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It has been quite awhile since I have had a chance to write in...I

would like to share some things Ihave been learning since I last

wrote...Through our holistic approach we have discovered that our

entire family, especially our daughter with the delays, have

been " encoded " by all of the lights, electronic security systems, etc

that is society today. All of our cells and organs have had little

blockages put up in our system from these devices which have been

contributing to a lot of the health issues going on. Since we have

been unecoded, things are improving, our daughter has gotten stronger

and is more active, her organs are functioning better and she is

absorbing more nutrients and putting on weight...her calcium levels

which had been way to high since birth are now back within the normal

limits (just this last month), and she is even standing on her feet

again and we are working with her to start moving her feet towards

being able to walk (she is 25months old)She is even making more

sounds than she has ever made and her apraxia speech therapist said

it should only be a matter of time for her to start using words

becuase she is mimicing mouth movements but now she has to put the

sound and the movement together. Another thing I have found out is

that there is a device for kids with hypotonia, delayed skills,

speech included, called Suit therapy that can help the kids overcome

the delays. It isn't guaranteed for everyone but it has shown great

improvement for a lot of kids. If you do a search for suit therapy,

there is a place in FL and MI that have centers that will train the

parents so you can do home therapy or you can go to the centers for

intense 3-5wks of therapy...we are having our daughter try the suit

come May to see if it will take her to the next level, they feel she

is a very good candidate. We originally called MI and spoke with the

people there, filled out the paperwork and then they called us to let

us know whether or not she would be considered a candidate...Our

regular doctors knew nothing of this method but will be learning

through our experience...Fair warning it is pricey but we are getting

state monies to help supplement the payments...The last thing we have

found out is that our entire family has had issues with parasites in

our systems that have also been interferring with our abilities to

get " better " , so much to the point that sleep patterns have been

goofey, and we have been passing them back and forth from just

drinking from each others glasses etc...Now that our systems are

cleaned out, we are all doing better. My husband is actually having

his diabetic medications reduced so that he doesn't have to take as

many...Food for thought if you seem to be getting no where with the

traditional medical professionals...try the holistic approach and

find a good kinesthesilogist and check out Premier Labs...they have

talk show educational times on the radio and staff on the phone that

are great at answering questions...Hang in there everyone and fight

for what your gut tells you too...you know your families the best!

Debbie & Cadyn

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Hi Debbie!

When you first joined 8 months ago you wrote about your 17 month old

having trouble sitting up due to her hypotonia. Lightbulbs aside -

how is she today in regards to her motor skills and speech?

Most of us here do follow some type of holistic approach to health -

but don't know if many go to the extremes you are exploring which is

why most of the messages you have written get few if any responses

here. Like when you posted about applied kinesiology -most here

don't practice that either -and actually there are studies in the US

and Germany that say that method is no better than guessing.

I don't know much about encoding -but even if that was an issue -how

do you keep your child and family " normal " if you leave your home?

What type of parasites did your entire family have?

(what type of doctor diagnosed this if it was a medical doctor?)

(is it contagious?)

And Suit therapy -here's Cigna Healthcare's report on why they won't

cover it for any condition:

Page 1 of 6

Coverage Position Number: 0353

CIGNA HEALTHCARE COVERAGE POSITION

Subject Suit Therapy

Revised Date ............................. 5/15/2007

Original Effective Date ............. 5/15/2005

Coverage Position Number ............. 0353

Table of Contents

Coverage Position............................................... 1

General Background ........................................... 1

Coding/Billing Information ................................... 4

References.......................................................... 4

Hyperlink to Related Coverage Positions

Botulinum Toxin Type A (Botox® A)

Gait Analysis

Neurosurgical Treatment of Spasticity

Physical Therapy

INSTRUCTIONS FOR USE

Coverage Positions are intended to supplement certain standard CIGNA

HealthCare benefit plans. Please note, the terms of a

participant's particular benefit plan document [Group Service

Agreement (GSA), Evidence of Coverage, Certificate of Coverage,

Summary Plan Description (SPD) or similar plan document] may differ

significantly from the standard benefit plans upon which

these Coverage Positions are based. For example, a participant's

benefit plan document may contain a specific exclusion related to

a topic addressed in a Coverage Position. In the event of a conflict,

a participant's benefit plan document always supercedes the

information in the Coverage Positions. In the absence of a

controlling federal or state coverage mandate, benefits are ultimately

determined by the terms of the applicable benefit plan document.

Coverage determinations in each specific instance require

consideration of 1) the terms of the applicable group benefit plan

document in effect on the date of service; 2) any applicable

laws/regulations; 3) any relevant collateral source materials

including Coverage Positions and; 4) the specific facts of the

particular

situation. Coverage Positions relate exclusively to the

administration of health benefit plans. Coverage Positions are not

recommendations for treatment and should never be used as treatment

guidelines. ©2007 CIGNA Health Corporation

Coverage Position

CIGNA HealthCare does not cover suit therapy for the treatment of any

condition including, but

not limited to, cerebral palsy or other neuromuscular conditions,

because it is considered

experimental, investigational or unproven.

General Background

Cerebral palsy is a term used to describe a group of chronic

disorders that impair the control of movement

and that appear in the first few years of life. It is not

progressive. Cerebral palsy is classified according to

the type of movement disorder and which limb or limbs are affected.

