Effects of Gait Retraining on Lower Extremity Biomechanics

NCT03663790 | Recruiting

• 1 other identifier: Gait retraining OA
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

osteoarthritis; biomechanics; gait retraining; real-time biofeedback; knee

Outcome Measures

Primary Outcomes (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.

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

Study Arms (3)

Control

NO INTERVENTION

No intervention

Foot Progression

EXPERIMENTAL

Participants will visualize a desired foot progression angle bandwidth in real-time that they should target with their foot angle

Other: Foot Progression

Trunk Lean

EXPERIMENTAL

Participants will visualize a desired trunk lean angle bandwidth in real-time that they should target with their trunk lean angle

Other: Trunk Lean

Interventions

Foot Progression OTHER

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

Foot Progression

Trunk Lean OTHER

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

Trunk Lean

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• George Mason University: lead

Study Sites (1)

Sports Medicine, Assessment, Research & Testing (SMART) Laboratory

Manassas, Virginia, 20110, United States

RECRUITING

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MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Nelson Cortes

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oladipo Eddo

CONTACT

7039937183; oeddo@gmu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 10, 2018
• Study Start: October 10, 2018
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)