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Optimizing Gait Biomechanics for Posttraumatic Osteoarthritis Prevention

Primary Purpose

Anterior Cruciate Ligament Injuries, Post-traumatic Osteoarthritis, Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Real-time gait biofeedback
Sham real-time gait biofeedback
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anterior Cruciate Ligament Injuries focused on measuring Biofeedback

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have completed all other formal physical therapy
  • Are between the ages of 18 and 35
  • Underwent an ACLR between 6 and 24 months prior to enrollment.
  • Demonstrate underloading during gait (vGRF- impact peak <1.09 x BW)
  • Demonstrate clinically relevant-knee symptoms (KOOS-QOL <72)
  • Have undergone ACLR surgery

Exclusion Criteria:

  • ACLR revision surgery
  • A multiple ligament surgery
  • A lower extremity fracture
  • Knee osteoarthritis
  • The participant has a BMI ≥ 36.

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Real-time gait biofeedback (RTGBF)

Sham real-time gait biofeedback (Sham RTGBF)

Arm Description

The RTGBF regimen delivers biofeedback that cues a personalized target to normalize vertical ground reaction force (vGRF) of each limb.

The Sham RTGBF regimen will receive biofeedback that cues their habitual step length determined during the accommodation period on the first session of treadmill walking.

Outcomes

Primary Outcome Measures

Number of participants recruited using different recruitment modes
The investigators will record the number of participants who were recruited, the frequency at which they were recruited, and where they were recruited from. Range 0-70. Higher number indicates more completion.
The frequency of participant recruitment using different recruitment modes
The investigators will record the number of participants who were recruited, the frequency at which they were recruited, and where they were recruited from. Range 0-70. Higher number indicates more completion.
Percentage of participants who were successfully enrolled
The investigators will record the number of participants who were successfully enrolled compared to the total number of participants screened. Range: 0-100. Higher percentage indicates more enrollment.
Percentage of participants retained
Investigators will record the percentage of patients retained at each monthly data capture timepoint.
Reasons for refusal to enroll
Investigators will record the reasons participants opt not to enroll in the study to determine whether there is a trend.
Number of subjects who adhered to the intervention
Percent of subjects who completed the sequence of training sessions and retention sessions. Range: 0-100. Higher percentage indicates more completion