The four broad categories include

(Rudolph, 2003; National Institute of Neurological Disorders and

Stroke [NINDS], 2006):

• Spastic: In this form, the patient exhibits upper motor neuron

signs, such as weakness,

hypertonicity, hyperreflexia, clonus, pathologic reflexes and a

tendency to contractures. This type

affects 70–80% of patients with cerebral palsy and is further

classified as to the limb impairment

and includes:

& #56256; & #56510; quadriplegia, the symmetric impairment of all four extremities

& #56256; & #56510; diplegia, in which the bilateral spasticity of the legs is

greater

than that of the arms

& #56256; & #56510; monoplegia, a rare type in which only one limb is involved

& #56256; & #56510; paraplegia, involving only the lower extremities

& #56256; & #56510; triplegia, a rare type, with only one unaffected limb

Page 2 of 6

Coverage Position Number: 0353

• Athetoid, or dyskinetic: This form includes uncontrolled, slow,

writhing movements. These

movements may affect the hands, feet, arms or legs and, in some

cases, the face and tongue,

which may also affect speech, causing dysarthria.

• Ataxic: This is a rare form, affecting the sense of balance and

depth perception.

• Mixed forms: It is common for patients to have symptoms of more

than one of the three previous

forms. The most common mixed form includes spasticity and athetoid

movements.

Patients may also experience impairments beyond the neuromuscular

involvement, such as mental

impairment, seizures, visual and auditory dysfunction, growth

problems, and abnormal sensation and

perception. The orthopedic difficulties encountered in children with

cerebral palsy are frequently a result

of high muscle tone, spasticity, and rigidity that prevent normal

growth of muscle and cause contractures.

Treatment of functional deficits associated with cerebral palsy

usually applies a multidisciplinary approach

and may include physicians of various specialties, occupational

therapists, physical therapists, speech

pathologists, social workers, and developmental psychologists. The

treatment plan may include physical

therapy, surgery, drug therapy, and/or mechanical aids and is

tailored to the unique needs and

impairments of each patient. The therapy is focused on decreasing the

degree of impairment (e.g.,

muscle spasticity) and increasing participation in activities of

daily living. Therapists in the disciplines of

physiotherapy, occupational therapy, and speech therapy utilize

physical and behavioral approaches

aimed at lengthening contracted muscles, improving the strength of

weakened muscles, increasing the

range of motion at restricted joints, improving movement

coordination, and developing compensatory

strategies to accomplish tasks (United Cerebral Palsy [uCP], 2003).

Suit therapy has been proposed as an alternative to conventional

physiotherapy to treat the impairments

associated with cerebral palsy. This therapy is based on a suit

originally designed by the Russians for use

by cosmonauts in space to minimize the effects of weightlessness. The

idea is to move body parts

against a resistance, thus improving muscle strength. Through

placement of the elastic cords, selected

muscle groups can be exercised as the patient moves limbs; thus, suit

therapy is a form of controlled

exercise against a resistance. It is also claimed that the suit

improves coordination. The suit consists of a

cap, a vest, shorts, knee pads, and shoes. An attached series of

elastic cords provides compression to

the body's joints and resistance to muscles when movement occurs.

Suit therapy is often used as part of

a comprehensive program of intensive physiotherapy of 5–7 hours a day

for four weeks (UCP, 1999).

The therapy suit is also known as the Adeli® suit (Ayurveda JS Co.,

Moscow, Russia), the TheraSuit™

(Therasuit LLC, Keego Harbor, MI), the NeuroSuit (Neurosuit LLC,

Hiram, GA) and the Penguin suit. Suit

therapy first started in clinics in Europe in the early 1990s.

Currently, suit therapy is rendered at many

physical therapy centers in the United States. Suit therapy has been

proposed primarily as a treatment for

cerebral palsy, but the manufacturer of the TheraSuit also recommends

the treatment for other

neuromuscular disorders, including developmental delays, traumatic

brain injury, post-stroke, ataxia,

athetosis, spasticity, and hypotonia.

The manufacturer of the TheraSuit proposes that suit therapy will

provide the following benefits:

• retrain central nervous system

• restore ontogenic development

• provide external stabilization

• normalize muscle tone

• align the body to as close to normal

• provide dynamic correction

• normalize gait pattern

• provide tactile stimulation

• influence the vestibular system

• improve balance

• improve coordination

• decrease uncontrolled movements in ataxia and athetosis

• improve body and spatial awareness

• support weak muscles

• provide resistance to strong muscles to further enhance

strengthening

Page 3 of 6

Coverage Position Number: 0353

• improve speech production and fluency through head control and

trunk support

• promote development of both fine and gross motor skills

• improve bone density

• help decrease contractures

• help improve hip alignment through vertical loading over hip joint

U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) classifies the Adeli

therapy suit and similar devices (e.g.,

therapy suit, Penguin suit, TheraSuit, NeuroSuit) as Class I limb

braces or orthosis.

Literature Review

There are no published studies indicating which subset of patients

may benefit from these devices or how

long the results might last. In addition, there are no studies that

demonstrate the relative safety and

effectiveness of suit therapy compared to conventional physiotherapy

treatment for the treatment of

cerebral palsy.

