Anterior Cruciate Ligament InjuriesNCT06368544
Effect of Early Gait Training on Knee Cartilage Degeneration After Anterior Cruciate Ligament Reconstruction
A study testing lower-body positive-pressure in people with Anterior Cruciate Ligament Injuries and Cartilage Degeneration, run by Peking University Third Hospital at 1 site in China.
Trial summary
A randomized controlled clinical study was conducted to elucidate the relationship between the lower extremity biomechanics of patients undergoing early gait training after ACLR surgery.The relationship between the biochemical characteristics of cartilage and the biomechanical risk index were proposed to providing… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Cartilage Degeneration
- What is being tested?
- lower-body positive-pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2024to 31 Dec 2027
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with ACL rupture were diagnosed by MRI;
- Unilateral ACL rupture for the first time should be performed in our hospital (Department of Sports Medicine, Peking University Third Hospital)The art of reconstruction;
- Normal BMI range: 18.5-23.9 kg/m2;
- Within 6 months from the trauma;
- The affected knee joint has passed the acute stage, no obvious redness, pain,inflammation, and limited joint motion,basically restore joint motion.
Who cannot join
- BMI<18.5 kg/m2 or BMI≥24 kg/m2);
- There is a history of contralateral lower limb musculoskeletal system injury and surgery;
- ACL injury time > 6 months;
- Outerbridge damage rating Ⅲ and Ⅳ;
- Patients with meniscal tears who are expected to undergo meniscal suture surgery at the time of ACLR surgery;
- Serious injury to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament;
- There is metabolic syndrome (obesity, dyslipidemia, diabetes, etc.), which will involve articular cartilage Epidemic diseases, serious cardiovascular and cerebrovascular diseases, etc.;
- Those who do not want to accept this treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
ren shuang, xixishuang123@126.com
About this study
A randomized controlled clinical study was conducted to elucidate the relationship between the lower extremity biomechanics of patients undergoing early gait training after ACLR surgery.The relationship between the biochemical characteristics of cartilage and the biomechanical risk index were proposed to providing exercise guidance and training for ACLR people and it is suggested that it can prevent and reduce the risk of cartilage degeneration early after operation.
Read the detailed description
In this randomized controlled clinical study, patients with primary unilateral ACL rupture were included. In addition to standardized rehabilitation training content, gait training intervention under weight loss was added to the subjects in the early postoperative period. The control group only received standardized rehabilitation training. Based on motion testing and dynamic analysis, the influence of early postoperative gait training on postoperative gait biomechanical characteristics was explored. And the influence of early cartilage health status; Based on functional MRI, the effects of early postoperative gait training on biochemical parameters of knee tibiofemoral and patellofemoral cartilage were investigated.
- Being tested
- lower-body positive-pressure
- Keywords
- anterior cruciate ligament injuries, gait training, Cartilage biochemical characteristics, anterior cruciate ligament reconstruction
- 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.
lower-body positive-pressureOther
By increasing the chamber in the lower body around Pressure acts as a counterweight to gravity
| Study group | Role | What they receive |
|---|---|---|
| Gait intervention group | Experimental | On the basis of routine standardized rehabilitation procedures, in Early gait intervention training under the condition of weight loss Receives: Other: lower-body positive-pressure |
| Standardized rehabilitation control group | No intervention | Only standardized rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait biomechanical data
Hip, knee and ankle joint angles and moments at the moment of landing and peak ground reaction force.
Measured: from 3 months to 2 years
Gait biomechanical data
The maximum three-dimensional torque of the hip, knee and ankle during the support phase.
Measured: from 3 months to 2 years
Gait biomechanical data
The maximum three-dimensional Angle and range of motion of the hip, knee and ankle joints during the whole gait cycle.
Measured: from 3 months to 2 years
Gait biomechanical data
The symmetry index of Angle and torque of each joint.
Measured: from 3 months to 2 years
Gait biomechanical data
The two groups of joint biomechanics and their gait touch information characteristics
Measured: from 3 months to 2 years
Biochemical characteristics of knee cartilage
T1rho values of different regions of knee cartilage
Measured: from 3 months to 2 years
Biochemical characteristics of knee cartilage
T2 mapping values of different regions of knee cartilage
Measured: from 3 months to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start22 Jul 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ren shuang, doctor, Study chair, Be affiliated with the organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368544
- Sponsor's protocol ID
- M2023816
- Status last verified
- Dec 2024
- First submitted
- 5 Mar 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dang R, Lu Y, Zhou Z, Zhou Z, Cui N, Yu Y, Zhang S, Ao Y, Huang H, Wang J, Ren S. Biomechanical mechanisms of early gait training on knee cartilage degeneration after anterior cruciate ligament reconstruction: a study protocol. Front Sports Act Living. 2026 Jun 24;8:1833258. doi: 10.3389/fspor.2026.1833258. eCollection 2026.
