IsoPED Comparative Analysis

Transcription

Version: 0.7
Released: June 29, 2011
Date of approval:
Document Summary
Document Item
Current Value
Status
Draft
Document Description Comparison of Comparative Analysis
IsoPED and other products
Contributors
Name (Product Version)
Organization
Footmaxx
Footmaxx
IsoPED version II
Neuromuscular Engineering & Technology LLC
SPENCO
SPENCO Medical
Pedag
Pedag International
California Orthotics Inc., Yorthotics
California Orthotics Inc
Log of Changes
Issue No.
Date of Change
Changed By
Summary of Change
0.1
29-Jun-11
Rob Gilliland
Initial draft
0.2
08-August-11
Alistair McGregor
Updates including additional
products
0.3
10-August-11
Terence Vardy
Editing
0.4
22-August-11
Alistair McGregor
Updated Testimonials
0.5
25-August-11
Alistair McGregor
Updated product weights
0.6
26-August-11
Alistair McGregor
Included placeholders for Ft.
Myer and West Point feedback
0.7
03-September-11
Alistair McGregor
Included RSscan information
Page 2 of 26
Page 3 of 26
TABLE OF CONTENTS
1. Preamble .............................................................................................................................. 5 1.1. Document purpose........................................................................................................ 5 2. IsoPED Comparative Analysis, description ........................................................................ 6 2.1. Background .................................................................................................................. 6 2.2. Products ........................................................................................................................ 6 3. Subjective User Reviews ..................................................................................................... 7 4. Subject Comments ...................................................................................................... 10 4.1. Comments by men:..................................................................................................... 10 4.2. Comments by women ................................................................................................. 11 5. Footmaxx ........................................................................................................................... 12 6. SPENCO............................................................................................................................ 14 7. Pedag ................................................................................................................................. 16 8. California Orthotics Inc., Yorthotics ................................................................................. 18 9. Comparison Table ............................................................................................................. 20 10. Does the IsoPED Insole reduce lower extremity injuries? .............................................. 21 11. Can the RSscan footscan D3D orthotic reduce lower limb injury in an initial Military
training setting? ........................................................................................................................ 22 1. Introduction ................................................................................................................... 22 2. Aim ................................................................................................................................ 22 3. Methods ......................................................................................................................... 22 4. Ethics ............................................................................................................................. 24 5. Inclusion/Exclusion ....................................................................................................... 24 6. Results ........................................................................................................................... 24 7. Statistical analysis ......................................................................................................... 24 8. Discussion ..................................................................................................................... 25 9. Limitations .................................................................................................................... 25 10. Conclusions ................................................................................................................. 25 11. References ................................................................................................................... 25 IsoPED Comparative Analysis
Page 4 of 26
1. Preamble
The IsoPED product (Insole) is to be compared to the following products in a
comparative study contained in this document:
• Footmaxx Insole
• SPENCO Insole
• Pedag Insole
• California Orthotics Inc.
1.1. Document purpose
The purpose of this document is to compare IsoPED and the four other products.
The questions posed in this project are:-
Does the IsoPED Insole reduce lower extremity injuries?
How does IsoPED compare with other Insoles.
The report is focused in the following areas:
• Illustrations
• Technical Specs
• Costs
• Delivery Times
• Subjective user Reports
Page 5 of 26
2. IsoPED Comparative Analysis, description
2.1. Background
Direct Comparison between the products which are designed to fulfill the same
role as an insole.
2.2. Products
IsoPED IsoPED is an easy to use insole system that provides low cost high quality
insoles.
Foot complaints are the major source of discomfort and duty time lost by
soldiers. This is not surprising given that they spend so much active duty time on
their feet.
The design process fits well with our data base developed for service personnel,
active and retired, and complements our other health products/equipment.
Combined with our IsoBALANCE equipment the IsoPED profile provides further
information to assist with quality soldier care.
IsoPED is a quality product with an accurate diagnostic base. Further, the
design/fitting is easy to undertake - less than 10 minutes - operator friendly, and
is highly portable.
The sensor base is robust with small dimensions and is extremely portable.
IsoPED Insoles carry a 12 month Warranty.
The pressure contours of your feet are measured statically and dynamically
under the actual ‘person’ load.
Product Details
• Price: $170 per pair
Page 6 of 26
3. Subjective User Reviews
West Point Military Academy
Purpose
The purpose of this study was to assess the impact of the ISOPED insert
on foot comfort associated with daily physical training conducted in standard
issue Army boots.
