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Knee OsteoarthritisNCT03663790

Effects of Gait Retraining on Lower Extremity Biomechanics

A study testing Foot Progression and Trunk Lean in people with Knee Osteoarthritis, run by George Mason University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this proposed study is to investigate both the acute and chronic response of frontal plane knee moment after gait retraining and to assess the effects on the biomechanics of the contralateral side. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Foot Progression and Trunk Lean
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
10 Oct 2018to 1 Oct 2026
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • a clinical diagnosis of knee osteoarthritis by a qualified health professional such as an orthopedic surgeon or physical therapist
  • between the ages of 18 and 80
  • able to walk unaided for a minimum of 20 minutes

Who cannot join

  • body mass index greater than 35
  • history of lower back, hip or, knee surgery within the last 2 years
  • knee arthroscopy or pharmacological injection in the previous six months
  • neurological, or musculoskeletal conditions affecting ambulation
  • cognitive impairment that would inhibit motor learning
  • use of gait aid, orthotic shoe inserts, or hinged knee brace

Trial locations and contacts

1 site in 1 country.

Oladipo Eddo contact

7039937183

oeddo@gmu.edu

United States1 site, 1 recruiting
  • Sports Medicine, Assessment, Research & Testing (SMART) Laboratory

    Manassas, Virginia, 20110

    Oladipo Eddo, PhD

    Oladipo Eddo, PhD

    Recruiting

Other trials in United States

About this study

Official title: Comparison of the Effects of Gait Modification Strategies on Knee Adduction Moment in Patients With Medial Knee Osteoarthritis: Randomized Controlled Trial

The purpose of this proposed study is to investigate both the acute and chronic response of frontal plane knee moment after gait retraining and to assess the effects on the biomechanics of the contralateral side. Fifty-one patients diagnosed with tibiofemoral joint osteoarthritis (TFJ OA) will be recruited to participate in the proposed study. Participants will complete baseline trials to assess gait kinematic and kinetic parameters. Following baseline, each participant will perform six conditions of the foot progression gait or three conditions of the trunk lean gait modifications to determine which strategy is most effective in reducing frontal plane knee moment. Participants will then be randomized to either the control or experimental group based on their identified preferred strategy.

Participants will complete eight gait retraining sessions using patient-specific gait modifications (tailored foot progression and tailored lateral trunk lean), or normal gait (control) during the training period. A fading feedback design will be implemented. Real-time haptic biofeedback will be provided on every step during the first two weeks and reduced by 25% every subsequent two weeks. No feedback will be provided during baseline and at testing sessions. Measures of pain and function will also be collected at all testing sessions. Variables of interest include ankle, knee, hip sagittal and frontal plane moments. In addition, sagittal and frontal plane impulse will also be assessed.

Descriptive statistics will be calculated for foot progression angle, trunk lean angle, frontal and sagittal plane hip, knee, and ankle angles as well as moments. Descriptive statistics for frontal plane knee impulse will also be calculated. A multivariate analysis of variance (MANOVA) will be conducted to compare frontal plane knee moment, frontal plane knee impulse and the absolute sagittal plane moment will be compared across three groups at four different time points. Repeated measures analysis of variance (ANOVA) will be conducted to compare both sagittal and frontal plane joint biomechanics for the contralateral limb. The p-value will be set at .05.

Read the detailed description

A randomized controlled study design with a waitlist will be used to investigate the effects of a 10-week gait retraining intervention on the knee adduction moment. Participants will be randomly assigned to either the intervention group or the control group. The intervention group will be further split into two groups. One group will consist of participants who reduced knee adduction moment (KAM) most with altered foot progression gait and the other will consist of participants who reduce KAM most effectively with trunk lean gait during pre-assessment. Participants will then perform 8 gait retraining sessions over 8 weeks (one session per week) using either their specific gait modification strategy (intervention) or with their normal gait (control). As part of the waitlist design, at the end of 10 weeks, patients assigned to the control group will be reassigned to their previously determined patient specific gait modification intervention. The goal is to minimize attrition and to increase the effective sample size.