PubMed 42421839
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Gait Training on Knee Cartilage Degeneration After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT06368544
- Acronym / sponsor ID
- M2023816
- Keywords
- anterior cruciate ligament injuries, gait training, Cartilage biochemical characteristics, anterior cruciate ligament reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Apr 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.
A randomized controlled clinical study was conducted to elucidate the relationship between the lower extremity biomechanics of patients undergoing early gait training after ACLR surgery.The relationship between the biochemical characteristics of cartilage and the biomechanical risk index were proposed to providing exercise guidance and training for ACLR people and it is suggested that it can prevent and reduce the risk of cartilage degeneration early after operation.
Detailed description
In this randomized controlled clinical study, patients with primary unilateral ACL rupture were included. In addition to standardized rehabilitation training content, gait training intervention under weight loss was added to the subjects in the early postoperative period. The control group only received standardized rehabilitation training. Based on motion testing and dynamic analysis, the influence of early postoperative gait training on postoperative gait biomechanical characteristics was explored. And the influence of early cartilage health status; Based on functional MRI, the effects of early postoperative gait training on biochemical parameters of knee tibiofemoral and patellofemoral cartilage were investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gait intervention group | Experimental | Other: lower-body positive-pressureOn the basis of routine standardized rehabilitation procedures, in Early gait intervention training under the condition of weight loss |
| Standardized rehabilitation control group | No intervention | –Only standardized rehabilitation training |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with ACL rupture were diagnosed by MRI;
- Unilateral ACL rupture for the first time should be performed in our hospital (Department of Sports Medicine, Peking University Third Hospital)The art of reconstruction;
- Normal BMI range: 18.5-23.9 kg/m2;
- Within 6 months from the trauma;
- The affected knee joint has passed the acute stage, no obvious redness, pain,inflammation, and limited joint motion,basically restore joint motion.
Key exclusion criteria (8 listed)
- BMI<18.5 kg/m2 or BMI≥24 kg/m2);
- There is a history of contralateral lower limb musculoskeletal system injury and surgery;
- ACL injury time > 6 months;
- Outerbridge damage rating Ⅲ and Ⅳ;
- Patients with meniscal tears who are expected to undergo meniscal suture surgery at the time of ACLR surgery;
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 |
|---|---|---|
| lower-body positive-pressureBy increasing the chamber in the lower body around Pressure acts as a counterweight to gravity | Other | Gait intervention group |
Primary outcome
Gait biomechanical data
Time frame: from 3 months to 2 years
Hip, knee and ankle joint angles and moments at the moment of landing and peak ground reaction force.
Gait biomechanical data
Time frame: from 3 months to 2 years
The maximum three-dimensional torque of the hip, knee and ankle during the support phase.
Gait biomechanical data
Time frame: from 3 months to 2 years
The maximum three-dimensional Angle and range of motion of the hip, knee and ankle joints during the whole gait cycle.
Gait biomechanical data
Time frame: from 3 months to 2 years
The symmetry index of Angle and torque of each joint.
Gait biomechanical data
Time frame: from 3 months to 2 years
The two groups of joint biomechanics and their gait touch information characteristics
Biochemical characteristics of knee cartilage
Time frame: from 3 months to 2 years
T1rho values of different regions of knee cartilage
Biochemical characteristics of knee cartilage
Time frame: from 3 months to 2 years
T2 mapping values of different regions of knee cartilage
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 25 Jul 2025.
- Derived from this study: PubMed 42421839Dang R, Lu Y, Zhou Z, Zhou Z, Cui N, Yu Y, Zhang S, Ao Y, Huang H, Wang J, Ren S. Biomechanical mechanisms of early gait training on knee cartilage degeneration after anterior cruciate ligament reconstruction: a study protocol. Front Sports Act Living. 2026 Jun 24;8:1833258. doi: 10.3389/fspor.2026.1833258. eCollection 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Anterior Cruciate Ligament Injuries
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Stair Biomechanics and Vibration Study After ACLR
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
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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.
ren shuang, doctor study chair
Be affiliated with the organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lower-body positive-pressure in people with Anterior Cruciate Ligament Injuries and Cartilage Degeneration, run by Peking University Third Hospital at 1 site in China.
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 5 inclusion and 8 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 25 Jul 2025. 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 China. 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 ren shuang, doctor (17610252992, xixishuang123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait biomechanical data (time frame: from 3 months to 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06368544, which also lists 1 linked publication.
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 25 Jul 2025.