NCT06368544

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Jul 2024Dec 2027

First Submitted

Initial submission to the registry

March 5, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 22, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

July 25, 2025

Status Verified

December 1, 2024

Enrollment Period

3.4 years

First QC Date

March 5, 2024

Last Update Submit

July 22, 2025

Conditions

Anterior Cruciate Ligament InjuriesCartilage Degeneration

Keywords

anterior cruciate ligament injuriesgait trainingCartilage biochemical characteristicsanterior cruciate ligament reconstruction

Outcome Measures

Primary Outcomes (7)

  • Gait biomechanical data

    Hip, knee and ankle joint angles and moments at the moment of landing and peak ground reaction force.

    from 3 months to 2 years

  • Gait biomechanical data

    The maximum three-dimensional torque of the hip, knee and ankle during the support phase.

    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.

    from 3 months to 2 years

  • Gait biomechanical data

    The symmetry index of Angle and torque of each joint.

    from 3 months to 2 years

  • Gait biomechanical data

    The two groups of joint biomechanics and their gait touch information characteristics

    from 3 months to 2 years

  • Biochemical characteristics of knee cartilage

    T1rho values of different regions of knee cartilage

    from 3 months to 2 years

  • Biochemical characteristics of knee cartilage

    T2 mapping values of different regions of knee cartilage

    from 3 months to 2 years

Study Arms (2)

Gait intervention group

EXPERIMENTAL

On the basis of routine standardized rehabilitation procedures, in Early gait intervention training under the condition of weight loss

Other: lower-body positive-pressure

Standardized rehabilitation control group

NO INTERVENTION

Only standardized rehabilitation training

Interventions

lower-body positive-pressureOTHER

By increasing the chamber in the lower body around Pressure acts as a counterweight to gravity

Gait intervention group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • ren shuang, doctor

    Be affiliated with the organization

    STUDY CHAIR

Central Study Contacts

ren shuang, doctor

CONTACT

17610252992xixishuang123@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2024

First Posted

April 16, 2024

Study Start

July 22, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

July 25, 2025

Record last verified: 2024-12

Locations

CN(1)