Secondary Outcome Measures

The change in vertical ground reaction force before and after intervention
Participants walked on a dual-belt force-sensing treadmill for 3000 steps while vertical ground reaction forces were collected. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest. An increase in vertical ground reaction force at weeks 6 and 8 from baseline indicates improved gait mechanics
The change in T1ρ MRI relaxation times before and after intervention
MRI imaging provided cartilage compositions that were used to measure T1ρ relaxation times. The T1ρ MRI relaxation times refer to the proteoglycan density within the tibial and femoral cartilage. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest. Lower T1rho relaxation times reflects a better outcome.
The change in T1ρ MRI relaxation times in the medial femoral condyle before and after intervention
MRI marker of T1rho relaxation times of medial femoral articular cartilage (i.e proteoglycan density). This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
The change in T1ρ MRI relaxation times in the lateral femoral condyle before and after intervention
MRI marker of T1rho relaxation times of lateral femoral articular cartilage (i.e proteoglycan density). This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
The change in T1ρ MRI relaxation times in the medial tibial condyle before and after intervention
MRI marker of T1rho relaxation times of medial tibial articular cartilage (i.e proteoglycan density). This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
The change in T1ρ MRI relaxation times in the lateral tibial condyle before and after intervention
MRI marker of T1rho relaxation times of lateral tibial articular cartilage (i.e proteoglycan density). This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
The change in the Knee Injury and Osteoarthritis Outcome Quality of Life subscale score
Knee injury Osteoarthritis Outcome Score (KOOS) Quality of Life subscale to measure knee-related quality of life at pre-intervention (baseline). This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest. A higher score indicates better knee-related quality of life. Range: 0-100.
The change in the International Knee Documentation Committee Subjective Knee Evaluation form score
The International Knee Documentation Committee (IKDC) Subjective Knee Evaluation form is a 10-item survey that determines patient-reported knee-related function. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest. A higher score indicates better knee function. Range: 0-100.
The change in the Tegner Activity Scale score
The Tegner Activity Scale (TAS) to quantify activity levels in individuals with ACL injury on an 11-point Likert scale. A higher score indicates a higher level of activity (e.g., a 10 indicates participants compete in professional or collegiate levels of sport on a regular basis while a 0 indicates indicates that participants are unable to complete any sport or recreational activity due to disability). This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
The change in the Anterior Cruciate Ligament Return to Sport After Injury Scale score
The Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) scale to measure an individual's psychological readiness to return to sport. Range: 0-100 points. A lower score on this questionnaire indicates poorer psychological readiness. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
The change in the Visual, Aural, Reading/Writing, and Kinesthetic Questionnaire score
The Visual, Aural, Reading/Writing, and Kinesthetic (VARK) Questionnaire to quantify a participant's preferred learning styles from four learning styles (Visual, Aural, Reading/Writing, and Kinesthetic). Range: 0-16 for each learning style. Higher scores in one learning style indicates the participant's preferred learning style. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
The change in peak vGRF
Gait biomechanics collected using an eight camera three-dimensional motion analysis system while participants walk on a dual-belt, force-sensing treadmill will be used to quantify peak vGRF. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
The change in peak knee flexion excursion
Gait biomechanics collected using an eight camera three-dimensional motion analysis system while participants walk on a dual-belt, force-sensing treadmill will be used to quantify peak knee flexion excursion. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
The change in peak internal knee extension moment
Gait biomechanics collected using an eight camera three-dimensional motion analysis system while participants walk on a dual-belt, force-sensing treadmill will be used to quantify peak internal knee extension moment. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
The change in joint tissues metabolism by assessing biomarker chemokine (monocyte chemoattractant protein-1 (MCP-1)).
Blood for serum-based biomarker chemokine (monocyte chemoattractant protein-1 (MCP-1)). This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
The change in joint tissues metabolism by assessing degenerative matrix metalloproteinase-3 (MMP-3) enzyme.
Blood for serum-based biomarker degenerative matrix metalloproteinase-3 (MMP-3) enzyme. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
The change in joint tissues metabolism by assessing marker of cartilage turnover (cartilage oligomeric matrix protein (COMP)).
Blood for serum-based biomarker marker of cartilage turnover (cartilage oligomeric matrix protein (COMP)). This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.

Full Information

First Posted
August 12, 2021
Last Updated
April 14, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Arthritis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05007366
Brief Title
Optimizing Gait Biomechanics for Posttraumatic Osteoarthritis Prevention
Official Title
Optimizing Gait Biomechanics for Posttraumatic Osteoarthritis Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 5, 2021 (Actual)
Primary Completion Date
December 2, 2022 (Actual)
Study Completion Date
December 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Arthritis Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to report the feasibility and determine the initial effects of 18 sessions of real-time gait biofeedback delivered over a 6-week period on retention and transfer of normalized gait biomechanics and improvements in indicators of early post-traumatic osteoarthritis development in those with an anterior cruciate ligament reconstruction (ACLR) at 6 and 8-week posttests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Post-traumatic Osteoarthritis, Knee Osteoarthritis, Knee Injuries, Cartilage, Articular, Gait
Keywords
Biofeedback