Bar-Haim et al. (2006) conducted a study to compare the efficacy of

Adeli suit treatment (AST) with

neurodevelopmental treatment (NDT) in children with cerebral palsy.

Twenty-four children with cerebral

palsy were matched by age and functional status and randomly assigned

to the AST or NDT treatment

groups. In the AST group (n=12) six children had spastic/ataxic

diplegia, one triplegia and five had

spastic/mixed quadriplegia. In the NDT group (n=12) five children had

spastic diplegia and seven had

spastic/mixed quadriplegia. Treatment was for two hours daily, five

days per week over four weeks for a

total of 20 sessions. Outcome measurements included the Gross Motor

Function Measure (GMFM-66)

and the mechanical efficiency index (EIHB). These were measured

during stair-climbing, at baseline,

immediately after one month of treatment, and 10 months after

baseline. There was an increase in both

the GMFM-66 and EIHB noted at one month for both intensive

physiotherapy courses. This increase

appeared to be greater than expected from natural maturation of

children with cerebral palsy at this age.

It was noted that the improvements in motor skills and their

retention nine months after treatment were

not significantly different between the two treatment modes. A post

hoc analysis indicated a greater

increase in EIHB after one month and 10 months in the AST group than

that in the NDT group. This was

noted to be more predominant in the children with higher motor

function. The authors conclude that " The

results suggest that AST might improve mechanical efficiency without

a corresponding gain in gross

motor skills, especially in children with higher levels of motor

function. " The authors note that, " Future

studies on the efficacy of AST should measure changes in metabolic

efficiency and fitness level, as well

as motor skills. It is also important to determine changes induced by

the suit itself, by having two groups

perform the same physical training, with and without the suit. Future

studies should increase the number

of participants and homogenize the participants with CP [cerebral

palsy] to reduce variability. "

Liptak (2005) conducted a review of nine complementary and

alternative therapies for cerebral palsy.

Regarding the use of the Adeli suit, the review noted that " no

published evidence from a controlled trial is

available in English to support or reject the use of the suit. Thus,

no conclusive evidence either in support

of or against the use of the Adeli suit is available. "

The United Cerebral Palsy (UCP) Research and Education Foundation has

published two research fact

sheets on the Adeli suit. The first was published in March 1999, at

which time suit therapy was only

provided at facilities in Poland. Due to interest in suit therapy,

the November 2004 UCP fact sheet

reported on two studies funded by the UCP Research and Educational

Foundation.

The first study noted in the UCP research fact sheet was conducted by

Dr. in Israel. The

study involved 24 children between ages six and 12 years with

cerebral palsy. The patients were

randomly assigned either to a standard physical therapy program or to

the Adeli suit using the original

Russian protocol. Both groups were treated with a two-hour session,

five days a week. Evaluation of a

number of parameters showed marginal improvement in both groups that

persisted over the following

year. There was no statistical difference between the children who

used the Adeli suit and those who did

not (UCP, 2004).

Page 4 of 6

Coverage Position Number: 0353

The second study noted in the fact sheet was conducted by Dr.

Dabrowski at the Children's

Hospital of Michigan. This study involved 57 children who were

randomized to control and treatment

groups. All children received one hour each of physical, occupational

and speech therapy three times a

week for 8–10 weeks, followed by a four-week home program. The

experimental group wore the Adeli

suit for the last four weeks of their therapy program. It was noted

that both groups improved and

sustained the improvement but without any statistical difference

between the two groups (UCP, 2004).

The UCP research fact sheet concluded that these studies show that a

period of intensive therapy in

ambulatory children with cerebral palsy can lead to improvement in a

number of disabilities. However,

they did not demonstrate that the use of the Adeli suit was helpful,

and they reported that any effect is

likely to be minor.

Summary

There is insufficient evidence in the published, peer-reviewed

scientific literature to establish the safety

and effectiveness of suit therapy for the treatment of functional

impairments associated with cerebral

palsy or other neuromuscular disorders. Well-designed clinical trials

are needed to demonstrate that this

treatment is as effective as conventional physiotherapy in the

treatment of cerebral palsy or other

neuromuscular disorders, that it improves patients' functional

abilities and activities of daily living, and that

it decreases impairment.

Coding/Billing Information

Note: This list of codes may not be all-inclusive.

Experimental/Investigational/Unproven/Not Covered:

CPT* Codes Description

97139 Unlisted therapeutic procedure (specify)†

HCPCS

Codes

Description

No specific codes

ICD-9-CM

Diagnosis

Codes

Description

343.0-343.9 Infantile cerebral palsy

Multiple/varied

†Note: Experimental/investigational/unproven and not covered when

used to report Suit Therapy

for the treatment of any condition, including but not limited to

cerebral palsy or other

neuromuscular conditions

*Current Procedural Terminology (CPT®) ©2006 American Medical

Association: Chicago, IL.

References

1. Adeli Project [information on the Adeli approach]. Ayurveda JS Co.

Accessed March 26, 2007.

