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临床试验/NCT01127685
NCT01127685已完成1 期

The Use of a Biofeedback Insole Weight-bearing Measuring Device in Determining Weight-bearing Deficits Following Anterior Cruciate Ligament Reconstruction

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年5月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
30
试验地点
1
主要终点
The Use of a Biofeedback Insole Weight-bearing Measuring Device in Determining Weight-bearing Deficits Following Anterior Cruciate Ligament Reconstruction

研究概览

简要总结

The objective of this clinical trial is to in determining weight-bearing deficits following anterior cruciate ligament reconstruction.

详细描述

Orthopedic surgeons and rehabilitation physicians frequently request limited weight-bearing for prolonged periods following certain bony or soft tissue pathologies as well as certain lower - limb surgical procedures. Walking, stair climbing, jogging, elliptical training and running on treadmill are a common activity that the injured athlete will seek to return to as soon as possible following injury or surgery. In order for the physician to be able to advise regarding weight-bearing, the Percentage Body-Weight/Weight-Bearing (PBW/WB) values in increasing walking, jogging speeds, elliptical training must be known. These parameters as well as the gait distribution changes have eluded the rehabilitation community, mainly due to the technical inability to measure these paradigms.

There are no short-term studies quantifying weight-bearing deficits as well as weight-bearing gait distribution characteristics following Anterior Cruciate Ligament Reconstruction (ACLR). Furthermore, there are no published studies that have investigated whether differences exist between various surgical procedures and replacement graft choices in the acute- phase (0-3 weeks) post surgery

Descriptive clinical trial. During their regular training the participants will use the flexible, light weight, force-sensing insole for few minutes to receive the parameters 30 subjects. The test subjects will be instructed to walk at their normal speed on a solid ground surface over a distance of 16 meters.

The results will be analyzed and a table of normal values will be established including average PBW/WB values for the entire, hind and fore-foot as well as gait distribution changes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Male or female patients more than 18 years old, derivate to physiotherapy treatment in Lerner Central Sport, Hebrew University - Jerusalem
  • Patients who are willing to participate in the trial and to sign the informed consent forms.

排除标准

  • Patients receiving other methods of treatment to this area,
  • Patients with concomitant other injury of the hip, knee, ankle or foot.
  • Non cooperative patient.

结局指标

主要结局

The Use of a Biofeedback Insole Weight-bearing Measuring Device in Determining Weight-bearing Deficits Following Anterior Cruciate Ligament Reconstruction

时间窗: During their regular training the participants will use the flexible, light weight, force-sensing insole for few minutes to receive the parameters

Descriptive clinical trial. During their regular training the participants will use the flexible, light weight, force-sensing insole for few minutes to receive the parameters 30 subjects. The test subjects will be instructed to walk at their normal speed on a solid ground surface over a distance of 16 meters. The results will be analyzed and a table of normal values will be established including average PBW/WB values for the entire, hind and fore-foot as well as gait distribution changes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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