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real-time gait biofeedback (RTGBF)
Arm Type
Active Comparator
Arm Description
The RTGBF regimen delivers biofeedback that cues a personalized target to normalize vertical ground reaction force (vGRF) of each limb.
Arm Title
Sham real-time gait biofeedback (Sham RTGBF)
Arm Type
Sham Comparator
Arm Description
The Sham RTGBF regimen will receive biofeedback that cues their habitual step length determined during the accommodation period on the first session of treadmill walking.
Intervention Type
Behavioral
Intervention Name(s)
Real-time gait biofeedback
Intervention Description
The RTGBF interventions will include eighteen step gait training sessions. The intervention will gradually increase to 3,000 steps at the 9th and 10th session with 100% feedback. During the remaining sessions, the intervention will include 3,000 steps, but the feedback will be gradually tapered off starting with the 11th session.
Intervention Type
Behavioral
Intervention Name(s)
Sham real-time gait biofeedback
Intervention Description
The Sham RTGBF interventions will include eighteen step gait training sessions. The intervention will gradually increase to 3,000 steps at the 9th and 10th session with 100% feedback. During the remaining sessions, the intervention will include 3,000 steps, but the feedback will be gradually tapered off starting with the 11th session.
Primary Outcome Measure Information:
Title
Number of participants recruited using different recruitment modes
Description
The investigators will record the number of participants who were recruited, the frequency at which they were recruited, and where they were recruited from. Range 0-70. Higher number indicates more completion.
Time Frame
Baseline (pre-intervention)
Title
The frequency of participant recruitment using different recruitment modes
Description
The investigators will record the number of participants who were recruited, the frequency at which they were recruited, and where they were recruited from. Range 0-70. Higher number indicates more completion.
Time Frame
Baseline (pre-intervention)
Title
Percentage of participants who were successfully enrolled
Description
The investigators will record the number of participants who were successfully enrolled compared to the total number of participants screened. Range: 0-100. Higher percentage indicates more enrollment.
Time Frame
Baseline (pre-intervention)
Title
Percentage of participants retained
Description
Investigators will record the percentage of patients retained at each monthly data capture timepoint.
Time Frame
After week 4 and after week 8
Title
Reasons for refusal to enroll
Description
Investigators will record the reasons participants opt not to enroll in the study to determine whether there is a trend.
Time Frame
Baseline (pre-intervention)
Title
Number of subjects who adhered to the intervention
Description
Percent of subjects who completed the sequence of training sessions and retention sessions. Range: 0-100. Higher percentage indicates more completion
Time Frame
About 2 months
Secondary Outcome Measure Information:
Title
The change in vertical ground reaction force before and after intervention
Description
Participants walked on a dual-belt force-sensing treadmill for 3000 steps while vertical ground reaction forces were collected. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest. An increase in vertical ground reaction force at weeks 6 and 8 from baseline indicates improved gait mechanics
Time Frame
Up to 2 months
Title
The change in T1ρ MRI relaxation times before and after intervention
Description
MRI imaging provided cartilage compositions that were used to measure T1ρ relaxation times. The T1ρ MRI relaxation times refer to the proteoglycan density within the tibial and femoral cartilage. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest. Lower T1rho relaxation times reflects a better outcome.
Time Frame
Up to 2 months
Title
The change in T1ρ MRI relaxation times in the medial femoral condyle before and after intervention
Description
MRI marker of T1rho relaxation times of medial femoral articular cartilage (i.e proteoglycan density). This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
Time Frame
Up to 2 months
Title
The change in T1ρ MRI relaxation times in the lateral femoral condyle before and after intervention
Description
MRI marker of T1rho relaxation times of lateral femoral articular cartilage (i.e proteoglycan density). This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
Time Frame
Up to 2 months
Title
The change in T1ρ MRI relaxation times in the medial tibial condyle before and after intervention
Description
MRI marker of T1rho relaxation times of medial tibial articular cartilage (i.e proteoglycan density). This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
Time Frame
Up to 2 months
Title
The change in T1ρ MRI relaxation times in the lateral tibial condyle before and after intervention
Description
MRI marker of T1rho relaxation times of lateral tibial articular cartilage (i.e proteoglycan density). This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
Time Frame
Up to 2 months
Title