On arrival to the laboratory, participants will be required to read and sign an informed consent form. Participant height and mass will be recorded. Pain and function will be assessed using the Western Ontario and McMaster Universities Arthritis (WOMAC) questionnaire and a numeric rating scale (NRS) from zero to 10, where zero represents no pain and 10 the highest level of pain. The experimental limb for the purpose of this study is defined as the leg diagnosed with symptomatic TFJ OA or the most symptomatic limb in the case of bilateral OA. Participants will be equipped with 4 surface electromyogram (sEMG) placed on the rectus femoris, vastus medialis, bicep femoris and semitendinosus of the experimental limb. EMG sensors will be used to record muscle activity during the baseline test. Participants will then have 53 retroreflective markers attached to their trunk and lower extremities. A static calibration trial of the VICON motion capture system will be acquired by having the participants stand on the foremost force plate with both feet aligned with the anterior-posterior axis of the laboratory. Participants will also perform a dynamic calibration by completing three clockwise rotations of the hip which will be used to estimate the hip joint centers. Participants will then complete 5 baseline walking trials along with a 6-meter walkway at their preferred speed. Participants will be required to walk for 12 minutes on a treadmill, and additional data will be recorded. Participants will then be required perform 9 conditions with altered foot progression gait or trunk lean gait to determine which strategy is most effective in reducing KAM. Participants will first receive standardized verbal instructions on how to achieve the instructed gait modification. Participants will then be provided haptic real-time biofeedback to ensure that they successfully achieve the required magnitudes of gait modification. Kinematic data collected in Vicon will be streamed to Matlab (Mathworks, Natick, MA) for real-time computation of joint angles. Participants will receive feedback from tactile sensors attached either to the lateral-proximal aspect of the fibula (foot progression) or the center of the scapula (lateral trunk lean) of the experimental side with hypoallergenic double-sided tape. One vibration will indicate a required decrease in the target gait parameter, while two vibrations will indicate a required increase. Feedback will be provided on each step and no vibration will indicate that no correction is needed. A trial will only be considered valid if the participant fully contacted the force plates twice with the foot of the experimental limb and the modified parameter was in the prescribed target range. Additionally, participants will be required to maintain an average gait speed ±5% relative to baseline for trials to be considered successful. The modification to be completed in the baseline session will be randomized for each participant. Once these trials are completed, participants will return to the lab within the same week to complete 5 additional baseline trials and three trials of whichever gait modification they did not perform the first day. Each baseline data collection session will take approximately one hour.

Participants will then be randomly assigned to either the intervention group or the control group. The intervention group will be further split into two groups. One group will consist of participants who reduced KAM most with altered foot progression gait and the other will consist of participants who reduce KAM most effectively with trunk lean gait. Participants will then perform 8 gait retraining sessions over 8 weeks (one session per week) using either their specific gait modification strategy (intervention) or with their normal gait (control). During gait-retraining sessions, participants will walk on a Woodway Desmo treadmill (Woodway, Waukesha, WI) placed in the center of a calibrated volume area (approximately 0.5 x 1.5 meters). A three-camera high-speed motion analysis system (Vicon, Oxford, England) sampling at 200 Hz will be used to record gait kinematics. The indicated anatomical landmarks (either C7 and T10 or posterior calcaneus and 2nd metatarsal phalangeal joint) will be marked with an ultraviolet pen, which will allow for visibility for a week, and will be reapplied at subsequent visits. This will improve marker placement repeatability during the gait retraining phase. A five-minute dynamic warm-up will be provided prior to the commencement of each gait retraining session; participants will then walk with their individualized gait modification strategy for 20 minutes. Participants will be provided with haptic feedback in the same manner outlined during the individualization phase or will continue to walk without feedback. A fading feedback design will be implemented across sessions to gradually integrate task acquisition and transfer and to help facilitate the internalization of the learned skill. During the first 2 weeks, real-time biofeedback (RTB) will be delivered on every step. For the third and fourth week, RTB will be provided on the first 3 foot strikes by the experimental leg and withheld on the fourth indicating a 25% reduction. During the fifth and sixth week, feedback will be provided on alternating foot strikes reducing RTB frequency delivery to 50%. For the final two weeks of gait-retraining, no feedback will be provided on the first three steps but delivered on the fourth reducing RTB frequency to 25%.