Available at URL address: http://www.adeli-suit.com/English/index.htm

2. Adeli Suit [product information]. Euromed. Accessed March 26,

2007. Available at URL address:

http://www.euromed.pl/en/index.php?ppg=adeli_suit:suit

Page 5 of 6

Coverage Position Number: 0353

3. Ashwal S, Russman BS, Blasco PA, G, Sandler A, Shevell M,

son R; Quality

Standards Subcommittee of the American Academy of Neurology; Practice

Committee of the

Child Neurology Society. Practice parameter: diagnostic assessment of

the child with cerebral

palsy: report of the Quality Standards Subcommittee of the American

Academy of Neurology and

the Practice Committee of the Child Neurology Society. Neurology.

2004 Mar 23;62(6):851-63.

4. Bar-Haim S, Harries N, Belokopytov M, A, Copeliovitch L,

Kaplanski J, Lahat E.

Comparison of efficacy of Adeli suit and neurodevelopmental

treatments in children with cerebral

palsy. Dev Med Child Neurol. 2006 May;48(5):325-30.

5. Behrman RE, Kliegman RM, Jenson HB, editors. textbook of

pediatrics. 17th ed.

Philadelphia, PA: W.B. Saunders Company; 2004. p. 2024-5.

6. Canale T, editor. 's operative orthopaedics. 10th ed. St.

Louis, MO: Mosby, Inc.; 2003. p.

1218-23.

7. DeLuca PA. The musculoskeletal management of children with

cerebral palsy. Pediatr Clin North

Am. 1996 Oct;43(5):1135-50.

8. U.S. Food and Drug Administration (FDA). Code of federal

regulations; title 21, vol. 8; subchapter

H (medical devices); part 890 (physical medicine devices); subpart D

(physical medicine

prosthetic devices); sec. 890.3475]. Limb orthosis. Revised 2004 Apr

1. Accessed March 26,

2007. Available at URL address:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/search.cfm?

db=CFR & id=890.3475

9. Goldstein M. The treatment of cerebral palsy: what we know, what

we don't know. J Pediatr. 2004

Aug;145(2 Suppl):S42-6.

10. Hurvitz EA, Leonard C, Ayyangar R, VS. Complementary and

alternative medicine use in

families of children with cerebral palsy. Dev Med Child Neurol. 2003

Jun;45(6):364-70.

11. Liptak GS. Complementary and alternative therapies for cerebral

palsy. Ment Retard Dev Disabil

Res Rev. 2005;11(2):156-63.

12. Michaud LJ; American Academy of Pediatrics Committee on Children

With Disabilities.

Prescribing therapy services for children with motor disabilities.

Pediatrics. 2004 Jun;113(6):1836-

8.

13. NINDS cerebral palsy information page. National Institute of

Neurological Disorders and Stroke

(NINDS). Bethesda, MD: NINDS, National Institutes of Health (NIH).

Last update: January 25,

2006. Accessed March 26, 2007. Available at URL address:

http://www.ninds.nih.gov/disorders/cerebral_palsy/detail_cerebral_pals

y.htm

14. NOMC [North Oakland Medical Centers] Euro-Pçds program: SUIT

therapy. 2004. Accessed

March 26, 2007. Available at URL address:

http://www.europeds.org/epp_st.htm

15. Rosenbaum P. Cerebral palsy: what parents and doctors want to

know. BMJ. 2003

May 3;326(7396):970-4.

16. Rudolph CD, Rudolph AM, Hostetter MK, Lister GE, Siegel NJ,

editors. Rudolph's pediatrics. 21st

ed. New York, NY: McGraw-Hill; 2003. Ch. 25.

17. Suit therapy for cerebral palsy [information about the TheraSuit

Method™ and the TheraSuit™].

Therasuit LLC. Accessed March 26, 2007. Available at URL address:

http://www.suittherapy.com/

18. United Cerebral Palsy (UCP). The Adeli Suit [research fact sheet:

diagnosis/treatment].

Washington, DC: United Cerebral Palsy (UCP) Research & Educational

Foundation; 1999 Mar.

Page 6 of 6

Coverage Position Number: 0353

Accessed March 26, 2007. Available at URL address:

http://www.ucp.org/ucp_generaldoc.cfm/1/4/24/24-6608/82

19. United Cerebral Palsy (UCP). The Adeli Suit Update [research fact

sheet]. Washington, DC:

United Cerebral Palsy (UCP) Research & Educational Foundation; 2004

Nov. Accessed March

26, 2007. Available at URL address:

http://www.ucp.org/ucp_generaldoc.cfm/1/4/24/24-24/5896

20. United Cerebral Palsy (UCP). The Treatment of Cerebral Palsy

[research status report].

Washington, DC: United Cerebral Palsy (UCP) Research & Educational

Foundation; 2003 Jun.

http://www.cigna.com/.../coverage_positions/medical/mm_0353_coveragepo

sitioncriteria_suit_therapy.pdf

=====

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Guest guest

Thank you for the information on the insurance...we are just getting

into that end of things now and will see where we end up, although

from what I have been told, her state medical card should pick up a

chunk of the expenses. The suit will be used in conjunction with all

of her regular therapies, it will be used to enhance what they are

already doing...The suit method isn't for everyone, the kids do have

to " pass " certain medical criteria before it will even be tried as an

option...

As for Cadyn's sitting, she is doing great and her motor skills are

showing greater signs of improvement over the last month or so, but

we have been tackling her issues consistantly.

