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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
24
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.
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.
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
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.
Time frame: Baseline (pre-intervention)
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.
Time frame: Baseline (pre-intervention)
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.
Time frame: Baseline (pre-intervention)
Percentage of participants retained
Investigators will record the percentage of patients retained at each monthly data capture timepoint.
Time frame: After week 4 and after week 8
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.
Time frame: Baseline (pre-intervention)
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
Time frame: About 2 months
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
Time frame: Up to 2 months
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.
Time frame: Up to 2 months
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.
Time frame: Up to 2 months
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.
Time frame: Up to 2 months
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.
Time frame: Up to 2 months
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.
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Time frame: Up to 2 months
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.
Time frame: Up to 2 months
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.
Time frame: Up to 2 months
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.
Time frame: Up to 2 months
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.
Time frame: Up to 2 months
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.
Time frame: Up to 2 months
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.
Time frame: Up to 2 months
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.
Time frame: Up to 2 months
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.
Time frame: Up to 2 months
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.
Time frame: Up to 2 months
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.
Time frame: Up to 2 months
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.
Time frame: Up to 2 months