Between gait retraining sessions, subjects will be instructed to practice their acquired gait strategy on their own outside of the laboratory session, which will occur in the absence of feedback. They will be instructed to practice at least 10 min per day and will be provided weekly activity logs to record time of day and amount practiced each day during the eight weeks of gait retraining. Practice logs will be submitted weekly. Over-ground gait analysis and 12 minutes of treadmill walking will be performed at week 4 (first post-test) and 9 (2nd post-test) over the course of the intervention to track skill acquisition. This testing will be the same as the baseline trials, however, participants will be instructed to walk using only their specific gait modification strategy. No feedback will be provided during any of the skill acquisition or retention tests. Follow-up testing will occur at one, three, and six months as well as one-year post-intervention to measure retention of prescribed gait modifications.

Being tested
Foot Progression, Trunk Lean
Keywords
osteoarthritis, biomechanics, gait retraining, real-time biofeedback, knee
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Foot ProgressionOther

    The intervention will be a gait retraining biofeedback focused on foot angle during gait trials

  • Trunk LeanOther

    The intervention will be a gait retraining biofeedback focused on trunk lean angle during gait trials

Study groups in NCT03663790
Study groupRoleWhat they receive
ControlNo interventionNo intervention
Foot ProgressionExperimentalParticipants will visualize a desired foot progression angle bandwidth in real-time that they should target with their foot angle
Receives: Other: Foot Progression
Trunk LeanExperimentalParticipants will visualize a desired trunk lean angle bandwidth in real-time that they should target with their trunk lean angle
Receives: Other: Trunk Lean

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Knee Adduction Moment from Baseline at 10-weeks

    The knee adduction moment is a surrogate measure to evaluate knee joint loads.

    Measured: It will be assessed using biomechanical analysis at baseline and 10-weeks gait retraining intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2018
  2. Study start10 Oct 2018
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03663790
Sponsor's protocol ID
Gait retraining OA
Status last verified
Oct 2023
First submitted
4 Sep 2018
Last updated
26 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Allen KD, Golightly YM. State of the evidence. Curr Opin Rheumatol. 2015 May;27(3):276-83. doi: 10.1097/BOR.0000000000000161.

    PubMed 25775186
  • Amin S, Luepongsak N, McGibbon CA, LaValley MP, Krebs DE, Felson DT. Knee adduction moment and development of chronic knee pain in elders. Arthritis Rheum. 2004 Jun 15;51(3):371-6. doi: 10.1002/art.20396.

    PubMed 15188321
  • Anderson DI, Magill RA, Sekiya H, Ryan G. Support for an explanation of the guidance effect in motor skill learning. J Mot Behav. 2005 May;37(3):231-8. doi: 10.3200/JMBR.37.3.231-238.

    PubMed 15883120
  • Andriacchi TP, Mundermann A. The role of ambulatory mechanics in the initiation and progression of knee osteoarthritis. Curr Opin Rheumatol. 2006 Sep;18(5):514-8. doi: 10.1097/01.bor.0000240365.16842.4e.

    PubMed 16896293
  • Andriacchi TP, Mundermann A, Smith RL, Alexander EJ, Dyrby CO, Koo S. A framework for the in vivo pathomechanics of osteoarthritis at the knee. Ann Biomed Eng. 2004 Mar;32(3):447-57. doi: 10.1023/b:abme.0000017541.82498.37.

