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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06348836
Other study ID # 2123624-1/2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 22, 2024
Est. completion date February 28, 2025

Study information

Verified date March 2024
Source Alvernia University
Contact James M O'Donohue, DPT
Phone 6103341162
Email james.odonohue@alvernia.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the effects of different exercises programs in individuals with abnormal knee motion. The main question it aims to answer are: - In individuals with abnormal knee motion and without knee pain, does a weight-bearing exercise program reduce abnormal knee motion during a step-down test better than a non weight-bearing exercise program? Participants will - Perform a stepdown test while undergoing motion analysis and electromyograph (EMG) recording. - Participants will then be placed either into a weight-bearing or non weight-bearing exercise group. Exercises will be performed 3 times per week for 6 weeks. - Further motion analysis and EMG data will be collected to test for differences. Researchers will compare individual results before and after exercise, and between-group results before and after exercise to see if one exercise program helps improved abnormal knee motion more than the other.


Description:

The goals of this trial is to compare the effects of a closed kinetic chain exercise program to an open kinetic chain exercise program in individuals without knee pain who also have dynamic knee valgus during a step-down test. Individuals will be screened for participation via visual observation. Those with an observable medial collapse of the knee joint will then receive motion capture testing of the step down test (three trials) with electromyography recording of the gluteus medius, quadriceps and hamstring muscle groups. Baseline maximum voluntary contraction of these muscles will be done with EMG analysis and force gauge measurements. After initial data collection participants will be randomized into either a closed kinetic chain exercise group or open kinetic chain exercise group. (described in the Arms section) Participants will exercise 2-3 times per week for 6 weeks. After the exercise program is completed, participants will then be seen back for final data collection which will match the initial collection process.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date February 28, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Dynamic knee valgus with observed step down test Exclusion Criteria: - Presently experiencing lower extremity pain - Lower extremity surgery within the past 1 year

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
Description of exercises are noted in the arms/groups descriptions

Locations

Country Name City State
United States Alvernia University Reading Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Alvernia University

Country where clinical trial is conducted

United States, 

References & Publications (16)

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

Boren K, Conrey C, Le Coguic J, Paprocki L, Voight M, Robinson TK. Electromyographic analysis of gluteus medius and gluteus maximus during rehabilitation exercises. Int J Sports Phys Ther. 2011 Sep;6(3):206-23. — View Citation

Bunt CW, Jonas CE, Chang JG. Knee Pain in Adults and Adolescents: The Initial Evaluation. Am Fam Physician. 2018 Nov 1;98(9):576-585. — View Citation

Chowdhury RH, Reaz MB, Ali MA, Bakar AA, Chellappan K, Chang TG. Surface electromyography signal processing and classification techniques. Sensors (Basel). 2013 Sep 17;13(9):12431-66. doi: 10.3390/s130912431. — View Citation

Devereaux MD, Lachmann SM. Patello-femoral arthralgia in athletes attending a Sports Injury Clinic. Br J Sports Med. 1984 Mar;18(1):18-21. doi: 10.1136/bjsm.18.1.18. — View Citation

Dutton RA, Khadavi MJ, Fredericson M. Patellofemoral Pain. Phys Med Rehabil Clin N Am. 2016 Feb;27(1):31-52. doi: 10.1016/j.pmr.2015.08.002. — View Citation

Fukuda TY, Rossetto FM, Magalhaes E, Bryk FF, Lucareli PR, de Almeida Aparecida Carvalho N. Short-term effects of hip abductors and lateral rotators strengthening in females with patellofemoral pain syndrome: a randomized controlled clinical trial. J Orthop Sports Phys Ther. 2010 Nov;40(11):736-42. doi: 10.2519/jospt.2010.3246. — View Citation

Harris-Hayes M, Steger-May K, Koh C, Royer NK, Graci V, Salsich GB. Classification of lower extremity movement patterns based on visual assessment: reliability and correlation with 2-dimensional video analysis. J Athl Train. 2014 May-Jun;49(3):304-10. doi: 10.4085/1062-6050-49.2.21. — View Citation

Hollman JH, Ginos BE, Kozuchowski J, Vaughn AS, Krause DA, Youdas JW. Relationships between knee valgus, hip-muscle strength, and hip-muscle recruitment during a single-limb step-down. J Sport Rehabil. 2009 Feb;18(1):104-17. doi: 10.1123/jsr.18.1.104. — View Citation

Ismail MM, Gamaleldein MH, Hassa KA. Closed kinetic chain exercises with or without additional hip strengthening exercises in management of patellofemoral pain syndrome: a randomized controlled trial. Eur J Phys Rehabil Med. 2013 Oct;49(5):687-98. Epub 2013 Jul 2. — View Citation

Kunene SH, Taukobong NP, Ramklass S. Rehabilitation approaches to anterior knee pain among runners: A scoping review. S Afr J Physiother. 2020 Jan 27;76(1):1342. doi: 10.4102/sajp.v76i1.1342. eCollection 2020. — View Citation

Moore D, Semciw AI, Pizzari T. A SYSTEMATIC REVIEW AND META-ANALYSIS OF COMMON THERAPEUTIC EXERCISES THAT GENERATE HIGHEST MUSCLE ACTIVITY IN THE GLUTEUS MEDIUS AND GLUTEUS MINIMUS SEGMENTS. Int J Sports Phys Ther. 2020 Dec;15(6):856-881. doi: 10.26603/ijspt20200856. — View Citation

Scholtes SA, Salsich GB. A DYNAMIC VALGUS INDEX THAT COMBINES HIP AND KNEE ANGLES: ASSESSMENT OF UTILITY IN FEMALES WITH PATELLOFEMORAL PAIN. Int J Sports Phys Ther. 2017 Jun;12(3):333-340. — View Citation

Simon M, Parizek C, Earl-Boehm JE, Bazett-Jones DM. Quantitative and qualitative assessment of frontal plane knee motion in males and females: A reliability and validity study. Knee. 2018 Dec;25(6):1057-1064. doi: 10.1016/j.knee.2018.09.008. Epub 2018 Nov 8. — View Citation

Stickler L, Finley M, Gulgin H. Relationship between hip and core strength and frontal plane alignment during a single leg squat. Phys Ther Sport. 2015 Feb;16(1):66-71. doi: 10.1016/j.ptsp.2014.05.002. Epub 2014 Jun 3. — View Citation

Willy RW, Davis IS. The effect of a hip-strengthening program on mechanics during running and during a single-leg squat. J Orthop Sports Phys Ther. 2011 Sep;41(9):625-32. doi: 10.2519/jospt.2011.3470. Epub 2011 Jul 12. — View Citation

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Electromyographic activity of gluteus medius muscle during step-down test Muscle activity of gluteus medius during max contraction and during step-down test 6 weeks
Primary Electromyographic activity of quadriceps muscle during step-down test Muscle activity of quadriceps muscle during max contraction and during step-down test 6 weeks
Primary Electromyographic activity of hamstring muscles during step-down test Muscle activity of hamstring muscles during max contraction and during step-down test 6 weeks
Secondary Amount of dynamic knee valgus during step-down test measured with motion analysis Motion analysis of frontal plane knee motion during step-down test 6 weeks
See also
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Completed NCT05695482 - Progressive Resistance Training Compared to Neuromuscular Exercises on Knee Kinematics N/A