The change in the Knee Injury and Osteoarthritis Outcome Quality of Life subscale score
Description
Knee injury Osteoarthritis Outcome Score (KOOS) Quality of Life subscale to measure knee-related quality of life at pre-intervention (baseline). This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest. A higher score indicates better knee-related quality of life. Range: 0-100.
Time Frame
Up to 2 months
Title
The change in the International Knee Documentation Committee Subjective Knee Evaluation form score
Description
The International Knee Documentation Committee (IKDC) Subjective Knee Evaluation form is a 10-item survey that determines patient-reported knee-related function. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest. A higher score indicates better knee function. Range: 0-100.
Time Frame
Up to 2 months
Title
The change in the Tegner Activity Scale score
Description
The Tegner Activity Scale (TAS) to quantify activity levels in individuals with ACL injury on an 11-point Likert scale. A higher score indicates a higher level of activity (e.g., a 10 indicates participants compete in professional or collegiate levels of sport on a regular basis while a 0 indicates indicates that participants are unable to complete any sport or recreational activity due to disability). This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
Time Frame
Up to 2 months
Title
The change in the Anterior Cruciate Ligament Return to Sport After Injury Scale score
Description
The Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) scale to measure an individual's psychological readiness to return to sport. Range: 0-100 points. A lower score on this questionnaire indicates poorer psychological readiness. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
Time Frame
Up to 2 months
Title
The change in the Visual, Aural, Reading/Writing, and Kinesthetic Questionnaire score
Description
The Visual, Aural, Reading/Writing, and Kinesthetic (VARK) Questionnaire to quantify a participant's preferred learning styles from four learning styles (Visual, Aural, Reading/Writing, and Kinesthetic). Range: 0-16 for each learning style. Higher scores in one learning style indicates the participant's preferred learning style. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
Time Frame
Up to 2 months
Title
The change in peak vGRF
Description
Gait biomechanics collected using an eight camera three-dimensional motion analysis system while participants walk on a dual-belt, force-sensing treadmill will be used to quantify peak vGRF. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
Time Frame
Up to 2 months
Title
The change in peak knee flexion excursion
Description
Gait biomechanics collected using an eight camera three-dimensional motion analysis system while participants walk on a dual-belt, force-sensing treadmill will be used to quantify peak knee flexion excursion. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
Time Frame
Up to 2 months
Title
The change in peak internal knee extension moment
Description
Gait biomechanics collected using an eight camera three-dimensional motion analysis system while participants walk on a dual-belt, force-sensing treadmill will be used to quantify peak internal knee extension moment. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
Time Frame
Up to 2 months
Title
The change in joint tissues metabolism by assessing biomarker chemokine (monocyte chemoattractant protein-1 (MCP-1)).
Description
Blood for serum-based biomarker chemokine (monocyte chemoattractant protein-1 (MCP-1)). This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
Time Frame
Up to 2 months
Title
The change in joint tissues metabolism by assessing degenerative matrix metalloproteinase-3 (MMP-3) enzyme.
Description
Blood for serum-based biomarker degenerative matrix metalloproteinase-3 (MMP-3) enzyme. This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
Time Frame
Up to 2 months
Title
The change in joint tissues metabolism by assessing marker of cartilage turnover (cartilage oligomeric matrix protein (COMP)).
Description
Blood for serum-based biomarker marker of cartilage turnover (cartilage oligomeric matrix protein (COMP)). This will be collected at Baseline (pre-intervention), Week 6 posttest, and Week 8 posttest.
Time Frame
Up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have completed all other formal physical therapy Are between the ages of 18 and 35 Underwent an ACLR between 6 and 24 months prior to enrollment. Demonstrate underloading during gait (vGRF- impact peak <1.09 x BW) Demonstrate clinically relevant-knee symptoms (KOOS-QOL <72) Have undergone ACLR surgery Exclusion Criteria: ACLR revision surgery A multiple ligament surgery A lower extremity fracture Knee osteoarthritis The participant has a BMI ≥ 36.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Pietrosimone
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD Sharing Time Frame
9 to 36 months
IPD Sharing Access Criteria
The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

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Optimizing Gait Biomechanics for Posttraumatic Osteoarthritis Prevention

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