and symptomatic knee osteoarthritis: survey and cohort data. Ann Intern Med. 2011 Dec 6;155(11):725-32. doi: 10.7326/0003-4819-155-11-201112060-00004. — View Citation

Okubo Y, Kaneoka K, Imai A, Shiina I, Tatsumura M, Izumi S, Miyakawa S. Electromyographic analysis of transversus abdominis and lumbar multifidus using wire electrodes during lumbar stabilization exercises. J Orthop Sports Phys Ther. 2010 Nov;40(11):743-5 — 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

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. — View Citation

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/jo — View Citation

* Note: There are 25 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Forward Step Down Test (FSDT) Rating on the FSDT (0-6; 0-1 = good movement quality, 2-3 = moderate movement quality, 4 or more = poor movement quality). Pre- and post-eight week intervention
Secondary Maximal volitional isometric contraction (MVIC) via sensory electromyography (sEMG) of gluteus maximus (GMax) MVIC (microvolts) of GMax during performance of the FSDT Pre- and post-eight week intervention
Secondary Mean activation of GMax via sEMG Mean activation (% MVIC) of GMax during performance of the FSDT Pre- and post-eight week intervention
Secondary Peak activation of GMax via sEMG Peak activation (%MVIC) of GMax during performance of the FSDT Pre- and post-eight week intervention
Secondary MVIC via sEMG of gluteus medius (GMed) MVIC (microvolts) of GMed during performance of the FSDT Pre- and post-eight week intervention
Secondary Mean activation of GMed via sEMG Mean activation (% MVIC) of GMed during performance of the FSDT Pre- and post-eight week intervention
Secondary Peak activation of GMed via sEMG Peak activation (% MVIC) of GMed during performance of the FSDT Pre- and post-eight week intervention
Secondary MVIC via of transversus abdominis (TA) MVIC (microvolts) of TA during performance of the FSDT Pre- and post-eight week intervention
Secondary Mean activation of TA via sEMG Mean activation (% MVIC) of TA during performance of the FSDT Pre- and post-eight week intervention
Secondary Peak activation of TA via sEMG Peak activation (% MVIC) of TA during performance of FSDT Pre- and post-eight week intervention
Secondary Peak external knee abduction moment during drop landing task Kinetic assessment of the peak external knee abduction moment (Nm/kg) during the drop landing task Pre- and post-eight week intervention
Secondary Compliance with Home Exercise Program Self-reported completion of each HEP session will be recorded by the participant and then returned to the investigators post-completion Post-eight week intervention
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