I understand that the kinesthesiology approach is controversial, but

then again in this country everything that is not considered

traditional medicine is questioned...look at the mercury issues for

teeth and vaccines...We are not the typical american in that we

practice both easterna nd Western medicine to get to the results we

are looking for, and with my science background I research everything

before we move ahead so that we have a certain level of confidence,

if that makes any sense, as I am sure it does based on the

discussions i have read here in this group...I believe everyone is

doing the same.

As for the encoding, we learned about it from Premier Research Labs

out of TX and once we were unencoded (they use a special laser light,

non invasive) and then we carry a small techtite (spelling?) in our

pockets that helps to create a barrier around us that works off the

electromagnetic fields within our bodies..it sounds sci fi but it

really isn't...

As for the types of parasites we have I do not have the names off

hand, they are in our files at home, but they found them through

testing of the intestinal track and stool and the kids have them

because I had them when they were born and of course the eggs

continue to go through the life cycles until you get them back under

control..Everyone has them, that much I do remember, but in our case

they have gotten out of control because of diet etc. One sign my

boys showed was a strong craving for sugars....now that theirs are

under control the sugar cravings have subsided and they are also

sleeping through the night, where as before they were up 2-3 times

each night and no one got any sleep. For Cadyn, the parasites were

eating the nutrients from her food before she had a chance to fully

utilize them herself and now that too has changed and she is gaining

weight and her doctors are happy...

I realize not many people respond to my posts, which is fine, because

I post so that if anything we have experienced can help someone else

then that is a great thing...it is just posted as possible options

because I know when we joined we were at a standstill and didn't know

where else to turn, and after reading posts we started trying things

and saw steps moving forward which we can never say thank you enough

for....

Debbie & Cadyn

>

> Hi Debbie!

>

> When you first joined 8 months ago you wrote about your 17 month old

> having trouble sitting up due to her hypotonia. Lightbulbs aside -

> how is she today in regards to her motor skills and speech?

>

> Most of us here do follow some type of holistic approach to health -

> but don't know if many go to the extremes you are exploring which is

> why most of the messages you have written get few if any responses

> here. Like when you posted about applied kinesiology -most here

> don't practice that either -and actually there are studies in the US

> and Germany that say that method is no better than guessing.

>

> I don't know much about encoding -but even if that was an issue -

how

> do you keep your child and family " normal " if you leave your home?

> What type of parasites did your entire family have?

> (what type of doctor diagnosed this if it was a medical doctor?)

> (is it contagious?)

>

> And Suit therapy -here's Cigna Healthcare's report on why they won't

> cover it for any condition:

>

> Page 1 of 6

> Coverage Position Number: 0353

> CIGNA HEALTHCARE COVERAGE POSITION

> Subject Suit Therapy

> Revised Date ............................. 5/15/2007

> Original Effective Date ............. 5/15/2005

> Coverage Position Number ............. 0353

> Table of Contents

> Coverage Position............................................... 1

> General Background ........................................... 1

> Coding/Billing Information ................................... 4

>

References.......................................................... 4

> Hyperlink to Related Coverage Positions

> Botulinum Toxin Type A (Botox® A)

> Gait Analysis

> Neurosurgical Treatment of Spasticity

> Physical Therapy

> INSTRUCTIONS FOR USE

> Coverage Positions are intended to supplement certain standard CIGNA

> HealthCare benefit plans. Please note, the terms of a

> participant's particular benefit plan document [Group Service

> Agreement (GSA), Evidence of Coverage, Certificate of Coverage,

> Summary Plan Description (SPD) or similar plan document] may differ

> significantly from the standard benefit plans upon which

> these Coverage Positions are based. For example, a participant's

> benefit plan document may contain a specific exclusion related to

> a topic addressed in a Coverage Position. In the event of a

conflict,

> a participant's benefit plan document always supercedes the

> information in the Coverage Positions. In the absence of a

> controlling federal or state coverage mandate, benefits are

ultimately

> determined by the terms of the applicable benefit plan document.

> Coverage determinations in each specific instance require

> consideration of 1) the terms of the applicable group benefit plan

> document in effect on the date of service; 2) any applicable

> laws/regulations; 3) any relevant collateral source materials

> including Coverage Positions and; 4) the specific facts of the

> particular

> situation. Coverage Positions relate exclusively to the

> administration of health benefit plans. Coverage Positions are not

> recommendations for treatment and should never be used as treatment

> guidelines. ©2007 CIGNA Health Corporation

> Coverage Position

> CIGNA HealthCare does not cover suit therapy for the treatment of

any

> condition including, but

> not limited to, cerebral palsy or other neuromuscular conditions,

> because it is considered

> experimental, investigational or unproven.

> General Background

> Cerebral palsy is a term used to describe a group of chronic

> disorders that impair the control of movement

> and that appear in the first few years of life. It is not

> progressive. Cerebral palsy is classified according to

> the type of movement disorder and which limb or limbs are affected.

