Weight-bearing Deficits Clinical Trial
Official title:
The Use of a Biofeedback Insole Weight-bearing Measuring Device in Determining Weight-bearing Deficits Following Anterior Cruciate Ligament Reconstruction
The objective of this clinical trial is to in determining weight-bearing deficits following anterior cruciate ligament reconstruction.
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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic