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TheraSuits and Other Fancy Stuff: Orthotic and

Therapeutic Considerations

7th Annual Developmental Disabilities Conference

March 7, 2008

Amy Houtrow, MD, MPHPediatric PM&RUCSF Pediatrics

Disclosures

Nothing to disclose

No relationship with any of the programs or devices discussed

Presentation Objectives

To review the epidemiology and rehabilitation issues for children with cerebral palsy

To gain knowledge about various therapeutic techniques and devices

To review of the evidence to support these techniques and devices

To gain comfort with addressing parental concerns questions

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What is Cerebral Palsy? Consensus Definition

“CEREBRAL PALSY describes a group of disorders of the development of movement and posture, causing activity limitation, that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain. The motor disorders of cerebral palsy are often accompanied by disturbances of sensation, cognition, communication, perception, and/or behavior, and/or by a seizure disorder.” International Workshop on Definition and Classification of Cerebral Palsy, 2004

Cardinal Features of CPNeuromotor control problem that affects movement and posture

Non-progressive (static encephalopathy)Symptoms change over time

Injury or anomaly is present early

There is no cure

Epidemiology of CP

Most common cause of significantchildhood disability

2-2.5 per 1,000live births

~8,000 new diagnoses in the US each year

PrognosticationThe question all parents ask: Will my child walk? Most of the time the answer is yes.

Spastic hemiplegia - most walk at 12-18 months, nearly all by 3 yearsSpastic diplegia - 80-90% walk in some fashion, usually by 4 yearsSpastic quadriparesis - 10-50% walk, 25% are dependent for all activities

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The Pediatric PM&R Physician’s Role

Confirms and clarifies the diagnosisAddresses therapy needs, mobility, function and equipmentHelps direct care to appropriate providers Advocates for the child

Helps child and family actualize potential and minimize negative symptoms

Addressing therapy and equipment needs to improve function

Typical therapies: PT, OT, SLPAdaptive equipment: bracing, mobility aides (wheelchairs, walkers…), communication devices, ADL equipment

Does therapy work?Yes –shown in multiple studies

Does more therapy work better?Sometimes but the issue is long term carry-over

Bower 1996, Bower 2001, Damiano 2002, Dodd 2002, Blundell 2003

But What About????The Therasuit/Adeli SuitTheratogsHyperbaric Oxygen TherapyHippotherapyConductive EducationPatterning Craniosacral therapy

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The TheraSuit

“Its major goal is to improve and change proprioception (pressure from the joints, ligaments, muscles), reduce patient's pathological reflexes, restore physiological muscle synergies (proper patterns of movement) and load the entire body with weight”.http://www.suittherapy.com/

Benefits as Touted by TheraSuit Re-trains central nervous systemRestores ontogenic developmentProvides external stabilizationNormalizes muscle toneAligns the body to as close to normal as possibleProvides dynamic correctionNormalizes (corrects) gait patternProvides tactile stimulationInfluences the vestibular systemImproves balanceImproves coordinationDecreases uncontrolled movements in ataxia and athetosis

Improves body and spatial awarenessSupports weak musclesProvides resistance to strong muscles to further enhance strengtheningImproves speech production and its fluency through head control and trunk supportPromotes development of both fine and gross motor skillsImproves bone densityHelps to decrease contracturesHelps improve hip alignment through vertical loading over the hip joint

The TheraSuit Method

“This intense program is ideal for those who want to enhance & improve the child's developmental & functional abilities (ex: mobility, balance & coordination, gait, etc.).”3-week session with the child being seen 5 days per week for 3 hours per day Cost per week is $1,650.00

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Adeli Suit

The precursor of the TheraSuitDeveloped in Russia in the 1971The Adeli Suit consists of a vest, shorts, knee pads and specially adapted shoes with hooks and elastic cords that help tell the body how it is supposed to move in space. Therapists use the Adeli Suit to hold the body in proper physical alignment. During specialized exercises, the therapists adjust the elastic connectors that topographically mirror flexor and extensor muscles, trunk rotators and the lower limbs.

Evidence for the Adeli Suit/ TheraSuitNumerous testimonials and case reports (mostly unpublished)

Comparison of Suit therapy versus neurodevelopmental treatments failed to show differences between the therapy types, both groups showed small but significant improvements in efficiency index of stair climbing (Bar-Haim 2006)

Dr. Edward Dabrowski at the Children's Hospital of Michigan reported the results of 57 children, all of whom received an hour of physical, occupational, and speech therapy three times a week for 8-10 weeks followed by a 4-week home program. The experimental group wore the Adeli Suit for the last 4 weeks of their therapy program. Both groups improved and sustained their improvement without any statistical difference in results between the 2 groups.(UCP Research and Education Fund April 2004)

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TheraTogs

“TheraTogs are comfortable, breathable garments that support and reinforce what an occupational or physical therapist’s hands do to help the physically impaired correct postural or biomechanical problems.” http://www.theratogs.com/

