Anterior Cruciate Ligament InjuriesSTOPNCT06193343
Steps Towards Osteoarthritis Prevention
A study testing Adaptive Daily Step Promotion in people with Anterior Cruciate Ligament Injuries, run by University of Georgia at 1 site in United States.
Trial summary
Optimal knee joint loading, which refers to the forces acting on the knee caused by daily activities such as daily steps, plays an essential role in maintaining knee articular cartilage health and reducing the risk of osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Adaptive Daily Step Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2024to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Provision of signed and dated informed consent form
- For children, signed and dated informed assent by child and parental permission form by parent/guardian to participate in the study
- Underwent an anterior cruciate ligament reconstruction (ACLR) between 6-60 months prior to enrollment
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Completed all other formal physical therapy and therapeutic exercise regimens, and will not be engaging in any other formal therapy for their ACLR during the study
- Physician clearance for unrestricted activity
- Owning a smartphone
- Demonstrate < 8,000 steps per day during the screening phase of aim 2 as assessed using the Actigraph Link monitor
Who cannot join
- Underwent an ACLR revision surgery due to a previous anterior cruciate ligament (ACL) graft injury
- A multiple ligament surgery was indicated with their ACL injury
- A lower extremity fracture was suffered during the ACL injury
- The participant has previously been diagnosed with any diseases that affect joints is present in either knee including knee osteoarthritis inflammatory arthritis
- Pregnant or plans to become pregnant over next 4 months
- Body mass index (BMI) ≥ 36 kg/m2
Show all 12Show fewer
- Unable to speak English
- Cochlear implant
- Metal in body (metal fragments, shrapnel, permanent make-up, body piercings that cannot be removed)
- Claustrophobia
- History of seizures
- Pacemaker
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Georgia
Athens, Georgia, 30602
Caroline Lisee, PhD, 706-542-7137, caroline.lisee@uga.edu
Christopher Modlesky, PhD, 706-542-4424, christopher.modlesky@uga.edu
About this study
Official title: Steps Towards Osteoarthritis Prevention: A Pilot Study
Optimal knee joint loading, which refers to the forces acting on the knee caused by daily activities such as daily steps, plays an essential role in maintaining knee articular cartilage health and reducing the risk of osteoarthritis (OA). After anterior cruciate ligament reconstruction (ACLR), individuals take fewer daily steps as compared to uninjured controls resulting in insufficient knee joint loading to joint tissues, but it is unclear how changes in daily steps impact knee joint cartilage health in OA development. Therefore, the overall single arm, longitudinal pre-test post-test study objective is to determine the mechanistic links between knee joint loading as measured by daily steps and comprehensive magnetic resonance imaging (MRI) measures of knee joint cartilage health post-ACLR. The central hypothesis is that individuals post-ACLR who take low daily steps will demonstrate deconditioned, less resilient cartilage characterized by poor tibiofemoral cartilage composition and greater cartilage strain.
