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Completed

NCT Number: NCT01127685

Weight-bearing Measuring Device Following Anterior Cruciate Ligament Reconstruction

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jerusalem Sports Medicine Institute, Lerner Sports Center, Hebrew University of Jerusalem.

Jerusalem, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Smart_Step weight bearing insole

Device

The use of a weight-bearing measuring device in determining weight-bearing deficits following Anterior Cruciate Ligament Reconstruction

Other names: weight bearing biofeedback insole device

Primary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
May 21, 2010
Registry last updated
Aug 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.