NCT06348836

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 22, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

April 5, 2024

Status Verified

March 1, 2024

Enrollment Period

11 months

First QC Date

March 30, 2024

Last Update Submit

March 30, 2024

Conditions

Keywords

knee valguship weakness

Outcome Measures

Primary Outcomes (3)

  • 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

  • Electromyographic activity of quadriceps muscle during step-down test

    Muscle activity of quadriceps muscle during max contraction and during step-down test

    6 weeks

  • 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 Outcomes (1)

  • Amount of dynamic knee valgus during step-down test measured with motion analysis

    6 weeks

Study Arms (2)

Closed-Chain exercise

ACTIVE COMPARATOR

4 exercises: 1)Single leg bridge, 2)side plank (with testing side down), 3) single leg squat, 4) banded squat Exercises to be performed with 3 sets of 10 repetitions each. Frequency will be 2 times per week for 6 weeks.

Other: Exercise

Open-Chain exercise

ACTIVE COMPARATOR

4 exercises: 1) Side plank (with testing side up), 2) clamshells, 3) front plank with hip extension, 4)wall slide Exercises to be performed with 3 sets of 10 repetitions each. Frequency will be 2 times per week for 6 weeks.

Other: Exercise

Interventions

Description of exercises are noted in the arms/groups descriptions

Also known as: Closed-chain exercise, Open-chain exercise
Closed-Chain exerciseOpen-Chain exercise

Eligibility Criteria

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

You may qualify if:

  • Dynamic knee valgus with observed step down test

You may not qualify if:

  • Presently experiencing lower extremity pain
  • Lower extremity surgery within the past 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alvernia University

Reading, Pennsylvania, 19607, United States

RECRUITING

Related Publications (16)

  • 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.

    PMID: 6722419BACKGROUND
  • 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.

    PMID: 30325638BACKGROUND
  • 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.

    PMID: 21041965BACKGROUND
  • 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.

    PMID: 30372640BACKGROUND
  • 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.

    PMID: 26616176BACKGROUND
  • 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.

    PMID: 19321910BACKGROUND
  • 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.

    PMID: 25070759BACKGROUND
  • 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.

    PMID: 28593087BACKGROUND
  • 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.

    PMID: 24048337BACKGROUND
  • 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.

    PMID: 24955621BACKGROUND
  • 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.

    PMID: 30414788BACKGROUND
  • 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.

    PMID: 32161824BACKGROUND
  • 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.

    PMID: 23820880BACKGROUND
  • 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.

    PMID: 33344003BACKGROUND
  • 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.

    PMID: 22034614BACKGROUND
  • 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.

    PMID: 21765220BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • James M O'Donohue, DPT

    Alvernia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James M O'Donohue, DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either a closed-chain (weightbearing) exercise group or an open-chain (non-weightbearing) exercise group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Physical Therapy

Study Record Dates

First Submitted

March 30, 2024

First Posted

April 5, 2024

Study Start

March 22, 2024

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

April 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

There is no plan to share data at this time

Locations