Read the detailed description
Osteoarthritis (OA) is a leading cause of disability. Identifying modifiable mechanisms of poor knee joint health development for disease prevention strategies are critical to improving long-term health. Aberrant mechanical loading has been theorized as a primary risk factor for knee OA. Most studies primarily focus on mechanical mechanisms of excessive joint loading in OA development. However, recent evidence suggests that joint underloading may also play a role. The effects of low loading frequency assessed via daily steps in real world settings on knee joint health is an understudied parameter of aberrant mechanical loading in individuals at risk for OA. Individuals with anterior cruciate ligament (ACL) injury who undergo ACL reconstruction (ACLR) surgery are a representative population to assess the effects of low loading frequency on knee joint health because they are at elevated risk for posttraumatic OA development and demonstrate low daily steps compared to uninjured individuals. Therefore, the overall study objective is to determine the mechanistic links between joint loading frequency and comprehensive magnetic resonance imaging (MRI) measures of knee joint cartilage health in individuals post-ACLR. The central hypothesis is that individuals post-ACLR who take low daily steps will demonstrate deconditioned, less resilient cartilage characterized by poor tibiofemoral cartilage composition and greater cartilage strain which represent equally important, but independent measures of cartilage health. Furthermore, increasing daily steps using a 16-week daily step promotion paradigm in individuals post-ACLR who underload (<8000 daily steps which is predictive of physical inactivity) will recondition cartilage by improving tibiofemoral cartilage composition and strain. The proposed study aims to determine: 1) associations between daily steps with tibiofemoral cartilage composition and strain in ACLR individuals (n=56) using an observational cross-sectional study design, and 2) the effects of increasing daily steps over 16-weeks on tibiofemoral cartilage composition and strain in ACLR individuals with low daily steps (n=28) using a single arm, longitudinal pre-test post-test study design. The proposed study is innovative because it builds on observational studies linking underloading with poor knee joint health and will be the first study to mechanistically determine how altering loading frequency (i.e., increasing daily steps) affects comprehensive in vivo measures of cartilage health in individuals at risk for OA. Successful completion of the proposed study will provide foundational evidence for the development of a future randomized controlled trial to determine the efficacy of an adaptive daily step promotion.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Adaptive Daily Step Promotion
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Daily Step PromotionBehavioural
Participants will wear a Fitbit monitor on their non-dominant wrist during a 10 to 14 day "run-in" screening to capture daily steps reported by the Fitbit but no daily step goals will be sent to the participant. The Fitbit monitor will be worn during all waking hours except water activities, and compliance will be considered as a day with ≥1,000 steps. Next, participants will undergo a 16-week intervention wearing the Fitbit monitor on their wrist and receive a text message each morning with a personalized, adaptive daily step count goal and a link used to confirm receipt of the goal. The preceding 10 days of step data will be rank ordered and the 60th percentile step count will be set as the goal for the next day. Goals will not exceed 10,000 daily steps.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | Participants who meet study criteria and are enrolled in adaptive daily step promotion intervention Receives: Behavioral: Adaptive Daily Step Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
T2 relaxation times in the medial femoral condyle
MRI marker of T2 relaxation times of medial femoral articular cartilage (i.e collagen organization) at pre-intervention (baseline)
Measured: pre-intervention (baseline)
T2 relaxation times in the lateral femoral condyle
MRI marker of T2 relaxation times of lateral femoral articular cartilage (i.e collagen organization) at pre-intervention (baseline)
Measured: pre-intervention (baseline)
T2 relaxation times in the medial tibial condyle
MRI marker of T2 relaxation times of medial tibial articular cartilage (i.e collagen organization) at pre-intervention (baseline)
Measured: pre-intervention (baseline)
T2 relaxation times in the lateral tibial condyle
MRI marker of T2 relaxation times of lateral tibial articular cartilage (i.e collagen organization) at pre-intervention (baseline)
Measured: pre-intervention (baseline)
Change in T2 relaxation times in the medial femoral condyle
Change in MRI marker of T2 relaxation times of medial femoral articular cartilage (i.e collagen organization) from pre-intervention to post-intervention
Measured: pre-intervention (baseline), post-intervention (~18 weeks)
Change in T2 relaxation times in the lateral femoral condyle
Change in MRI marker of T2 relaxation times of lateral femoral articular cartilage (i.e collagen organization) from pre-intervention to post-intervention
Measured: post-intervention (~18 weeks)
Change in T2 relaxation times in the medial tibial condyle