Methods
A total of 366 cadets from the United States Military Academy were fitted
with ISOPED foot inserts to be worn in their boots. All cadets were members of
companies involved in the Sandhurst competition. Sandhurst is an annual
military tactics competition held at West Point and involves teams from military
academies from around the world. The competition takes place in April.
Sandhurst companies were asked to participate in this study because their 3hour daily training regimen calls for wearing of boots.
Subjects were fitted for inserts using the RS Scan International plate and
Footscan system. Foot plantar pressure pattern was determined by walking
across the force plate system with a natural gait. Walking foot pressure
measurements were made on concrete-based laboratory floor. To ensure a
natural gait, subjects were placed approximately 5m from the foot plate and
asked to walk across the footplate; this was accomplished with a minimum of 4steps. Trials were repeated if the foot pressure record was outside the perimeter
of the footplate or if there was a visually recognizable alteration in gait pattern in
an attempt to strike the footplate. Three successful foot plant pressure records
were collected for each foot and used to build the insert.
Subjects were given one pair of the ISOPED custom fit inserts and asked
to wear them whenever they were wearing and/or training in their standard issue
boots. With regard to use, the subjects were simply instructed to gradually
increase use of the inserts during the first week of use. No other specific details
of use were provided. Following one month of use (not including the 1-week
initiation period) subjects were asked to complete a foot comfort questionnaire.
The questionnaire was completed anonymously online without investigator
presence.
Results
Of the the 366 subjects fitted for inserts; 45 subjects were excluded from
the study because the inserts were delivered to the investigators with less than
one month prior to the Sandhurst competition precluding the required study
duration. Comfort questionnaires were received from 271 subjects (men:
n=246; women: n=25) for a 85% return rate.
The time required to complete three pressure records for each foot was
relatively short; approximately 5-6 minutes per subject. No subject required
more than six trials to acquire the three foot pressure records for one foot.
Questionnaire Results
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Regarding the finished quality of the ISOPED product 38% of subjects
rated them as Excellent (men=40%; women=8%), 44% as Good (men=41%;
women=44%), 14% as Fair (men=4%; women=20%) and 4% as Poor
(men=6%; women=4%). There were 11 subject complaints that the inserts did
not fit; in all cases the lack of fit was traced to incorrect boot size provided at
fitting.
75% of respondents reported no previous use of orthotics or inserts
(men=76%; women 56%). Of those reporting orthotic/insert use 28% reported
less than 1-year (men=29%; women=27%) while 67% reported use between 1
and 5 years (men=69%; women=73%). Two men and no women reported
using orthotics/insert for greater than 5 years. The origin of orthotic/insert was
mostly personal desire (only 8 subjects reported prescription orthotic use). The
non-prescription insert brands varied widely; including Dr. Scholls, Qfactor, Sole,
GEl inserts, Sweetfeet Insoles, Walmart, Aline, Heel Orthotics, Power Step,
Superfeet, and unknown. No more than 4 subjects reported reported use of the
same brand.
Assessment of activity patterns was determined by exercise frequency and
intensity. Exercise frequency was reported in a range of days/week. Exercise
intensity was demarcated as High (repeated bouts of sprinting, climbing, etc of
short duration), Low (long duration running or marching) or Mix (a combination
of High and Low. There was no assessment concerning ruck loads carried during
either High or Low activity; although if carried the load never exceeded 30
pounds. Activity pattern with the ISOPED inserts in the the boots was reported
as follows:
Frequency
Men
1-3x/Week n=90
4-5x/week n=77
6-7x/week n=18
Women
n=19
n=2
n=1
Intensity
Men Women
Low n=42
n=13
High n=52
n=5
Mix
n=90
n=7
Subjects were asked to provide an estimate of how long it took to "break
in" the inserts. Responses are summarized below:
>1-week
1-week
1-2-weeks
2-weeks
2-3weeks
3-4-weeks
>1month
Unsure
Men
n=45
n=39
n=10
n=16
n=8
n=5
n=2
n=1
Women
n=5
n=5
n=1
n=1
n=1
Regarding their assessment of foot comfort with the ISOPED inserts
relative to their previous situation 5% (men=5%; women=0%) rated their foot
comfort as Much Improved while 41% rated foot comfort as Improved by the
ISOPED insert (men=40%; women=52%). 36% of respondents reported no
change (Same) in foot comfort with ISOPED inserts (men=35%; women=40%).
Increased Pain was reported by 18% of respondents (men=20%; women=4%).
Of those rating Increased Pain, complaints ranged from wrong size (addressed
Page 8 of 26
above) or roughly as the following: didn't feel natural (n=7), didn't absorb shock
(n=3), arches too high (n=6).
Of individuals that were using orthotics/inserts prior to the ISOPED insert
2% (men=2%; women=0%) reported that their foot comfort was Much
Improved while 55% (men=55%; women=55%) report Improved foot comfort
compared to their previous orthotic/insert. No change (Same) in foot comfort
compared to their previous orthotic/insert was reported by 31% of respondents
(men=30%; women=36%). 12% of respondents (men=12%; women=9%)
reported reduced foot comfort compared to their previous orthotic/insert.
Subjects were asked to report pain that they were experiencing in other
areas of the body. A summary of reported areas of pain are as follows:
Lower back
Hip
Knee
Neck
Upper back
Men
n=19
n=5
n=29
n=1
n=1
Women
n=4
n=1
n=5
n=1
Given this reported pain distribution one male subject reported that the
pain was Much Improved while wearing the ISOPED insert as compared to their
previous orthotic/insert. 38% of these subjects (men=35%; women=55%)
reported that area pain was Improved while 58% reported (men=60%;
women=45%) that pain was unchanged (Same) while wearing the ISOPED
insert. Pain was reported to be increased with the ISOPED insert by two men
and no women.
Finally, subjects were asked an open-ended question regarding general
comments about the ISOPED insert. A summary of those comments is given at
the end of this section.
Conclusions:
The ISOPED insert had a very favorable impact on foot comfort while
wearing Army general-issue boots and engaging in high-intensity and/or longduration exercise with 46% of subjects reporting improved foot comfort during
exercise.
ISOPED appears to be equal or better to other forms of orthotics/inserts
based on improved (46%) or same (36%) comfort ratings compared to previous
orthotic/insert use.
Perhaps most interesting was the improvement in non-foot related pain by
the ISOPED insert reported in 40% of subjects.
Future Directions
Based on the present results is appears that the ISOPED insert has a
positive impact on the foot while exercising in boots. Thus, additional research
into the physiological or psychological basis for this increased efficacy appears
warranted. Thus, we recommend the following research direction:
1. Follow-up questionnaires: Subjects from the study reported herein will
be asked to complete a follow-up questionnaire this fall that will probe the rate of
continued use, comfort, satisfaction, durability, etc of the ISOPED insert given
them last spring.
Page 9 of 26
2. Foot-ankle function during walking and running gait.
3. Changes in foot architecture and muscle activation patterns associated
with exercise of various modality, intensity, and duration.
4. The impact of ISOPED insets on foot architecture and muscle activation
patterns associated with exercise of various modality, intensity, and duration.
5. Prospective epidemiological study of insert use on back and leg injury
rate and severity.
4.
Subject Comments
The following is a summary of comments provide by the subjects in response to an openended question on the study questionnaire.
4.1. Comments by men:
…produces a stable and comfortable platform that prevented pain and cramps.
…extremely supportive of my arch.
I felt more foot support because of the inserts and less discomfort when walking.
Left insole fit and worked great, the right did not fit
…got a few blisters breaking them in; …nice feeling having my boot form to me foot perfectly
…I feel like it distributes my weight more evenly
…insole fit perfectly to my feet and gave good support
…liked that it gave me more support
…helped back; good fit; not gel
…better posture.
The insole increased the comfort of my boots
Very comfortable; elevate foot, make running easier
Service and durability
Improved agility; increased comfort
…felt really good, especially for arch support
One piece construction; fitting was easy
Made boots fit better; made walking more comfortable
Good support; no smell; not too rigid in its construction
Better foot posture; forces me to run on my toes
Made boots feel like running shoes
Support, personalized, ease
Once broken in they did feel better
The heel and ball area felt very comfortable
They saved my feet on the Air Assault ruck march; they were not as sore as usually after a
march/run
Once they were broken I could they supported my whole body; insoles worked great and
improved my performance when conduction training for Sandhurst.
Great arch support; I am still wearing them; they helped decrease the pain of my shin splints
and the pain is nearly gone; great inserts
Good design and support
Much more solid foundation; more comfort
They worked; when I wore them I had no lower extremity injuries, but once I discontinued use
of the product I immediately developed knee injuries
Fantastic arch support for walking
Makes the boots more comfortable during high stress activities
Page 10 of 26
…better than Dr. Scholl’s and Aline
…walk faster, feet feel better
It did decrease pain and increase comfort towards the end of the trial
4.2. Comments by women
More comfort; I fell that I can stand for a longer period of time
Boots were more comfortable
Very comfortable; I couldn’t tell that I was wearing them
I like the inserts but didn’t like only wearing them in my boots.
Once I got used to them they felt really nice on my arches
Improved comfort when standing, especially for long periods
Page 11 of 26
5. Footmaxx
Footmaxx custom foot orthotics can be made from the digitized data translated
through the Metascan system or from static casts. Custom labs manufacture
orthotics from static casts by pouring a positive plaster cast and then vacuumforming material to form the corrective orthotic module.
The MaxxLife™ premium orthotic claims comfort and biomechanical control
guaranteed for one year. Complete with a genuine leather top cover and a fulllength suede bottom, MaxxLife provides versatility and style for those ‘on the go’.
The Footmaxx process (includes delivery times)
Step One: The patient walks across the Footmaxx force plate which contains
960 capacitance points and is scanned by a computer 30 times per second
allowing for 3/100 second interval analysis of each footstep.
Step Two: The Chiropractors review preliminary test results with the patient
explaining the gait line and the 2D and 3D images. For more severe conditions,
the clinician provides additional patient information concerning diagnosis or
specifies additional posting instructions by using various exam screens in the
Footmaxx software.
Step Three: The Chiropractor then sends the patient file to Footmaxx via
modem requesting a Gait & Pressure Analysis Report and/or prescription
orthotics.
Step Four: At the lab, the patient's file is analyzed by MetascanTM, from which a
Gait and Pressure Analysis Report is generated and, if necessary, a prescription
for orthotics is specified.
Step Five: The manufacturing process begins with a specification sheet
generated by Metascan which is coupled with any additional instructions
indicated by the medical practitioner. A semi-rigid orthotic module is instrinically
posted which means that the angle and height of the arch of the orthotic module
is formed and molded based on the prescription needed to correct the patient's
abnormal biomehanics. Instrinic posting is claimed to make Footmaxx orthotics
thin and easy to wear in any type of shoe.
Step Six: When extrinsic posting is specified by a clinician (or Metascan),
Footmaxx offers the same types of materials and modifications available from
any podiatry lab. Extrinisic posting includes any additional materials that must be
added to the orthotic module to help correct abnormal biomechanics. The
orthotic is finished with a topcover, a covering piece of material that absorbs
prespiration or odour. Then it is smoothed and sanded so that it fits comfortably
and easily in the patient's shoes.
Step Seven: Within just days of receiving an orthotic order via modem, the
customization process is complete and the orthotics are sent to the Quality
Control Department where they are carefully checked against the Metascan
prescription and the clinician's instructions.
Step Eight: Once the orthotics are approved by quality control, they are shipped
to the clinician via 2-day courier. Digital patient data is permanently stored at
Footmaxx making patient progress easier to track.
Page 12 of 26
Product Details
• Dynamic Gait Analysis - $99.00 Once Only
• 1st Pair Custom Orthotics - $325.00
• Additional Pairs - $275.00
Subjective User Reviews
http://www.xomreviews.com/footmaxx.com
The views expressed herein are those of the respective authors only.
Author Magic_Mike , on Saturday, April 23, 2011
Very Bad Experience with Footmaxx
My Experience with Footmaxx orthotics was terrible. I bought mine, paid over $500. This
was my second set of orthotics. My first set was done via plaster mould. I used them for
two years, and they were great. This second set was done via the computerized pad.
This second set was recommended by my chiropractor.
I got the orthotics and used them for three months. Over that time, my feet and knees
felt worse and worse. When I mentioned it to a friend, the friend suggested it might be
the orthotics that was causing the problem.
I'm still in pain from the damage these terrible orthotics have caused.
Author ‘paininthefoot’, on Monday, February 07, 2011
My personal experience with this product was not a good one...
I paid over $400 for these inserts and used them for approximately 3 months until the
pain progressed to the point that I could barely walk. I mentioned to my Podiatrist that it
hurt my heal to wear them and he explained that it sometimes takes time to get used to
them and that initially, I should wear them only for short intervals during the day. He
also gave me 3 different injections to no avail. In spite of soaking my feet in ice water,
massage, anti-inflammatory medication, etc., I stopped using them and sought a second
opinion. The second doctor put me in a boot cast and it is helping, although I developed
bursitis on my heel and it is a slow process. I called Footmax to tell them about the
problems that I experienced with their product and asked if they could at least offer me a
partial refund. However, they refused saying that they only have a 45 day satisfaction
guarantee and that it is up to the doctor whether or not to tell his patients about it.
huh?) They went further to say that the doctor never should have prescribed them
without first adding some sort of gel insert in the heel. I can only speak for my personal
experience with these orthotics, which was not a good one, and I could not recommend
them to anyone else with Plantar Fasciitis, especially at this price.
Page 13 of 26
6. SPENCO
Product Description
SPENCO Insoles are the well-known stretch nylon-covered neoprene insoles.
