Effects of Gait Retraining on Lower Extremity Biomechanics
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|ClinicalTrials.gov Identifier: NCT03663790|
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and expected to resume. This is not a suspension of IRB approval.)
First Posted : September 10, 2018
Last Update Posted : July 22, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Other: Foot Progression Other: Trunk Lean||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||51 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of the Effects of Gait Modification Strategies on Knee Adduction Moment in Patients With Medial Knee Osteoarthritis: Randomized Controlled Trial|
|Actual Study Start Date :||October 10, 2018|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||October 1, 2023|
No Intervention: Control
Experimental: Foot Progression
Participants will visualize a desired foot progression angle bandwidth in real-time that they should target with their foot angle
Other: Foot Progression
The intervention will be a gait retraining biofeedback focused on foot angle during gait trials
Experimental: Trunk Lean
Participants will visualize a desired trunk lean angle bandwidth in real-time that they should target with their trunk lean angle
Other: Trunk Lean
The intervention will be a gait retraining biofeedback focused on trunk lean angle during gait trials
- 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 ]The knee adduction moment is a surrogate measure to evaluate knee joint loads.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663790
|United States, Virginia|
|Sports Medicine, Assessment, Research & Testing (SMART) Laboratory|
|Manassas, Virginia, United States, 20110|
|Principal Investigator:||Nelson Cortes||Associate Professor|