Clinical Trial Details
— Status: Available
Administrative data
| NCT number |
NCT01112332 |
| Other study ID # |
042-2010 |
| Secondary ID |
|
| Status |
Available |
| Phase |
N/A
|
| First received |
April 26, 2010 |
| Last updated |
August 9, 2012 |
| Start date |
March 2010 |
Study information
| Verified date |
August 2012 |
| Source |
Meir Medical Center |
| Contact |
Yonatan Kaplan, BSc MSc |
| Phone |
+972 2 502 3941 |
| Email |
Sportmed[@]zahav.net.il |
| Is FDA regulated |
No |
| Health authority |
United States: Food and Drug Administration |
| Study type |
Expanded Access
|
Clinical 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.
4. Stair climbing.
5. Treadmill running.
6. Walking.
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.