Their "nitrogen" cell, ball-bearing action that is claimed to be particularly suited
to sports that involve a lot of abrupt starting and stopping, like basketball. An
alternative to PPT. SPENCO Footcare products claim that they are made
exclusively with RUBATEX closed-cell neoprene. This unique cushioning system
provides a soft "comfort bubble" to help absorb shock, reduce friction and
improve overall foot comfort. Awarded the Seal of Acceptance by the American
Podiatric Medical Association. Unconditionally, guaranteed for one year. Sizing:
Size 1: Women's 5 - 6 Size 2: Women's 7 - 8, Men's 6 - 7 Size 3: Women's 9 10, Men's 8 - 9 Size 4: Men's 10 - 11 Size 5: Men's 12 - 13 Size 6: Men's 14 - 15
Product Details
•
•
•
•
•
Spenco® PolySorb® Cross Trainer Insoles
Item Weight:5.3 Ounces
ASIN: B000GCKC6E
Item model number: 38-034-03
Pair pack (Insoles) – Accessories price: $19.99
Might have worked out, May 16, 2011
By jazmarz
Amazon Verified Purchase
This review is from: Spenco Polysorb Cross Trainer, Women's 7-8 / Men's 6-7
(Health and Beauty)
After researching multiple websites about insoles I chose this brand. I was looking for a
comfortable insole for my hiking boots and did want to spend the money on Superfeet.
What I didn't notice in the Amazon description was that it was for low arches.
Unfortunately, I had to return them. I am still trying to decide if the total support insole
by Spenco is the way to go. I don't want to have to return something twice.
Good arch and heel support. Experienced some discomfort when worn for a long
time, July 19, 2010
By A. L. Harrison (Philly, pa)
Page 14 of 26
This review is from: Spenco Polysorb Cross Trainer, Men's 12-13 (Health and
Beauty)
I walk, run and play basketball almost daily and figured a product like this could enhance
my experience. I purchased two pairs to try. I used one pair on my basketball sneakers
and the support made a tangible difference in the stress levels that my feet felt as I
played. I also tried a pair in my cross-trainer sneakers. It was uncomfortable wearing
them with my cross-trainers. The arch support dug too far into my arch. Probably
because the sneakers have built-in arch support and the added support from this was too
much. Just for kicks, I also placed them in a pair of casual low-top sneakers and walked
in them for a few hours. They felt great in my casual sneakers. I think it's a very good
product. Provides good support especially in the heel. Good support on the arch, just be
careful about what type of arch support your current shoes offer. If your current shoes
already have decent/good arch support, these may be overkill.
The Best, July 15, 2008
By BCM (Northern California)
This review is from: Spenco Polysorb Cross Trainer, Men's 14-15 (Health and
Beauty)
Awesome insoles, the best I've ever worn. Others hurt my feet so bad it felt like they
were on fire, but I can hike for miles and miles in these. I have a set in my hiking boots,
my trail shoes, and my everyday dress shoes these things are so great.
Best knee savers!, January 4, 2010
By Beauty Maven “steph” (San Diego, CA)
This review is from: Spenco® PolySorb® Cross Trainer Insoles (Apparel)
I run about 30 miles a week. I wear Nike trail running shoes and I've had them for about
a year. Not wanting to purchase new shoes, I thought I'd just remove the insoles and try
these Spenco's. I cannot BELIEVE what a difference they've made! My joints don't ache
at all and my lower back never gives me any grief now. The only thing I've changed are
the insoles of my shoes...not the terrain I run on, or the speed or my distance so I can
only assume my Spenco's are to "blame". :)
Page 15 of 26
7. Pedag
Pedag insoles are either made of natural materials like vegetable-tanned cow
hide, sheepskin, cotton, sisal, charcoal or wool which allow the foot and shoe to
"breathe," or a polypropylene orthotic foot bed, latex or moss rubber pads are
encased in these materials. Pedag adhesives are water, not petroleum, based.
Many insoles use active carbon filters or nano sized silver ions to prevent the
growth of bacteria and odors. Pedag gels have been tested and approved for
prolonged contact with human skin.
Product Description
Pedag Viva Summer: Viva Summer updates Pedag Vitality as Pedag's orthotic
foot support for all warm weather activities. Like Pedag Vitality, Viva Summer
has an orthotic footbed with semi-rigid longitudinal arch and plantar support,
metatarsal pad and heel cushion pad. Viva Summer claims to help with the
prevention and relief of foot conditions such as Plantar Fasciitis and
Metatarsalgia. Viva Summer is designed for warm weather because it is made
with natural, absorbent, breathable fibers which keep feet fresh and comfortable.
