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Effects of Preoperative Rehabilitation on Tendon Healing and Bone Mineral Density After ACLR

Primary Purpose

Anterior Cruciate Ligament Rupture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exercise rehablitation
routine treatment
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18~40 years old, diagnosed ACL rupture by MRI; The first unilateral ACL rupture requires reconstruction at our hospital; Greater than 6 weeks from trauma and within 6 months. Exclusion Criteria: Be older than 40 years, or less than 18 years old Within 8 weeks of the onset of the trauma, or more than 1 year Severe injury to other knee ligaments History of knee trauma

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    experimental group

    control group

    Arm Description

    Before ACL reconstruction,40 minutes of rehabilitation training was performed 3 times a week for 6 weeks, and gotted regular treatment. The ACL reconstruction was followed by a 0.5 year rehabilitation.

    Regular rehabilitation training was not performed before ACL reconstruction, got regular treatment. The ACL reconstruction was followed by a 0.5 year rehabilitation.

    Outcomes

    Primary Outcome Measures

    Grade of tendon bone healing
    tendon bone healing by knee MRI
    Grade of tendon bone healing
    tendon bone healing by knee MRI
    balanced capacity
    Y balance test
    balanced capacity
    Y balance test
    balanced capacity
    Y balance test
    knee T1 rho value
    knee T1 rho value by functional MRI
    knee T1 rho value
    knee T1 rho value by functional MRI
    knee T2 value
    knee T2 rho value by functional MRI
    knee T2 value
    knee T2 rho value by functional MRI
    knee extension angles
    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
    knee extension angles
    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
    Graft maturity
    tendon bone healing by knee MRI
    Graft maturity
    tendon bone healing by knee MRI
    bone mineral density
    bone mineral density by knee DEX
    bone mineral density
    bone mineral density by knee DEX
    bone mineral density
    bone mineral density by knee DEX
    isokinetic muscle strength
    Knee isokinetic strength test
    isokinetic muscle strength
    Knee isokinetic strength test
    isokinetic muscle strength
    Knee isokinetic strength test

    Secondary Outcome Measures

    Full Information

    First Posted
    May 28, 2023
    Last Updated
    June 27, 2023
    Sponsor
    Peking University Third Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05924178
    Brief Title
    Effects of Preoperative Rehabilitation on Tendon Healing and Bone Mineral Density After ACLR
    Official Title
    A Study on the Effect of Exercise Rehabilitation on Bone Mineral Density and Reconstruction Ligament Tendon Bone Healing After ACL Rupture
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 10, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2026 (Anticipated)
    Study Completion Date
    March 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University Third Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To explore the effect of preoperative exercise rehabilitation on bone mineral density, tendon bone healing, change of cartilage, and gait feature in patients with anterior cruciate ligament rupture.
    Detailed Description
    Anterior Cruciate Ligament (ACL) injury is one of the most common sports injuries. It is a serious knee injury. The fracture of ACL can cause functional instability of knee joint, damage of meniscus and articular cartilage, and even induce knee osteoarthritis and other diseases. It has great influence on knee joint and even lower limb function of patients. Arthroscopic ACL reconstruction has become the first choice in clinical treatment of ACL fracture. ACL fracture can cause local knee joint osteoporosis, and reconstruction surgery can also affect tendon bone healing, bone canal enlargement, rehabilitation period, gait, articular cartilage degradation, etc. This study intends to conduct preoperative rehabilitation intervention for young people with anterior fork rupture, and explore the effects of exercise rehabilitation on knee bone mineral density, muscle strength, proprioceptive ability and other aspects after ACL rupture, as well as the effects of knee bone mineral density, tendon bone healing, bone tunnel aperture, motor function, gait characteristics and cartilage degradation after reconstruction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anterior Cruciate Ligament Rupture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    Before ACL reconstruction,40 minutes of rehabilitation training was performed 3 times a week for 6 weeks, and gotted regular treatment. The ACL reconstruction was followed by a 0.5 year rehabilitation.
    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    Regular rehabilitation training was not performed before ACL reconstruction, got regular treatment. The ACL reconstruction was followed by a 0.5 year rehabilitation.
    Intervention Type
    Behavioral
    Intervention Name(s)
    exercise rehablitation
    Intervention Description
    Preoperative exercise rehabilitation in experimental group was performed.
    Intervention Type
    Behavioral
    Intervention Name(s)
    routine treatment
    Intervention Description
    The control group receives conventional treatment preoperative.
    Primary Outcome Measure Information:
    Title
    Grade of tendon bone healing
    Description
    tendon bone healing by knee MRI
    Time Frame
    At 6 monthes post operation.
    Title
    Grade of tendon bone healing
    Description
    tendon bone healing by knee MRI
    Time Frame
    At 1 year post operation.
    Title
    balanced capacity
    Description
    Y balance test
    Time Frame
    At preoperative.
    Title
    balanced capacity
    Description
    Y balance test
    Time Frame
    At 6 monthes post operation.
    Title
    balanced capacity
    Description
    Y balance test
    Time Frame
    At 1 year post operation.
    Title
    knee T1 rho value
    Description
    knee T1 rho value by functional MRI
    Time Frame
    At 6 months post operation.
    Title
    knee T1 rho value
    Description
    knee T1 rho value by functional MRI
    Time Frame
    At 1 year post operation.
    Title
    knee T2 value
    Description
    knee T2 rho value by functional MRI
    Time Frame
    At 6 months post operation.
    Title
    knee T2 value
    Description
    knee T2 rho value by functional MRI
    Time Frame
    At 1 year post operation.
    Title
    knee extension angles
    Description
    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
    Time Frame
    At 6 months post operation.
    Title
    knee extension angles
    Description
    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
    Time Frame
    At 1 year post operation.
    Title
    Graft maturity
    Description
    tendon bone healing by knee MRI
    Time Frame
    At 6 monthes post operation.
    Title
    Graft maturity
    Description
    tendon bone healing by knee MRI
    Time Frame
    At 1 year post operation.
    Title
    bone mineral density
    Description
    bone mineral density by knee DEX
    Time Frame
    At preoperative.
    Title
    bone mineral density
    Description
    bone mineral density by knee DEX
    Time Frame
    At 6 monthes post operation.
    Title
    bone mineral density
    Description
    bone mineral density by knee DEX
    Time Frame
    At 1 year post operation.
    Title
    isokinetic muscle strength
    Description
    Knee isokinetic strength test
    Time Frame
    At preoperative.
    Title
    isokinetic muscle strength
    Description
    Knee isokinetic strength test
    Time Frame
    At 6 monthes post operation.
    Title
    isokinetic muscle strength
    Description
    Knee isokinetic strength test
    Time Frame
    At 1 year post operation.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18~40 years old, diagnosed ACL rupture by MRI; The first unilateral ACL rupture requires reconstruction at our hospital; Greater than 6 weeks from trauma and within 6 months. Exclusion Criteria: Be older than 40 years, or less than 18 years old Within 8 weeks of the onset of the trauma, or more than 1 year Severe injury to other knee ligaments History of knee trauma
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shuang Ren
    Phone
    17610252992
    Email
    xixishuang123@126.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effects of Preoperative Rehabilitation on Tendon Healing and Bone Mineral Density After ACLR

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