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Percentage Body-WeightSSW001NCT01112332

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

A study testing SmartStep insole in people with Percentage Body-Weight and Weight-Bearing Values, run by Meir Medical Center at 1 site in Israel.

Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 1. Values in increasing speeds from walking to running. 2. Changing resistance and incline on an elliptical trainer 3. Ground jogging. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SmartStep insole
Type of treatment
Medical device
How many people
Not given
Where
1 siteIsrael
Study dates
Mar 2010to not given
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Yonatan Kaplan, BSc MSc contact

+972 2 502 3941

Sportmed@zahav.net.il

Israel1 site
  • Jerusalem Sports Medicine Institute, Lerner Sports Center, Hebrew University of Jerusalem

    Jerusalem

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

    Ezequiel Palmanovich, MD

    Available

Other trials in Israel

About this study

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

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.
Read the 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.

Being tested
SmartStep insole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SmartStep insoleDevice

    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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2010 (estimated)
  2. Study startMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT01112332
Sponsor's protocol ID
042-2010
Acronym
SSW001
Status last verified
Aug 2012
First submitted
26 Apr 2010
Last updated
10 Aug 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing SmartStep insole in people with Percentage Body-Weight and Weight-Bearing Values, run by Meir Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yonatan Kaplan, BSc MSc (+972 2 502 3941, Sportmed@zahav.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2012.

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