> The four broad categories include

> (Rudolph, 2003; National Institute of Neurological Disorders and

> Stroke [NINDS], 2006):

> • Spastic: In this form, the patient exhibits upper motor neuron

> signs, such as weakness,

> hypertonicity, hyperreflexia, clonus, pathologic reflexes and a

> tendency to contractures. This type

> affects 70–80% of patients with cerebral palsy and is further

> classified as to the limb impairment

> and includes:

> & #56256; & #56510; quadriplegia, the symmetric impairment of all four

extremities

> & #56256; & #56510; diplegia, in which the bilateral spasticity of the

legs is greater

> than that of the arms

> & #56256; & #56510; monoplegia, a rare type in which only one limb is

involved

> & #56256; & #56510; paraplegia, involving only the lower extremities

> & #56256; & #56510; triplegia, a rare type, with only one unaffected

limb

> Page 2 of 6

> Coverage Position Number: 0353

> • Athetoid, or dyskinetic: This form includes uncontrolled, slow,

> writhing movements. These

> movements may affect the hands, feet, arms or legs and, in some

> cases, the face and tongue,

> which may also affect speech, causing dysarthria.

> • Ataxic: This is a rare form, affecting the sense of balance and

> depth perception.

> • Mixed forms: It is common for patients to have symptoms of more

> than one of the three previous

> forms. The most common mixed form includes spasticity and athetoid

> movements.

> Patients may also experience impairments beyond the neuromuscular

> involvement, such as mental

> impairment, seizures, visual and auditory dysfunction, growth

> problems, and abnormal sensation and

> perception. The orthopedic difficulties encountered in children with

> cerebral palsy are frequently a result

> of high muscle tone, spasticity, and rigidity that prevent normal

> growth of muscle and cause contractures.

> Treatment of functional deficits associated with cerebral palsy

> usually applies a multidisciplinary approach

> and may include physicians of various specialties, occupational

> therapists, physical therapists, speech

> pathologists, social workers, and developmental psychologists. The

> treatment plan may include physical

> therapy, surgery, drug therapy, and/or mechanical aids and is

> tailored to the unique needs and

> impairments of each patient. The therapy is focused on decreasing

the

> degree of impairment (e.g.,

> muscle spasticity) and increasing participation in activities of

> daily living. Therapists in the disciplines of

> physiotherapy, occupational therapy, and speech therapy utilize

> physical and behavioral approaches

> aimed at lengthening contracted muscles, improving the strength of

> weakened muscles, increasing the

> range of motion at restricted joints, improving movement

> coordination, and developing compensatory

> strategies to accomplish tasks (United Cerebral Palsy [uCP], 2003).

> Suit therapy has been proposed as an alternative to conventional

> physiotherapy to treat the impairments

> associated with cerebral palsy. This therapy is based on a suit

> originally designed by the Russians for use

> by cosmonauts in space to minimize the effects of weightlessness.

The

> idea is to move body parts

> against a resistance, thus improving muscle strength. Through

> placement of the elastic cords, selected

> muscle groups can be exercised as the patient moves limbs; thus,

suit

> therapy is a form of controlled

> exercise against a resistance. It is also claimed that the suit

> improves coordination. The suit consists of a

> cap, a vest, shorts, knee pads, and shoes. An attached series of

> elastic cords provides compression to

> the body's joints and resistance to muscles when movement occurs.

> Suit therapy is often used as part of

> a comprehensive program of intensive physiotherapy of 5–7 hours a

day

> for four weeks (UCP, 1999).

> The therapy suit is also known as the Adeli® suit (Ayurveda JS Co.,

> Moscow, Russia), the TheraSuit™

> (Therasuit LLC, Keego Harbor, MI), the NeuroSuit (Neurosuit LLC,

> Hiram, GA) and the Penguin suit. Suit

> therapy first started in clinics in Europe in the early 1990s.

> Currently, suit therapy is rendered at many

> physical therapy centers in the United States. Suit therapy has been

> proposed primarily as a treatment for

> cerebral palsy, but the manufacturer of the TheraSuit also

recommends

> the treatment for other

> neuromuscular disorders, including developmental delays, traumatic

> brain injury, post-stroke, ataxia,

> athetosis, spasticity, and hypotonia.

> The manufacturer of the TheraSuit proposes that suit therapy will

> provide the following benefits:

> • retrain central nervous system

> • restore ontogenic development

> • provide external stabilization

> • normalize muscle tone

> • align the body to as close to normal

> • provide dynamic correction

> • normalize gait pattern

> • provide tactile stimulation

> • influence the vestibular system

> • improve balance

> • improve coordination

> • decrease uncontrolled movements in ataxia and athetosis

> • improve body and spatial awareness

> • support weak muscles

> • provide resistance to strong muscles to further enhance

> strengthening

> Page 3 of 6

> Coverage Position Number: 0353

> • improve speech production and fluency through head control and

> trunk support

> • promote development of both fine and gross motor skills

> • improve bone density

> • help decrease contractures

> • help improve hip alignment through vertical loading over hip joint

> U.S. Food and Drug Administration (FDA)

> The U.S. Food and Drug Administration (FDA) classifies the Adeli

> therapy suit and similar devices (e.g.,

> therapy suit, Penguin suit, TheraSuit, NeuroSuit) as Class I limb

> braces or orthosis.

> Literature Review

> There are no published studies indicating which subset of patients

> may benefit from these devices or how

> long the results might last. In addition, there are no studies that

> demonstrate the relative safety and

> effectiveness of suit therapy compared to conventional physiotherapy

> treatment for the treatment of

> cerebral palsy.