Viva Summer uses nano sized silver ions that provide permanent, skin safe antimicrobial action. Viva Summer is gently hand washable. Viva Summer has been
awarded the American Podiatric Medical Association (APMA) Seal of Acceptance
for promoting foot health.
Product Details
•
•
•
•
•
•
Product Dimensions: 12 x 4.5 x 0.5 inches
Shipping Weight: 3.2 ounces (View shipping rates and policies)
Shipping: This item is also available for shipping to select countries
outside the U.S.
ASIN: B001E6QBK2
Item model number: Art 18306 US Women's 9 European Size 39
Price: $16.95
It seems to work well, March 22, 2011
Page 16 of 26
By E. Ament (Kentucky)
This review is from: Pedag Viva Summer (Vitality) Warm Weather Orthotic w/
Semi-Rigid Arch, Met & Heel Pad, Met & Heel Pad, US M11/EU44 (Health and
Beauty)
General sizing-It fits very well, even in wide width shoes. I got an 11 and I wear a 10
1/2. Personal experience-Very comfortable in a sturdy way. The arch doesn't push up on
my feet, which is a problem with my new Skechers shoes. The metarsal pad kind of
pushes against my left foot, but not to the point that it bothers me. I can't wear heel
cups with it. The front crinkles up with heel cups. You can go without socks with the
material, but don't do too much exercise or activity sockless. Not pretty (smelling) as I
tried with the Deo Fresh insoles, which uses the same terry cloth.
Comfortable!, February 28, 2009
By KF "comfort guru" (North Idaho)
This review is from: Pedag Viva Summer (Vitality) Warm Weather Orthotic w/
Semi-Rigid Arch, Met & Heel Pad, US W7/EU37 (Health and Beauty)
There are plenty of heel inserts out there but very few products for people with forefoot
problems like me! The Pedag 18306 Orthotic is full length and has a wonderful
metatarsal pad and arch support I could slip right into my boot and go. I plan on getting
another set.
Page 17 of 26
8. California Orthotics Inc., Yorthotics
History
Research into biomechanics of the feet was quite extensive in California in the
late 1960's. Professors at the California College of Podiatric Medicine were
researching the biomechanics of foot function and began to understand how
abnormal foot structure was causing foot problems.
They studied pronated (flat) feet and rigid high arched feet and devised methods
to correct these imbalances with orthotics. They knew they had to control the
subtalar joint motion. (The subtalar joint is the joint beneath the ankle joint).
In the early 1970's the running boom saw runners develop a lot of foot, leg and
knee problems.
Traditional treatment with rest, exercises, ice, massage or pills calmed
symptoms down until runners got back into their running and their problems
recurred. Abnormal foot mechanics were found to be the missing link. Around
that time, Dr. George Sheehan, a cardiologist and runners' guru discovered that
his knee pain was finally resolved with the use of a podiatrist's orthotics. He had
written many articles and books that sent runners to podiatrists' offices in
droves.
Orthotics were found to be the key to correcting the causes of many foot, leg
and knee problems and word of success with orthotics spread from California
across the nation.
By the 1980's, ski boot shops were fitting skiers with orthotics for their ski boots.
They may not have been as accurate as proper orthotics, but the foot beds were
helpful nonetheless.
Orthotics were being used successfully across the U.S. and Canada and from
California they spread to become a household word.
Product Description
California Orthotics Inc. foot health information has been compiled from current
research in the field of Podiatric Medicine.
The laboratory that California Orthotics Inc uses to fabricate orthotics has been
producing quality orthotics since 1977. They have been successful because they
strictly adhere to the principles of biomechanics that were established in
California a decade before. The lab makes orthotics for podiatrists in Canada, the
U.S. and the United Kingdom.
Yorthotics.com provides a unique (and free) self assessment that you can use to
get an excellent idea as to what may be going on with your feet.
This application enables the lab to have an excellent idea as to what is going on
biomechanically, and based on their years of experience in the orthotics
fabrication industry, they claim that they can produce orthotics that will work
well for many years to come.
Page 18 of 26
Product
CLAIMS
• For all sports shoes, for women and men, and will fit all men's shoes.
• This orthotic will go right on top of insole of sports shoes.
• Orthotics are versatile enough to switch from dress shoes to sports shoes.
• May fit in women's slip on shoes.
• Can be used with many types of sandals. (place a velcro sticker under
heel of orthotic for use in sandals.)
