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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Meir Medical Center.
Recruitment status was  Available
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01112332
First received: April 26, 2010
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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

  1. Values in increasing speeds from walking to running.
  2. Changing resistance and incline on an elliptical trainer
  3. Ground jogging.
  4. Stair climbing.
  5. Treadmill running.
  6. Walking.

Condition Intervention
Percentage Body-Weight
Weight-Bearing Values
Weight-bearing Gait Characteristics
Device: SmartStep insole

Study Type: Expanded Access     What is Expanded Access?
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

Further study details as provided by Meir Medical Center:

Study Start Date: March 2010
Intervention Details:
    Device: SmartStep insole
    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.
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

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112332

Contacts
Contact: Yonatan Kaplan, BSc MSc +972 2 502 3941 Sportmed@zahav.net.il

Locations
Israel
Jerusalem Sports Medicine Institute, Lerner Sports Center, Hebrew University of Jerusalem
Jerusalem, Israel
Contact: Yonatan Kaplan, BSc MSc    +972 2 502 3941    Sportmed@zahav.net.il   
Principal Investigator: Ezequiel Palmanovich, MD         
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Ezequiel Palmanovich, MD Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01112332     History of Changes
Other Study ID Numbers: 042-2010
Study First Received: April 26, 2010
Last Updated: August 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 11, 2014