Weight-bearing Measuring Device to Determine Normative Percentage Body-Weight/Weight-Bearing Values and Weight-bearing Gait Characteristics
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.
Study Design
N/A
Conditions
Percentage Body-Weight
Intervention
SmartStep insole
Location
Jerusalem Sports Medicine Institute, Lerner Sports Center, Hebrew University of Jerusalem
Jerusalem
Israel
Status
Available
Source
Meir Medical Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01112332
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Body Composition
The relative amounts of various components in the body, such as percentage of body fat.
Ideal Body Weight
Expected weight of a healthy normal individual based on age, sex, and height. Thus, a malnourished person would weigh less than their ideal body weight.
Body Mass Index
An indicator of body density as determined by the relationship of BODY WEIGHT to BODY HEIGHT. BMI=weight (kg)/height squared (m2). BMI correlates with body fat (ADIPOSE TISSUE). Their relationship varies with age and gender. For adults, BMI falls into these categories: below 18.5 (underweight); 18.5-24.9 (normal); 25.0-29.9 (overweight); 30.0 and above (obese). (National Center for Health Statistics, Centers for Disease Control and Prevention)
Skinfold Thickness
The measurement of subcutaneous fat located directly beneath the skin by grasping a fold of skin and subcutaneous fat between the thumb and forefinger and pulling it away from the underlying muscle tissue. The thickness of the double layer of skin and subcutaneous tissue is then read with a caliper. The five most frequently measured sites are the upper arm, below the scapula, above the hip bone, the abdomen, and the thigh. Its application is the determination of relative fatness, of changes in physical conditioning programs, and of the percentage of body fat in desirable body weight. (From McArdle, et al., Exercise Physiology, 2d ed, p496-8)
Overweight
A status with BODY WEIGHT that is above certain standard of acceptable or desirable weight. In the scale of BODY MASS INDEX, overweight is defined as having a BMI of 25.0-29.9 kg/m2. Overweight may or may not be due to increases in body fat (ADIPOSE TISSUE), hence overweight does not equal "over fat".
Clinical Trials
Study of How An Ankle Strap Changes Effects of Insole Treatment for Knee Osteoarthritis
The goal of this project is to assess the effects of an ankle strap on the effectiveness of a laterally-wedged insole with ankle strapping in reducing knee symptoms and improving static an...
Medial-Wedge Insole is Highly Effective in the Treatment of Valgus Knee Osteoarthritis
- To assess the efficacy of medial-wedge insole in valgus knee osteoarthritis (OA). - We hypothesized that medial-wedged insoles are biomechanically effective and should reduce l...
Clinical Use of Andante SmartStep System in Gait Rehabilitation
The purpose of this study is to evaluate the effectiveness of the biofeedback gait training device in improving load bearing over an operated limb, during post-operative gait training ther...
A Comparison of Insoles Used to Prevent Neuropathic Diabetic Foot Ulceration
Importance of the topic: Lower extremity amputation is a costly complication of diabetes for both the NHS and the patient. Amputation may be avoided if the preceding foot ulceration can b...
To assess the efficacy of TrueContour Insoles versus the current standard of care insoles in recurrence of plantar ulcers in men and women, 18 years of age or older at the time of consent...
PubMed Articles
BACKGROUND: Most of the weight loss with the BioEnterics intragastric balloon (BIB) has occurred during the first 3-4 months. This study aimed to evaluate the effect of initial weight loss on long-te...
Objective-To determine whether mass-to-splenic volume ratio or splenic weight as a percentage of body weight was significantly different between dogs with benign versus malignant splenic masses. Des...
Investigation of foot plantar pressure: experimental and numerical analysis.
The analysis of interaction phenomena occurring between the plantar region of the foot and insole was investigated using a combined experimental-numerical approach. Experimental data on the plantar pr...
BACKGROUND/OBJECTIVES:Identifying critical periods of greater weight gain could provide useful information to combat the obesity epidemic. We tested whether body weight (BW), body fat percentage (BF%)...
ABSTRACT: BACKGROUND: Body weight is at least partly controlled by the choices made by a human in response to external stimuli. Changes in body weight are mainly caused by energy intake. By analyzing...