• thin profile
• well cushioned with flexibility
• long lasting and durable
• Price: $349.00
Page 19 of 26
9. Comparison Table
IsoPED
Footmaxx
SPENCO
Pedag
Yorthotics
Cost
$170
$275-$325
$19.99
$16.95
$349
Weight per pair
4.8 Ounces
4 Ounces
5.3 Ounces
3.2 Ounces
UNKNOWN
No
Yes
Pre-Made
Custom
Step by step
Yes
process custom
made to your feet?
Yes
How is the product Custom
made?
Custom
If Custom made.
What system is
used?
Sensor Based.
Diagnostic
Computerized
Gait system
Digitized data N/A
translated
through the
Metascan
system
N/A
Foot
Impression Kit
Delivery Time
1-2 Weeks
1-2 Weeks
1 Week
1 Week
1-2 Weeks
Initial comfort of
Immediate
Product - how fast Comfort
do they work?
Immediate
Comfort
Takes time to Takes time to Immediate
adjust
adjust
Comfort
When will you need 3-5 years
to replace the
product?
3-5 years
1 year
1 year
3-5 years
Effectiveness after Keep Shape
One Year of wear?
Keep Shape
Lose
Correction
Lose
Correction
Keep Shape
No
Pre-Made
Page 20 of 26
10. Does the IsoPED Insole reduce lower
extremity injuries?
<Insert information from test results>
Page 21 of 26
11. Can the RSscan footscan D3D orthotic reduce
lower limb injury in an initial Military training
setting?
1.
Introduction
Lower limb injuries are common in initial military training (1,2). Institute of
Naval Medicine studies at Commando Training Centre Royal Marines show a
lower limb injury rate of 36% (3,4). Running has been demonstrated to be a
significant cause of over use injuries as demonstrated that in any 12 month
period between 30 and 70% of both recreational and competitive runners sustain
injuries (5,6). Unpublished data (7) from Britannia Royal Naval College reports a
lower limb injury rate of 27% (n=280) with respect to diagnoses Anterior Knee
Pain, Ilio-tibial band syndrome, Patello-femoral disorder, Medial tibial stress
syndrome, Stress fracture tibia/ metatarsal, Plantar fasciitis, Achilles
tendonopathy. Any method of reducing injuries in initial training is of great
interest both in terms of public health, andindividual morbidity and career
success.
2.
Aim
The aim of this study was to determine whether the footscan® prescribed D3D™
orthotic reduced injury in the target population:
P - male military new entry trainees assessed as high or medium risk of injury
I - prescription of the D3D™
C - no intervention
O - change in incidence of injury, as determined by the outcome measure of 2 or
more lost training days
3.
Methods
400 male participants gave written informed consent. Participants were asked to
walk across the 18m track of 0.02m EVA covered in a 0.005m rubber track, at a
natural gait. 5 recordings of both right and left foot plantar pressure data were
taken using the RS Scan International plate 1m x 0.4m x 0.02m, 64 lines at
500Hz and 4 sensors per cm2 (Total of 8192 resistive sensors)
Page 22 of 26
The footscan® system works by measuring vertical force over a number of
sensors (8192 sensors on a 1m plate). This allows the pressure to be calculated
by knowing the area that the force is being applied over. The system measures
the vertical force that is applied by the body through the foot to the ground
during the stance phase.
By dividing this contact up into different foot zones, the system can look at
maximum pressures/forces applied in these different areas, and the timing of
this application of force. This allows a detailed analysis of when/where force is
being applied during the stance phase. If there is an imbalance occurring in any
of these key stages, the D3D™ section of the software will highlight where the
imbalance is, and the type of correction suggested.
The recommended orthotic prescription, if applicable, was graded (Fig.2) and
those at high and medium risk were randomized to either receive a custom
D3D™ orthotic or no intervention.
HIGH
One or more corrections suggested
by D3DTM on BOTH feet
MEDIUM
MEDIUM One correction suggested by
D3DTM on ONE foot
Page 23 of 26
LOW
No Correction
Participants were followed up after the 14 week initial training phase for lower
limb injury. Definition of injury was a lower limb injury resulting in missing
training for 2 days or more, excluding ankle inversion injury.
4.
Ethics
The study went ahead with Human Ethical approval from the Ministry of Defence
Research Ethics Committee Registration 0727/112. Full compliance with Data
Protection Act and Caldicott Confidentiality Guidance.
5.
Inclusion/Exclusion
All new entry officers were given a presentation on the trial and given the
opportunity to take part, as part of their joining procedure. Participants were
excluded if they had existing orthotic prescription (n=3), declared existing lower
limb injury (n=2) or withdrew their consent (n=1).
6.