> Bar-Haim et al. (2006) conducted a study to compare the efficacy of

> Adeli suit treatment (AST) with

> neurodevelopmental treatment (NDT) in children with cerebral palsy.

> Twenty-four children with cerebral

> palsy were matched by age and functional status and randomly

assigned

> to the AST or NDT treatment

> groups. In the AST group (n=12) six children had spastic/ataxic

> diplegia, one triplegia and five had

> spastic/mixed quadriplegia. In the NDT group (n=12) five children

had

> spastic diplegia and seven had

> spastic/mixed quadriplegia. Treatment was for two hours daily, five

> days per week over four weeks for a

> total of 20 sessions. Outcome measurements included the Gross Motor

> Function Measure (GMFM-66)

> and the mechanical efficiency index (EIHB). These were measured

> during stair-climbing, at baseline,

> immediately after one month of treatment, and 10 months after

> baseline. There was an increase in both

> the GMFM-66 and EIHB noted at one month for both intensive

> physiotherapy courses. This increase

> appeared to be greater than expected from natural maturation of

> children with cerebral palsy at this age.

> It was noted that the improvements in motor skills and their

> retention nine months after treatment were

> not significantly different between the two treatment modes. A post

> hoc analysis indicated a greater

> increase in EIHB after one month and 10 months in the AST group than

> that in the NDT group. This was

> noted to be more predominant in the children with higher motor

> function. The authors conclude that " The

> results suggest that AST might improve mechanical efficiency without

> a corresponding gain in gross

> motor skills, especially in children with higher levels of motor

> function. " The authors note that, " Future

> studies on the efficacy of AST should measure changes in metabolic

> efficiency and fitness level, as well

> as motor skills. It is also important to determine changes induced

by

> the suit itself, by having two groups

> perform the same physical training, with and without the suit.

Future

> studies should increase the number

> of participants and homogenize the participants with CP [cerebral

> palsy] to reduce variability. "

> Liptak (2005) conducted a review of nine complementary and

> alternative therapies for cerebral palsy.

> Regarding the use of the Adeli suit, the review noted that " no

> published evidence from a controlled trial is

> available in English to support or reject the use of the suit. Thus,

> no conclusive evidence either in support

> of or against the use of the Adeli suit is available. "

> The United Cerebral Palsy (UCP) Research and Education Foundation

has

> published two research fact

> sheets on the Adeli suit. The first was published in March 1999, at

> which time suit therapy was only

> provided at facilities in Poland. Due to interest in suit therapy,

> the November 2004 UCP fact sheet

> reported on two studies funded by the UCP Research and Educational

> Foundation.

> The first study noted in the UCP research fact sheet was conducted

by

> Dr. in Israel. The

> study involved 24 children between ages six and 12 years with

> cerebral palsy. The patients were

> randomly assigned either to a standard physical therapy program or

to

> the Adeli suit using the original

> Russian protocol. Both groups were treated with a two-hour session,

> five days a week. Evaluation of a

> number of parameters showed marginal improvement in both groups that

> persisted over the following

> year. There was no statistical difference between the children who

> used the Adeli suit and those who did

> not (UCP, 2004).

> Page 4 of 6

> Coverage Position Number: 0353

> The second study noted in the fact sheet was conducted by Dr.

> Dabrowski at the Children's

> Hospital of Michigan. This study involved 57 children who were

> randomized to control and treatment

> groups. All children received one hour each of physical,

occupational

> and speech therapy three times a

> week for 8–10 weeks, followed by a four-week home program. The

> experimental group wore the Adeli

> suit for the last four weeks of their therapy program. It was noted

> that both groups improved and

> sustained the improvement but without any statistical difference

> between the two groups (UCP, 2004).

> The UCP research fact sheet concluded that these studies show that a

> period of intensive therapy in

> ambulatory children with cerebral palsy can lead to improvement in a

> number of disabilities. However,

> they did not demonstrate that the use of the Adeli suit was helpful,

> and they reported that any effect is

> likely to be minor.

> Summary

> There is insufficient evidence in the published, peer-reviewed

> scientific literature to establish the safety

> and effectiveness of suit therapy for the treatment of functional

> impairments associated with cerebral

> palsy or other neuromuscular disorders. Well-designed clinical

trials

> are needed to demonstrate that this

> treatment is as effective as conventional physiotherapy in the

> treatment of cerebral palsy or other

> neuromuscular disorders, that it improves patients' functional

> abilities and activities of daily living, and that

> it decreases impairment.

> Coding/Billing Information

> Note: This list of codes may not be all-inclusive.

> Experimental/Investigational/Unproven/Not Covered:

> CPT* Codes Description

> 97139 Unlisted therapeutic procedure (specify)†

> HCPCS

> Codes

> Description

> No specific codes

> ICD-9-CM

> Diagnosis

> Codes

> Description

> 343.0-343.9 Infantile cerebral palsy

> Multiple/varied

> †Note: Experimental/investigational/unproven and not covered when

> used to report Suit Therapy

> for the treatment of any condition, including but not limited to

> cerebral palsy or other

> neuromuscular conditions

> *Current Procedural Terminology (CPT®) ©2006 American Medical

> Association: Chicago, IL.

> References

> 1. Adeli Project [information on the Adeli approach]. Ayurveda JS

Co.

> Accessed March 26, 2007.

