Recruiting

Gait Retraining

Sponsor:

George Mason University

Code:

NCT03663790

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Foot Progression

Trunk Lean

Study Details

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

Study ID

NCT03663790

Start date

Oct 10, 2018

Status verified date

Oct, 2023

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

51 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

experimental: Trunk Lean

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

Interventions

Foot Progression

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

Trunk Lean

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

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 ]

Central Contacts and Locations

Central contacts

Oladipo Eddo

7039937183oeddo@gmu.edu

Locations

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

Recruiting

Manassas, Virginia, United States, 20110

Principal Investigator:

Oladipo Eddo, PhD

More Information

Sponsor

George Mason University

Last update posted

Oct 26, 2023

Last verified

Oct, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by George Mason University on 2023-10-26.