Results
Group
Category
N/640
Injury(n=82)
%
Control
High/Medium
200
49
59
Orthotic
High/Medium
200
8
9
Background
Low/No Risk
240
25
32
Absolute Risk Reduction
0.59-0.09 = 0.50 (50%)
Number needed to treat
1/0.50 = 2
7.
Statistical analysis
Pilot studies suggested, using the background injury rate of 17% that the
sensitivity and specificity were 87% and 69% respectively. Power calculations
were performed to a sample size of 400 was sufficient to detect difference
between groups for p<0.05 with 80% power. PASS software (2005) was used
and McNemar’s test was applied to correlated data. Statistical analysis was
performed using the SPSS statistical package Version 15.0 (SPSS inc, Chicago,
Page 24 of 26
Ill, USA). Fischer’s test was used for non parametric data and confirmed a
significant difference between the two cohorts (P<0.01)
8.
Discussion
As far as the author’s are aware, this is the first randomised controlled trial to
compare orthotic use with a view to reduction of injury. Numerous studies have
been completed in the quest of physical, measurable factors predictive of injury
in sports. These include flexibility (8), joint laxity (9,10) and biomechanical
variables (11,12,13). Although none of these have successfully allowed
prevention of injury. In shoe orthotic devices raise much discussion in the
Sports Medicine world as to whether they can confer an actual change in
kinematics. Nigg has published extensively on the actual benefit of orthoses and
suggests (14,15) that the true benefit is not in producing a rigid control or
reduction in range of motion, but in the change of muscle use to modify
kinematics. The authors would agree that it would appear that the increased
muscle activation of lower limb stabilisers that contribute to the reduced injury
rate.
9.
Limitations
The subjects were not blinded as to the nature of the insole, although the end
point of the study was reporting of injury. The thickness and structure of any
dummy ‘non prescription’ insole was felt to add too great a confounding variable
as this would contribute to altered kinematics.
The non intervention group were unaware of their status as to low risk on
control.
10.
Conclusions
Prescription of the D3DTM orthotic reduced injury rate (ARR) by 31% in those
categorised as High and medium risk. This gave NNT of 3.2. In an Initial Military
training population, the footscan® D3DTM orthotic device is able to
significantly (P<0.01) reduce lower limb injury.
11.
References
1. Strowbridge, N.F. Musculoskeletal injuries in female soldiers: analysis
2.
3.
4.
5.
6.
7.
of cause and type of injury. J R Army Med Corps. 148:256-8, 2002.
Yates, B., and S. White. The incidence and risk factors in the development
of medial tibial stress syndrome among naval recruits. Am J Sports Med.
32:772-80, 2004.
Evans, G. Stress fractures at Commando Training Centre Royal Marines. A
retrospective survey. Journal of the Royal Naval Medical Service. 68:72-81, 1982.
Pullinger, N. CTCRM Injury Study. In: Research Committee Meeting.
Alverstoke, UK: Institute of Naval Medicine, 1999.
Marti, B., and P. Vader. On the Epidemiology of running injuries: the 1984
Berlin GrandPrix Study. American Journal of Sports Medicine. 16:285-293, 1998.
Rochconger, P., F. Pennes, and Carne. Occurrence of running injuries.
Sci. Sports. 10:15-19, 1995.
Franklyn-Miller, A. Injury and Illness rates at Britannia Royal Naval
Page 25 of 26
College 2005-2006. Dartmouth, UK: Britannia Royal Naval College, 2006.
8. Steele, V.A., and J.A. White. Injury prediction in female gymnasts.
Br J Sports Med. 20:31-3, 1986.
9. Godshall, R.W. The predictability of athletic injuries: an eight-year
study. J Sports Med. 3:50-4, 1975.
10. Nicholas, J.A. Injuries to knee ligaments. Relationship to looseness and
tightness in football players. Jama. 212:2236-9, 1970.
11. Grubbs, N., R.T. Nelson, and W.D. Bandy. Predictive validity of an injury
score among high school basketball players. Med Sci Sports Exerc.
29:1279-85, 1997.
12. Messier, S.P., and K.A. Pittala. Etiologic factors associated with selected
running injuries. Med Sci Sports Exerc. 20:501-5, 1988.
13. Ross, C.F., and R.O. Schuster. A preliminary report on predicting injuries
in distance runners. J Am Podiatry Assoc. 73:275-7, 1983.
14. Nigg, B.M. The role of impact forces and pronation: a new paradigm.
Clin J Sports Med. 11:2-9, 2001.
15. Nigg, B.M., and M. Nurse. Shoe inserts and orthotics for sports and
physical activity. Med Sci Sports Exerc. 31:5421-8, 1999.
Page 26 of 26

IsoPED Comparative Analysis

Transcription

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