Optimizing Gait Biomechanics for Posttraumatic Osteoarthritis Prevention

Knee Osteoarthritis Clinical Trial

Official title:

Optimizing Gait Biomechanics for Posttraumatic Osteoarthritis Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05007366
• Other study ID #: 21-1489a
• Status: Completed
• Phase: N/A
• Start date: August 5, 2021
• Est. completion date: December 2, 2022

Study information

• Verified date: April 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2, 2022
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Cartilage, Articular
• Gait
• Knee Injuries
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Post-traumatic Osteoarthritis
• Wounds and Injuries

Intervention

Behavioral:
• Real-time gait biofeedback
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.
• Sham real-time gait biofeedback
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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Arthritis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (pre-intervention)
Primary	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.	Baseline (pre-intervention)
Primary	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.	Baseline (pre-intervention)
Primary	Percentage of participants retained	Investigators will record the percentage of patients retained at each monthly data capture timepoint.	After week 4 and after week 8
Primary	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.	Baseline (pre-intervention)
Primary	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	About 2 months
Secondary	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	Up to 2 months
Secondary	The change in T1? MRI relaxation times before and after intervention	MRI imaging provided cartilage compositions that were used to measure T1? relaxation times. The T1? 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.	Up to 2 months
Secondary	The change in T1? 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.	Up to 2 months
Secondary	The change in T1? 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.	Up to 2 months
Secondary	The change in T1? 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.	Up to 2 months
Secondary	The change in T1? 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.	Up to 2 months
Secondary	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.	Up to 2 months
Secondary	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.	Up to 2 months
Secondary	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.	Up to 2 months
Secondary	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.	Up to 2 months
Secondary	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.	Up to 2 months
Secondary	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.	Up to 2 months
Secondary	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.	Up to 2 months
Secondary	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.	Up to 2 months
Secondary	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.	Up to 2 months
Secondary	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.	Up to 2 months
Secondary	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.	Up to 2 months