Change in MRI marker of T2 relaxation times of medial tibial articular cartilage (i.e collagen organization) from pre-intervention to post-intervention
Measured: pre-intervention (baseline), post-intervention (~18 weeks)
Change T2 relaxation times in the lateral tibial condyle
Change in MRI marker of T2 relaxation times of lateral tibial articular cartilage (i.e collagen organization) from pre-intervention to post-intervention
Measured: pre-intervention (baseline), post-intervention (~18 weeks)
Average cartilage strain in the medial femoral condyle
MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of medial femoral articular cartilage at pre-intervention (baseline)
Measured: pre-intervention (baseline)
Average cartilage strain in the lateral femoral condyle
MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of lateral femoral articular cartilage at pre-intervention (baseline)
Measured: pre-intervention (baseline)
Average cartilage strain in the medial tibial condyle
MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of medial tibial articular cartilage at pre-intervention (baseline)
Measured: pre-intervention (baseline)
Average cartilage strain in the lateral tibial condyle
MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of lateral tibial articular cartilage at pre-intervention (baseline)
Measured: pre-intervention (baseline)
Change in average cartilage strain in the medial femoral condyle
Change in MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of medial femoral articular cartilage from pre-intervention to post-intervention
Measured: pre-intervention (baseline), post-intervention (~18 weeks)
Change in average cartilage strain in the lateral femoral condyle
Change in MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of lateral femoral articular cartilage from pre-intervention to post-intervention
Measured: pre-intervention (baseline), post-intervention (~18 weeks)
Change in average cartilage strain in the medial tibial condyle
Change in MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of medial tibial articular cartilage from pre-intervention to post-intervention
Measured: pre-intervention (baseline), post-intervention (~18 weeks)
Change in average cartilage strain in the lateral tibial condyle
Change in MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of lateral tibial articular cartilage from pre-intervention to post-intervention
Measured: pre-intervention (baseline), post-intervention (~18 weeks)
Daily steps
Average steps per day over 7 day physical activity monitor wear at pre-intervention (baseline)
Measured: Pre-intervention (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start23 Sep 2024
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jan 2028 (estimated)
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm, longitudinal pre-test post-test study design
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Caroline Lisee, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193343
- Sponsor's protocol ID
- PROJECT00008276
- Other IDs
- K01AR082421
- Acronym
- STOP
- Status last verified
- Apr 2026
- First submitted
- 21 Dec 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of the of the proposed projects, the overall data set will include outcome measures including: * Participant demographics * Knee injury history * ACLR surgical procedure data * Patient reported outcomes of self-reported knee function, physical activity, and psychological recovery * Daily steps throughout the intervention using a Fitbit * Daily steps before and after the intervention using a research grade tri-axial accelerometer * Habitual gait speed * Gait biomechanics at habitual gait speed * Magnetic resonance imaging (i.e., T1ρ, T2, and Dess)) of the tibiofemoral and patellofemoral joint All of the information will be linked together, but deidentified. The data will be available to those who submit a formal written request to the PI and commit to only using the data for researcher purposes unplanned by the investigators. The data cannot be used to recruit or contact participants and must be destroyed or returned following the data analysis.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steps Towards Osteoarthritis Prevention: A Pilot Study
- ClinicalTrials.gov ID
- NCT06193343
- Acronym / sponsor ID
- STOP / PROJECT00008276
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 5 Jan 2024 (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.
Optimal knee joint loading, which refers to the forces acting on the knee caused by daily activities such as daily steps, plays an essential role in maintaining knee articular cartilage health and reducing the risk of osteoarthritis (OA). After anterior cruciate ligament reconstruction (ACLR), individuals take fewer daily steps as compared to uninjured controls resulting in insufficient knee joint loading to joint tissues, but it is unclear how changes in daily steps impact knee joint cartilage health in OA development. Therefore, the overall single arm, longitudinal pre-test post-test study objective is to determine the mechanistic links between knee joint loading as measured by daily steps and comprehensive magnetic resonance imaging (MRI) measures of knee joint cartilage health post-ACLR. The central hypothesis is that individuals post-ACLR who take low daily steps will demonstrate deconditioned, less resilient cartilage characterized by poor tibiofemoral cartilage composition and greater cartilage strain.