> Available at URL address: http://www.adeli-

suit.com/English/index.htm

> 2. Adeli Suit [product information]. Euromed. Accessed March 26,

> 2007. Available at URL address:

> http://www.euromed.pl/en/index.php?ppg=adeli_suit:suit

> Page 5 of 6

> Coverage Position Number: 0353

> 3. Ashwal S, Russman BS, Blasco PA, G, Sandler A, Shevell M,

> son R; Quality

> Standards Subcommittee of the American Academy of Neurology;

Practice

> Committee of the

> Child Neurology Society. Practice parameter: diagnostic assessment

of

> the child with cerebral

> palsy: report of the Quality Standards Subcommittee of the American

> Academy of Neurology and

> the Practice Committee of the Child Neurology Society. Neurology.

> 2004 Mar 23;62(6):851-63.

> 4. Bar-Haim S, Harries N, Belokopytov M, A, Copeliovitch L,

> Kaplanski J, Lahat E.

> Comparison of efficacy of Adeli suit and neurodevelopmental

> treatments in children with cerebral

> palsy. Dev Med Child Neurol. 2006 May;48(5):325-30.

> 5. Behrman RE, Kliegman RM, Jenson HB, editors. textbook of

> pediatrics. 17th ed.

> Philadelphia, PA: W.B. Saunders Company; 2004. p. 2024-5.

> 6. Canale T, editor. 's operative orthopaedics. 10th ed. St.

> Louis, MO: Mosby, Inc.; 2003. p.

> 1218-23.

> 7. DeLuca PA. The musculoskeletal management of children with

> cerebral palsy. Pediatr Clin North

> Am. 1996 Oct;43(5):1135-50.

> 8. U.S. Food and Drug Administration (FDA). Code of federal

> regulations; title 21, vol. 8; subchapter

> H (medical devices); part 890 (physical medicine devices); subpart D

> (physical medicine

> prosthetic devices); sec. 890.3475]. Limb orthosis. Revised 2004 Apr

> 1. Accessed March 26,

> 2007. Available at URL address:

> http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/search.cfm?

> db=CFR & id=890.3475

> 9. Goldstein M. The treatment of cerebral palsy: what we know, what

> we don't know. J Pediatr. 2004

> Aug;145(2 Suppl):S42-6.

> 10. Hurvitz EA, Leonard C, Ayyangar R, VS. Complementary and

> alternative medicine use in

> families of children with cerebral palsy. Dev Med Child Neurol. 2003

> Jun;45(6):364-70.

> 11. Liptak GS. Complementary and alternative therapies for cerebral

> palsy. Ment Retard Dev Disabil

> Res Rev. 2005;11(2):156-63.

> 12. Michaud LJ; American Academy of Pediatrics Committee on Children

> With Disabilities.

> Prescribing therapy services for children with motor disabilities.

> Pediatrics. 2004 Jun;113(6):1836-

> 8.

> 13. NINDS cerebral palsy information page. National Institute of

> Neurological Disorders and Stroke

> (NINDS). Bethesda, MD: NINDS, National Institutes of Health (NIH).

> Last update: January 25,

> 2006. Accessed March 26, 2007. Available at URL address:

>

http://www.ninds.nih.gov/disorders/cerebral_palsy/detail_cerebral_pals

> y.htm

> 14. NOMC [North Oakland Medical Centers] Euro-Pçds program: SUIT

> therapy. 2004. Accessed

> March 26, 2007. Available at URL address:

> http://www.europeds.org/epp_st.htm

> 15. Rosenbaum P. Cerebral palsy: what parents and doctors want to

> know. BMJ. 2003

> May 3;326(7396):970-4.

> 16. Rudolph CD, Rudolph AM, Hostetter MK, Lister GE, Siegel NJ,

> editors. Rudolph's pediatrics. 21st

> ed. New York, NY: McGraw-Hill; 2003. Ch. 25.

> 17. Suit therapy for cerebral palsy [information about the TheraSuit

> Method™ and the TheraSuit™].

> Therasuit LLC. Accessed March 26, 2007. Available at URL address:

> http://www.suittherapy.com/

> 18. United Cerebral Palsy (UCP). The Adeli Suit [research fact

sheet:

> diagnosis/treatment].

> Washington, DC: United Cerebral Palsy (UCP) Research & Educational

> Foundation; 1999 Mar.

> Page 6 of 6

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> Accessed March 26, 2007. Available at URL address:

> http://www.ucp.org/ucp_generaldoc.cfm/1/4/24/24-6608/82

> 19. United Cerebral Palsy (UCP). The Adeli Suit Update [research

fact

> sheet]. Washington, DC:

> United Cerebral Palsy (UCP) Research & Educational Foundation; 2004

> Nov. Accessed March

> 26, 2007. Available at URL address:

> http://www.ucp.org/ucp_generaldoc.cfm/1/4/24/24-24/5896

> 20. United Cerebral Palsy (UCP). The Treatment of Cerebral Palsy

> [research status report].

> Washington, DC: United Cerebral Palsy (UCP) Research & Educational

> Foundation; 2003 Jun.

>

http://www.cigna.com/.../coverage_positions/medical/mm_0353_coveragepo

> sitioncriteria_suit_therapy.pdf

>

> =====

>

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