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Weight-bearing Measuring Device Following Anterior Cruciate Ligament Reconstruction

Primary Purpose

Weight-bearing Deficits

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Smart_Step weight bearing insole
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Weight-bearing Deficits focused on measuring weight bearing, acl

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 27, 2010
Last Updated
August 29, 2011
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01127685
Brief Title
Weight-bearing Measuring Device Following Anterior Cruciate Ligament Reconstruction
Official Title
The Use of a Biofeedback Insole Weight-bearing Measuring Device in Determining Weight-bearing Deficits Following Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight-bearing Deficits
Keywords
weight bearing, acl

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Smart_Step weight bearing insole
Other Intervention Name(s)
weight bearing biofeedback insole device
Intervention Description
The use of a weight-bearing measuring device in determining weight-bearing deficits following Anterior Cruciate Ligament Reconstruction
Primary Outcome Measure Information:
Title
The Use of a Biofeedback Insole Weight-bearing Measuring Device in Determining Weight-bearing Deficits Following Anterior Cruciate Ligament Reconstruction
Description
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
Time Frame
During their regular training the participants will use the flexible, light weight, force-sensing insole for few minutes to receive the parameters

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Jerusalem Sports Medicine Institute, Lerner Sports Center, Hebrew University of Jerusalem.
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

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Weight-bearing Measuring Device Following Anterior Cruciate Ligament Reconstruction

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