Detailed description
Osteoarthritis (OA) is a leading cause of disability. Identifying modifiable mechanisms of poor knee joint health development for disease prevention strategies are critical to improving long-term health. Aberrant mechanical loading has been theorized as a primary risk factor for knee OA. Most studies primarily focus on mechanical mechanisms of excessive joint loading in OA development. However, recent evidence suggests that joint underloading may also play a role. The effects of low loading frequency assessed via daily steps in real world settings on knee joint health is an understudied parameter of aberrant mechanical loading in individuals at risk for OA. Individuals with anterior cruciate ligament (ACL) injury who undergo ACL reconstruction (ACLR) surgery are a representative population to assess the effects of low loading frequency on knee joint health because they are at elevated risk for posttraumatic OA development and demonstrate low daily steps compared to uninjured individuals. Therefore, the overall study objective is to determine the mechanistic links between joint loading frequency and comprehensive magnetic resonance imaging (MRI) measures of knee joint cartilage health in individuals post-ACLR. The central hypothesis is that individuals post-ACLR who take low daily steps will demonstrate deconditioned, less resilient cartilage characterized by poor tibiofemoral cartilage composition and greater cartilage strain which represent equally important, but independent measures of cartilage health. Furthermore, increasing daily steps using a 16-week daily step promotion paradigm in individuals post-ACLR who underload (<8000 daily steps which is predictive of physical inactivity) will recondition cartilage by improving tibiofemoral cartilage composition and strain. The proposed study aims to determine: 1) associations between daily steps with tibiofemoral cartilage composition and strain in ACLR individuals (n=56) using an observational cross-sectional study design, and 2) the effects of increasing daily steps over 16-weeks on tibiofemoral cartilage composition and strain in ACLR individuals with low daily steps (n=28) using a single arm, longitudinal pre-test post-test study design. The proposed study is innovative because it builds on observational studies linking underloading with poor knee joint health and will be the first study to mechanistically determine how altering loading frequency (i.e., increasing daily steps) affects comprehensive in vivo measures of cartilage health in individuals at risk for OA. Successful completion of the proposed study will provide foundational evidence for the development of a future randomized controlled trial to determine the efficacy of an adaptive daily step promotion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm, longitudinal pre-test post-test study design
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Behavioral: Adaptive Daily Step PromotionParticipants who meet study criteria and are enrolled in adaptive daily step promotion intervention |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form
- For children, signed and dated informed assent by child and parental permission form by parent/guardian to participate in the study
- Underwent an anterior cruciate ligament reconstruction (ACLR) between 6-60 months prior to enrollment
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Completed all other formal physical therapy and therapeutic exercise regimens, and will not be engaging in any other formal therapy for their ACLR during the study
Key exclusion criteria (12 listed)
- Underwent an ACLR revision surgery due to a previous anterior cruciate ligament (ACL) graft injury
- A multiple ligament surgery was indicated with their ACL injury
- A lower extremity fracture was suffered during the ACL injury
- The participant has previously been diagnosed with any diseases that affect joints is present in either knee including knee osteoarthritis inflammatory arthritis
- Pregnant or plans to become pregnant over next 4 months
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 |
|---|---|---|
| Adaptive Daily Step PromotionParticipants will wear a Fitbit monitor on their non-dominant wrist during a 10 to 14 day "run-in" screening to capture daily steps reported by the Fitbit but no daily step goals will be sent to the participant. The Fitbit monitor will be worn during all waking hours except water activities, and compliance will be considered as a day with ≥1,000 steps. Next, participants will undergo a 16-week intervention wearing the Fitbit monitor on their wrist and receive a text message each morning with a personalized, adaptive daily step count goal and a link used to confirm receipt of the goal. The preceding 10 days of step data will be rank ordered and the 60th percentile step count will be set as the goal for the next day. Goals will not exceed 10,000 daily steps. | Behavioural | Interventional Group |
Primary outcome
T2 relaxation times in the medial femoral condyle
Time frame: pre-intervention (baseline)
MRI marker of T2 relaxation times of medial femoral articular cartilage (i.e collagen organization) at pre-intervention (baseline)
T2 relaxation times in the lateral femoral condyle
Time frame: pre-intervention (baseline)
MRI marker of T2 relaxation times of lateral femoral articular cartilage (i.e collagen organization) at pre-intervention (baseline)