    PubMed 15095819
  • Barrios JA, Crossley KM, Davis IS. Gait retraining to reduce the knee adduction moment through real-time visual feedback of dynamic knee alignment. J Biomech. 2010 Aug 10;43(11):2208-13. doi: 10.1016/j.jbiomech.2010.03.040. Epub 2010 May 8.

    PubMed 20452595
  • Bellamy N, Buchanan WW. A preliminary evaluation of the dimensionality and clinical importance of pain and disability in osteoarthritis of the hip and knee. Clin Rheumatol. 1986 Jun;5(2):231-41. doi: 10.1007/BF02032362.

    PubMed 3731718
  • Bennell KL, Bowles KA, Wang Y, Cicuttini F, Davies-Tuck M, Hinman RS. Higher dynamic medial knee load predicts greater cartilage loss over 12 months in medial knee osteoarthritis. Ann Rheum Dis. 2011 Oct;70(10):1770-4. doi: 10.1136/ard.2010.147082. Epub 2011 Jul 7.

    PubMed 21742637
  • Bernier PM, Chua R, Franks IM. Is proprioception calibrated during visually guided movements? Exp Brain Res. 2005 Nov;167(2):292-6. doi: 10.1007/s00221-005-0063-5. Epub 2005 Nov 15.

    PubMed 16044301
  • Birmingham TB, Hunt MA, Jones IC, Jenkyn TR, Giffin JR. Test-retest reliability of the peak knee adduction moment during walking in patients with medial compartment knee osteoarthritis. Arthritis Rheum. 2007 Aug 15;57(6):1012-7. doi: 10.1002/art.22899.

    PubMed 17665490
  • Butler RJ, Minick KI, Ferber R, Underwood F. Gait mechanics after ACL reconstruction: implications for the early onset of knee osteoarthritis. Br J Sports Med. 2009 May;43(5):366-70. doi: 10.1136/bjsm.2008.052522. Epub 2008 Nov 28.

    PubMed 19042923
  • Chang AH, Moisio KC, Chmiel JS, Eckstein F, Guermazi A, Prasad PV, Zhang Y, Almagor O, Belisle L, Hayes K, Sharma L. External knee adduction and flexion moments during gait and medial tibiofemoral disease progression in knee osteoarthritis. Osteoarthritis Cartilage. 2015 Jul;23(7):1099-106. doi: 10.1016/j.joca.2015.02.005. Epub 2015 Feb 10.

    PubMed 25677110
  • Chang A, Hurwitz D, Dunlop D, Song J, Cahue S, Hayes K, Sharma L. The relationship between toe-out angle during gait and progression of medial tibiofemoral osteoarthritis. Ann Rheum Dis. 2007 Oct;66(10):1271-5. doi: 10.1136/ard.2006.062927. Epub 2007 Jan 31.

    PubMed 17267516
  • Chang JY, Chang GL, Chien CJ, Chung KC, Hsu AT. Effectiveness of two forms of feedback on training of a joint mobilization skill by using a joint translation simulator. Phys Ther. 2007 Apr;87(4):418-30. doi: 10.2522/ptj.20060154. Epub 2007 Mar 6.

    PubMed 17341511
  • Chehab EF, Favre J, Erhart-Hledik JC, Andriacchi TP. Baseline knee adduction and flexion moments during walking are both associated with 5 year cartilage changes in patients with medial knee osteoarthritis. Osteoarthritis Cartilage. 2014 Nov;22(11):1833-9. doi: 10.1016/j.joca.2014.08.009. Epub 2014 Aug 27.

    PubMed 25211281

Questions about this trial

What is this clinical trial studying?

A study testing Foot Progression and Trunk Lean in people with Knee Osteoarthritis, run by George Mason 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 3 inclusion and 6 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 26 Oct 2023. 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 Oladipo Eddo (7039937183, oeddo@gmu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Knee Adduction Moment from Baseline at 10-weeks (time frame: It will be assessed using biomechanical analysis at baseline and 10-weeks gait retraining intervention). 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 NCT03663790, which also lists 88 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 26 Oct 2023.

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