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Weight-bearing Measuring Device to Determine Normative Percentage Body-Weight/Weight-Bearing Values and Weight-bearing Gait Characteristics (SSW001)

Primary Purpose

Percentage Body-Weight, Weight-Bearing Values, Weight-bearing Gait Characteristics

Status
Available
Phase
Locations
Israel
Study Type
Expanded Access
Intervention
SmartStep insole
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Percentage Body-Weight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Male or female patients more than 18 years old, that usually training in Lerner Central Sport, Hebrew University - Jerusalem
  • Pain free in their hip, knee and ankle/foot joints for at least a 3 month period prior to testing
  • Patients who are willing to participate in the trial, to come to all scheduled visits 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.
  • Previous surgery in the hip, knee, ankle/foot less than 2 years previously.
  • Non cooperative patient with the basic rehab program.

Sites / Locations

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 26, 2010
Last Updated
August 9, 2012
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01112332
Brief Title
Weight-bearing Measuring Device to Determine Normative Percentage Body-Weight/Weight-Bearing Values and Weight-bearing Gait Characteristics
Acronym
SSW001
Official Title
: Use of an Innovative Weight-bearing Measuring Device to Determine Normative Percentage Body-Weight/Weight-Bearing Values and Weight-bearing Gait Characteristics in Different Physiologic Conditions
Study Type
Expanded Access

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Available
Study Start Date
March 2010 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this clinical trial is to determine normative Percentage Body-Weight/Weight-Bearing Values and Weight-bearing Gait Characteristics in different physiologic conditions Values in increasing speeds from walking to running. Changing resistance and incline on an elliptical trainer Ground jogging. Stair climbing. Treadmill running. Walking.
Detailed Description
Background information 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. Accurate percentage body weight/weight-bearing (PBW/WB) value analysis in walking has up been investigated in laboratory settings, using balance plate systems and force plate platforms. The aim of this study is to evaluate normal gait characteristics and PBW/WB values using a relatively new hand-held, portable, weight-bearing measuring device (Smartstep™). During their regular training the participants will use the flexible, light weight, force-sensing insole for few minutes to receive the parameters subjects. In order to accurately control the speed changes, the test measurements will be conducted on a treadmill (Technogym™ "run excite 700"). The tested speeds will be 4,6,8,10,12,14,16,18 and 20 km/hr consecutively. Each subject will run for a 15 second time period for each speed. 25 subjects. The test measurements will be conducted on an Elliptical trainer (Precor USA 576i EFX). The protocol includes 3 tests. In the first test, resistance and incline will be paired together in increasing order at the set device levels of 1, 5, 10, 15, and 20. In the second test, the resistance will be held constant at level 1, while the incline will be increased from levels 1 to 20 in increments of five. In the third test, the incline will remain constant at level 1, while the resistance will be increased from levels 1 to 20 in increments of five. Each subject will be tested over a 20 second time period for each of the changed resistances and inclines. The subjects will be instructed to keep a steady pace within the range of steps/min = 70-95. 40 subjects. The test subjects will be instructed to jog at their normal speed on a solid ground surface over a distance of 16 meters. 40 subjects. The test measurements will be conducted on a flight of 10 stairs, each 17cm high. The subjects will be instructed to ascend and descend the stairs at their normal pace. 40 subjects. The tested speed will be held at 8.5 km/hr on a treadmill (Technogym™ "run excite 700"). Each subject will run for a 15 second time period. 40 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
Percentage Body-Weight, Weight-Bearing Values, Weight-bearing Gait Characteristics

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
SmartStep insole
Intervention Description
Smart StepTM is an innovative biofeedback and monitoring system designed to help clinicians effectively guide patients with compromised lower limb function due to orthopedic or neurological trauma towards optimal gait performance. It records and analyzes key gait parameters and provides instantaneous and accurate audio and visual feedback.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Male or female patients more than 18 years old, that usually training in Lerner Central Sport, Hebrew University - Jerusalem Pain free in their hip, knee and ankle/foot joints for at least a 3 month period prior to testing Patients who are willing to participate in the trial, to come to all scheduled visits 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. Previous surgery in the hip, knee, ankle/foot less than 2 years previously. Non cooperative patient with the basic rehab program.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yonatan Kaplan, BSc MSc
Phone
+972 2 502 3941
Email
Sportmed@zahav.net.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ezequiel Palmanovich, MD
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jerusalem Sports Medicine Institute, Lerner Sports Center, Hebrew University of Jerusalem
City
Jerusalem
Country
Israel
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonatan Kaplan, BSc MSc
Phone
+972 2 502 3941
Email
Sportmed@zahav.net.il
First Name & Middle Initial & Last Name & Degree
Ezequiel Palmanovich, MD

12. IPD Sharing Statement

Learn more about this trial

Weight-bearing Measuring Device to Determine Normative Percentage Body-Weight/Weight-Bearing Values and Weight-bearing Gait Characteristics

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