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NCT03663790 · ClinicalTrials.gov registry record · NA
Effects of Gait Retraining on Lower Extremity Biomechanics
A NA study of Knee Osteoarthritis, sponsored by George Mason University.
- Recruiting
- Registry status
- NA
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT03663790 is a NA study of Knee Osteoarthritis that is actively recruiting participants, run by George Mason University. The registered enrollment target is 51 participants, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03663790, a NA study of Knee Osteoarthritis, is actively recruiting participants, sponsored by George Mason University.
- RECRUITING
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study 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 analys
Conditions Studied
Interventions
- OTHER Foot Progression
- OTHER Trunk Lean
Study Locations (1)
Virginia
- Sports Medicine, Assessment, Research & Testing (SMART) Laboratory - Manassas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2018-10-10 |
| Est. Completion | 2026-10-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03663790
The ClinicalTrials.gov registry entry for NCT03663790 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (83% lower). The listed sponsor is George Mason University, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Knee Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which Foot Progression is the first listed.
NCT03663790 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT03663790 about?
NCT03663790 is a clinical study titled "Effects of Gait Retraining on Lower Extremity Biomechanics". 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 re...
What is the current status of trial NCT03663790?
This trial is currently recruiting. It is a NA study. The enrollment target is 51 participants. The study started on 2018-10-10. Estimated completion is 2026-10-01.
What conditions does trial NCT03663790 study?
This clinical trial studies the following conditions: Knee Osteoarthritis.
What interventions are being tested in trial NCT03663790?
The interventions under investigation include: Foot Progression (OTHER), Trunk Lean (OTHER).
Who is sponsoring clinical trial NCT03663790?
This trial is sponsored by George Mason University, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03663790 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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