Anterior Cruciate Ligament InjuriesNCT05007366
Optimizing Gait Biomechanics for Posttraumatic Osteoarthritis Prevention
A study testing Real-time gait biofeedback in people with Anterior Cruciate Ligament Injuries and Post-traumatic Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Post-traumatic Osteoarthritis, Knee Osteoarthritis
- What is being tested?
- Real-time gait biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2021to 2 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- ACLR revision surgery
- A multiple ligament surgery
- A lower extremity fracture
- Knee osteoarthritis
- The participant has a BMI ≥ 36.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27516
About this study
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.
- Conditions
- Anterior Cruciate Ligament Injuries, Post-traumatic Osteoarthritis, Knee Osteoarthritis, Knee Injuries, Cartilage, Articular, Gait
- Being tested
- Real-time gait biofeedback, Sham real-time gait biofeedback
- Keywords
- Biofeedback
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Osteoarthritis, Knee, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time gait biofeedbackBehavioural
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 biofeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Real-time gait biofeedback (RTGBF) | Active comparator | The RTGBF regimen delivers biofeedback that cues a personalized target to normalize vertical ground reaction force (vGRF) of each limb. Receives: Behavioral: Real-time gait biofeedback |
| Sham real-time gait biofeedback (Sham RTGBF) | Sham comparator | 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. Receives: Behavioral: Sham real-time gait biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-intervention)
Percentage of participants retained
Investigators will record the percentage of patients retained at each monthly data capture timepoint.
Measured: 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.
Measured: 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
Measured: About 2 months
Secondary outcomes (17)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start5 Aug 2021
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Foundation
- Responsible party
- Sponsor
- Investigators
- Brian Pietrosimone, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007366
- Sponsor's protocol ID
- 21-1489a
- Status last verified
- Apr 2023
- First submitted
- 12 Aug 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Gait Biomechanics for Posttraumatic Osteoarthritis Prevention
- ClinicalTrials.gov ID
- NCT05007366
- Acronym / sponsor ID
- 21-1489a
- Conditions
- Anterior Cruciate Ligament Injuries, Post-traumatic Osteoarthritis, Knee Osteoarthritis, Knee Injuries, Cartilage, Articular, Gait
- Keywords
- Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Arthritis Foundation
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-time gait biofeedback (RTGBF) | Active comparator | Behavioral: Real-time gait biofeedbackThe RTGBF regimen delivers biofeedback that cues a personalized target to normalize vertical ground reaction force (vGRF) of each limb. |
| Sham real-time gait biofeedback (Sham RTGBF) | Sham comparator | Behavioral: Sham real-time gait biofeedbackThe Sham RTGBF regimen will receive biofeedback that cues their habitual step length determined during the accommodation period on the first session of treadmill walking. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- ACLR revision surgery
- A multiple ligament surgery
- A lower extremity fracture
- Knee osteoarthritis
- The participant has a BMI ≥ 36.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time gait biofeedbackThe 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. | Behavioural | Real-time gait biofeedback (RTGBF) |
| Sham real-time gait biofeedbackThe 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. | Behavioural | Sham real-time gait biofeedback (Sham RTGBF) |
Primary outcome
Number of participants recruited using different recruitment modes
Time frame: Baseline (pre-intervention)
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
Time frame: Baseline (pre-intervention)
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
Time frame: Baseline (pre-intervention)
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
Time frame: After week 4 and after week 8
Investigators will record the percentage of patients retained at each monthly data capture timepoint.
Reasons for refusal to enroll
Time frame: Baseline (pre-intervention)
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
Time frame: About 2 months
Percent of subjects who completed the sequence of training sessions and retention sessions. Range: 0-100. Higher percentage indicates more completion
17 secondary outcomes
The change in vertical ground reaction force before and after intervention
Time frame: Up to 2 months
The change in T1ρ MRI relaxation times before and after intervention
Time frame: Up to 2 months
The change in T1ρ MRI relaxation times in the medial femoral condyle before and after intervention
Time frame: Up to 2 months
The change in T1ρ MRI relaxation times in the lateral femoral condyle before and after intervention
Time frame: Up to 2 months
The change in T1ρ MRI relaxation times in the medial tibial condyle before and after intervention
Time frame: Up to 2 months
The change in T1ρ MRI relaxation times in the lateral tibial condyle before and after intervention
Time frame: Up to 2 months
The change in the Knee Injury and Osteoarthritis Outcome Quality of Life subscale score
Time frame: Up to 2 months
The change in the International Knee Documentation Committee Subjective Knee Evaluation form score
Time frame: Up to 2 months
The change in the Tegner Activity Scale score
Time frame: Up to 2 months
The change in the Anterior Cruciate Ligament Return to Sport After Injury Scale score
Time frame: Up to 2 months
The change in the Visual, Aural, Reading/Writing, and Kinesthetic Questionnaire score
Time frame: Up to 2 months
The change in peak vGRF
Time frame: Up to 2 months
The change in peak knee flexion excursion
Time frame: Up to 2 months
The change in peak internal knee extension moment
Time frame: Up to 2 months
The change in joint tissues metabolism by assessing biomarker chemokine (monocyte chemoattractant protein-1 (MCP-1)).
Time frame: Up to 2 months
The change in joint tissues metabolism by assessing degenerative matrix metalloproteinase-3 (MMP-3) enzyme.
Time frame: Up to 2 months
The change in joint tissues metabolism by assessing marker of cartilage turnover (cartilage oligomeric matrix protein (COMP)).
Time frame: Up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Pietrosimone principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time gait biofeedback in people with Anterior Cruciate Ligament Injuries and Post-traumatic Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited using different recruitment modes (time frame: Baseline (pre-intervention)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.