Dynamic Knee ValgusNCT06348836
The Effects of Open Chain Versus Closed Chain Strengthening on Dynamic Valgus During a Step Down Test
A study testing Exercise in people with Dynamic Knee Valgus, run by Alvernia University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dynamic Knee Valgus
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dynamic knee valgus with observed step down test
Who cannot join
- Presently experiencing lower extremity pain
- Lower extremity surgery within the past 1 year
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Alvernia University
Reading, Pennsylvania, 19607
James M O'Donohue, DPT, 610-334-1162, jim@odfamily.com
About this study
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.
Read the detailed 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.
- Conditions
- Dynamic Knee Valgus
- Being tested
- Exercise
- Keywords
- knee valgus, hip weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Closed-chain exercise, Open-chain exercise
Description of exercises are noted in the arms/groups descriptions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyographic activity of gluteus medius muscle during step-down test
Muscle activity of gluteus medius during max contraction and during step-down test
Measured: 6 weeks
Electromyographic activity of quadriceps muscle during step-down test
Muscle activity of quadriceps muscle during max contraction and during step-down test
Measured: 6 weeks
Electromyographic activity of hamstring muscles during step-down test
Muscle activity of hamstring muscles during max contraction and during step-down test
Measured: 6 weeks
Secondary outcomes (1)
Amount of dynamic knee valgus during step-down test measured with motion analysis
Motion analysis of frontal plane knee motion during step-down test
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start22 Mar 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Dynamic Knee ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either a closed-chain (weightbearing) exercise group or an open-chain (non-weightbearing) exercise group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alvernia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James O'Donohue, Alvernia University
- Investigators
- James M O'Donohue, DPT, Principal investigator, Alvernia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348836
- Sponsor's protocol ID
- 2123624-1/2
- Status last verified
- Mar 2024
- First submitted
- 30 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share data at this time
Publications
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.
PubMed 6722419Bunt CW, Jonas CE, Chang JG. Knee Pain in Adults and Adolescents: The Initial Evaluation. Am Fam Physician. 2018 Nov 1;98(9):576-585.
PubMed 30325638Fukuda 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.
PubMed 21041965Bolgla 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.
PubMed 30372640Dutton 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.
PubMed 26616176Hollman 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.
PubMed 19321910Stickler 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.
PubMed 25070759Scholtes 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.
PubMed 28593087Chowdhury 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.
PubMed 24048337Harris-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.
PubMed 24955621Simon 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.
PubMed 30414788Kunene 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.
PubMed 32161824Ismail 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.
PubMed 23820880Moore 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.
PubMed 33344003Boren 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.
PubMed 22034614
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Open Chain Versus Closed Chain Strengthening on Dynamic Valgus During a Step Down Test
- ClinicalTrials.gov ID
- NCT06348836
- Acronym / sponsor ID
- 2123624-1/2
- Conditions
- Dynamic Knee Valgus
- Keywords
- knee valgus, hip weakness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Alvernia UniversityUniversity, hospital or other
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either a closed-chain (weightbearing) exercise group or an open-chain (non-weightbearing) exercise group
| Arm | Type | Receives |
|---|---|---|
| Closed-Chain exercise | Active comparator | Other: Exercise4 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. |
| Open-Chain exercise | Active comparator | Other: Exercise4 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dynamic knee valgus with observed step down test
Key exclusion criteria (2 listed)
- Presently experiencing lower extremity pain
- Lower extremity surgery within the past 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Closed-chain exercise, Open-chain exerciseDescription of exercises are noted in the arms/groups descriptions | Other | Closed-Chain exercise, Open-Chain exercise |
Primary outcome
Electromyographic activity of gluteus medius muscle during step-down test
Time frame: 6 weeks
Muscle activity of gluteus medius during max contraction and during step-down test
Electromyographic activity of quadriceps muscle during step-down test
Time frame: 6 weeks
Muscle activity of quadriceps muscle during max contraction and during step-down test
Electromyographic activity of hamstring muscles during step-down test
Time frame: 6 weeks
Muscle activity of hamstring muscles during max contraction and during step-down test
1 secondary outcome
Amount of dynamic knee valgus during step-down test measured with motion analysis
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Background: PubMed 6722419Devereaux 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.
- Background: PubMed 30325638Bunt CW, Jonas CE, Chang JG. Knee Pain in Adults and Adolescents: The Initial Evaluation. Am Fam Physician. 2018 Nov 1;98(9):576-585.
- Background: PubMed 21041965Fukuda 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.
- Background: PubMed 30372640Bolgla 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.
- Background: PubMed 26616176Dutton 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.
- Background: PubMed 19321910Hollman 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.
- Background: PubMed 25070759Stickler 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.
- Background: PubMed 28593087Scholtes 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.
- Background: PubMed 24048337Chowdhury 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.
- Background: PubMed 24955621Harris-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.
- Background: PubMed 30414788Simon 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.
- Background: PubMed 32161824Kunene 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.
- Individual participant dataSharing planned: No. There is no plan to share data at this time
Related trials for Dynamic Knee Valgus
Not yet recruiting
Effects of Virtual Reality-Based Optokinetic Stimulation on Landing Technique and Dynamic Knee Valgus in Athletes
Dynamic Knee Valgus, Jump-Landing Technique
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
Not yet recruitingObservational study
Relation Between Degree of Lumbar Spine Curvature and Dynamic Knee Valgus in Smartphone Addicts
Low Back Pain
Recruiting
Effect of Corrective Exercises on Dynamic Knee Valgus
Dynamic Knee Valgus, Frontal Plan Projection Angle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James M O'Donohue, DPT principal investigator
Alvernia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Dynamic Knee Valgus, run by Alvernia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James M O'Donohue, DPT (6103341162, james.odonohue@alvernia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyographic activity of gluteus medius muscle during step-down test (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06348836, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.