T2 relaxation times in the medial tibial condyle
Time frame: pre-intervention (baseline)
MRI marker of T2 relaxation times of medial tibial articular cartilage (i.e collagen organization) at pre-intervention (baseline)
T2 relaxation times in the lateral tibial condyle
Time frame: pre-intervention (baseline)
MRI marker of T2 relaxation times of lateral tibial articular cartilage (i.e collagen organization) at pre-intervention (baseline)
Change in T2 relaxation times in the medial femoral condyle
Time frame: pre-intervention (baseline), post-intervention (~18 weeks)
Change in MRI marker of T2 relaxation times of medial femoral articular cartilage (i.e collagen organization) from pre-intervention to post-intervention
Change in T2 relaxation times in the lateral femoral condyle
Time frame: post-intervention (~18 weeks)
Change in MRI marker of T2 relaxation times of lateral femoral articular cartilage (i.e collagen organization) from pre-intervention to post-intervention
Change in T2 relaxation times in the medial tibial condyle
Time frame: pre-intervention (baseline), post-intervention (~18 weeks)
Change in MRI marker of T2 relaxation times of medial tibial articular cartilage (i.e collagen organization) from pre-intervention to post-intervention
Change T2 relaxation times in the lateral tibial condyle
Time frame: pre-intervention (baseline), post-intervention (~18 weeks)
Change in MRI marker of T2 relaxation times of lateral tibial articular cartilage (i.e collagen organization) from pre-intervention to post-intervention
Average cartilage strain in the medial femoral condyle
Time frame: pre-intervention (baseline)
MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of medial femoral articular cartilage at pre-intervention (baseline)
Average cartilage strain in the lateral femoral condyle
Time frame: pre-intervention (baseline)
MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of lateral femoral articular cartilage at pre-intervention (baseline)
Average cartilage strain in the medial tibial condyle
Time frame: pre-intervention (baseline)
MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of medial tibial articular cartilage at pre-intervention (baseline)
Average cartilage strain in the lateral tibial condyle
Time frame: pre-intervention (baseline)
MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of lateral tibial articular cartilage at pre-intervention (baseline)
Change in average cartilage strain in the medial femoral condyle
Time frame: pre-intervention (baseline), post-intervention (~18 weeks)
Change in MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of medial femoral articular cartilage from pre-intervention to post-intervention
Change in average cartilage strain in the lateral femoral condyle
Time frame: pre-intervention (baseline), post-intervention (~18 weeks)
Change in MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of lateral femoral articular cartilage from pre-intervention to post-intervention
Change in average cartilage strain in the medial tibial condyle
Time frame: pre-intervention (baseline), post-intervention (~18 weeks)
Change in MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of medial tibial articular cartilage from pre-intervention to post-intervention
Change in average cartilage strain in the lateral tibial condyle
Time frame: pre-intervention (baseline), post-intervention (~18 weeks)
Change in MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of lateral tibial articular cartilage from pre-intervention to post-intervention
Daily steps
Time frame: Pre-intervention (baseline)
Average steps per day over 7 day physical activity monitor wear at pre-intervention (baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Yes. Upon completion of the of the proposed projects, the overall data set will include outcome measures including: * Participant demographics * Knee injury history * ACLR surgical procedure data * Patient reported outcomes of self-reported knee function, physical activity, and psychological recovery * Daily steps throughout the intervention using a Fitbit * Daily steps before and after the intervention using a research grade tri-axial accelerometer * Habitual gait speed * Gait biomechanics at habitual gait speed * Magnetic resonance imaging (i.e., T1ρ, T2, and Dess)) of the tibiofemoral and patellofemoral joint All of the information will be linked together, but deidentified. The data will be available to those who submit a formal written request to the PI and commit to only using the data for researcher purposes unplanned by the investigators. The data cannot be used to recruit or contact participants and must be destroyed or returned following the data analysis.
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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.
Caroline Lisee, PhD principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Daily Step Promotion in people with Anterior Cruciate Ligament Injuries, run by University of Georgia 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 8 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Lisee, PhD (706-542-7137, caroline.lisee@uga.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T2 relaxation times in the medial femoral condyle (time frame: pre-intervention (baseline)). The study lists 17 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 29 Apr 2026.