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临床试验/NCT05924178
NCT05924178招募中不适用

A Study on the Effect of Exercise Rehabilitation on Bone Mineral Density, Reconstruction Ligament Tendon Bone Healing and Cartilage After ACL Rupture and Patellar Dislocation

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年7月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Graft maturity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18~40 years old, diagnosed ACL rupture or Patellar Dislocation by MRI;
  • The first unilateral ligamenta reconstruction at our hospital;

排除标准

  • Be older than 40 years, or less than 18 years old
  • Severe injury to other knee ligaments
  • History of knee trauma

研究组 & 干预措施

control group

Active Comparator

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

干预措施: routine treatment (Behavioral)

experimental group

Experimental

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.

干预措施: exercise rehablitation (Behavioral)

结局指标

主要结局

Graft maturity

时间窗: At 1 year post operation.

tendon bone healing by knee MRI

bone mineral density

时间窗: At 1 year post operation.

bone mineral density by knee DEX

isokinetic muscle strength

时间窗: At 1 year post operation.

Knee isokinetic strength test

knee T1 rho value

时间窗: At 1 year post operation.

knee T1 rho value by functional MRI

knee T2 value

时间窗: At 1 year post operation.

knee T2 rho value by functional MRI

balanced capacity

时间窗: At 1 year post operation.

Y balance test

Grade of tendon bone healing

时间窗: At 1 year post operation.

tendon bone healing by knee MRI

knee extension angles

时间窗: At 1 year post operation.

Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping

Grade of tendon bone healing

时间窗: At 6 monthes post operation.

tendon bone healing by knee MRI

balanced capacity

时间窗: At preoperative.

Y balance test

balanced capacity

时间窗: At 6 monthes post operation.

Y balance test

knee T1 rho value

时间窗: At 6 months post operation.

knee T1 rho value by functional MRI

knee T2 value

时间窗: At 6 months post operation.

knee T2 rho value by functional MRI

knee extension angles

时间窗: At 6 months post operation.

Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping

Graft maturity

时间窗: At 6 monthes post operation.

tendon bone healing by knee MRI

bone mineral density

时间窗: At preoperative.

bone mineral density by knee DEX

bone mineral density

时间窗: At 6 monthes post operation.

bone mineral density by knee DEX

isokinetic muscle strength

时间窗: At preoperative.

Knee isokinetic strength test

isokinetic muscle strength

时间窗: At 6 monthes post operation.

Knee isokinetic strength test

Grade of tendon bone healing

时间窗: At 2 years post operation.

tendon bone healing by knee MRI

balanced capacity

时间窗: At 2 years post operation.

Y balance test

Graft maturity

时间窗: At 2 years post operation.

tendon bone healing by knee MRI

isokinetic muscle strength

时间窗: At 2 years post operation.

Knee isokinetic strength test

次要结局

  • The HU value of CT(at pre-operation)
  • Thigh Circumference(At 2 years post operation.)
  • Thigh Circumference(At 1 year post operation.)
  • Thigh Circumference(At 6 monthes post operation.)
  • Thigh Circumference(At pre-operation.)
  • Single-Leg Hop(At 1 year post operation.)
  • Single-Leg Hop(At 2 years post operation.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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