Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Gait Retraining on Lower Extremity Biomechanics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
George Mason University

Brief 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. 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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
No intervention
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Virginia
Sports Medicine, Assessment, Research & Testing (SMART) Laboratory
Manassas, Virginia, United States, 20110
Sponsors and Collaborators
George Mason University
Investigators
Layout table for investigator information
Principal Investigator: Nelson Cortes Associate Professor
Publications:
Eddo, O., Lindsey, B., Caswell, S. V., & Cortes, N. (2017). Current Evidence of Gait Modification with Real-time Biofeedback to Alter Kinetic, Temporospatial, and Function-Related Outcomes: A Review. International Journal of Kinesiology and Sports Science, 5(3), 35-55.
Shull, P., Lurie, K., Shin, M., Besier, T., & Cutkosky, M. (2010). Haptic gait retraining for knee osteoarthritis treatment. In 2010 IEEE Haptics Symposium (pp. 409-416)

Layout table for additonal information
Responsible Party: George Mason University
ClinicalTrials.gov Identifier: NCT03663790    
Other Study ID Numbers: Gait retraining OA
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by George Mason University:
osteoarthritis
biomechanics
gait retraining
real-time biofeedback
knee
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases