Knee Osteoarthritis Clinical Trial
Official title:
Comparison of the Effects of Gait Modification Strategies on Knee Adduction Moment in Patients With Medial Knee Osteoarthritis: Randomized Controlled Trial
Verified date | October 2023 |
Source | George Mason University |
Contact | Oladipo Eddo |
Phone | 7039937183 |
oeddo[@]gmu.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 51 |
Est. completion date | October 1, 2026 |
Est. primary completion date | October 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Sports Medicine, Assessment, Research & Testing (SMART) Laboratory | Manassas | Virginia |
Lead Sponsor | Collaborator |
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George Mason University |
United States,
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Type | Measure | Description | Time frame | Safety issue |
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Primary | Change from Baseline Knee Adduction Moment from Baseline at 10-weeks | The knee adduction moment is a surrogate measure to evaluate knee joint loads. | It will be assessed using biomechanical analysis at baseline and 10-weeks gait retraining intervention |
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