TheraTogs

Theory and Evidence for TheraTogs

Theory: the material allows for mechanical forces to be applied to the patient without the use of the therapist handsEvidence: testimonials, case reports (unpublished) Cost: about $1000 for a full suit, insurance sometimes covers costs

Hyperbaric OxygenDelivery of 100% oxygen under pressure (1.5-1.75 x atmospheric pressure) in a chamber in which the child and parent or therapist does activitiesUsually treatments are 1-2 hrs per day 5 days a week for a monthPotential side effects include: ear pain, eardrum perforation, pneumothorax Cost: $400 per 90 minute session (McDonagh 2007)

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What does HBOT do?Touted to improve oxygen delivery to the dormant cells around the damaged cells that may then be stimulated to function normallyBased on the ischemic penumbra theory

Manytestimonials

HBOT - Evidence Collet et al Lancet 2001

Design: multi-center, double blind, placebo controlledSubjects: 111 children, 3-12 yrs. with spastic CPIntervention:

40 - 60 minute sessions of 100% O2 at 1.75 ATA or RA at 1.3 ATA Conventional therapies and spasticity medications held 6 weeks prior

Standardized outcome measuresBaseline, 20th session, 40th session, and 3 months later

Results:Significant improvement in gross motor skills, working memory, attention, language and self-care skills in bothgroups

Evidence for HBOTSystematic review in Developmental Medicine and Child Neurology found insufficient evidence to support the use of HBOT, several studies show similar improvements when HBOT is compared with pressurized air (McDonagh 2007)

Review by Liptak points out the potential effects of highly motivated parents (Liptak 2005)

Side effects are sometimes severe

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Hippotherapy

Theory: horseback riding improves head and trunk control, mobility, pelvic stability and improves range of motionRisk: fall from horse

Evidence for Hippotherapy

Review in Developmental Medicine and Child Neurology 2007 (Sterba 2007)

11 quantitative studies with acceptable design evaluated hippotherapy or recreational horseback riding (not performed by a licensed PT/OT)10 of 11 showed improvements in gross motor function

Conductive Education (Darrah 2004)

First developed in the 1940s by Dr. Andreas Peto in HungaryA model that blends therapy techniques in an educational modelCarried out by trained ‘conductors’ in group settingsStructured activities are broken down by tasks into series of steps of intentional activities versus isolated exercises

Rhythmic intention: uses song and rhyme coupled with a motor activity to facilitate learning

Example Study forConductive Education

Blank et al studied typical special education and 2 hours of PT/OT per week versus 12 weeks of conductive education for 7 hours a day, 5 days a week with an outcome measure of coordinated hand function

CE improved coordinated hand function by 20-25%, while the typical program did not (Blank 2008)

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Evidence for Conductive EducationPlethora of research ranging from descriptive studies to controlled trials

Of the 20 studies that showed statistically significant difference between therapeutic types, 10 showed improvement with Conductive Education and 10 showed improvements with standard therapies (Darrah 2004)

PatterningDeveloped by Fay, Delacato and Doman in the 1950-60s. Principle that typical development progresses through a sequence that if impaired inhibits the development of the subsequent stagesHypothesis: passively repeating the sequential steps will facilitate developmental skills

Evidence for Patterning

Many studies ongoing to evaluate this technique for spinal cord injury recovery

For children with cerebral palsyAAP does not support recommending patterning therapy (AAP 1999)

AACPDM, AAPM&R and AAN do not recommend patterning

Found to be time intensive without significant added benefit and costly

Craniosacral TherapyTheory that a cranial rhythm exists which is linked with movements in the sacrum through mechanical forces transmitted through the dura of the spinal cordGoal of therapy is to allow unimpeded flow of CSFLight pressure is applied to points along the cranial-sacral axis to restore symmetric impulses

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CranioSacral TherapyOriginated by William Sutherland, DO in 1930’sPrimary proponent currently is John Upledger, DOUsed widely for a vast array of disorders and complaints

Evidence for Craniosacral Therapy

Blinded study show that craniosacral therapists cannot identify the same impulses/channels on the same individual (Norton 1996)

No scientific evidence to support cranio-sacral therapyAvailable literature calls into question the foundation of the technique (Liptak 2005)

Talking to Families

Take into account the goals and expectations of the family

Frame goals in a realistic wayTalk about efficacy and risksEncourage critical evaluation of programs and techniquesEncourage programs with known benefits

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Counseling FamiliesCommittee on Children with Disabilities Pediatrics 2001

Be respectfulProvide enough time for the discussionInvestigate sources of informationHelp families understand scientific rigor, placebo effectListen carefully and acknowledge the family’s concerns

Be supportiveRemain involved even if you disagreeAvoid becoming defensiveIf controversial therapies are employed, encourage clear objectives and evaluations

REFERENCESBar-Haim, S., N. Harries, et al. (2006). "Comparison of efficacy of Adeli suit and neurodevelopmental treatments in children with cerebral palsy." Dev Med Child Neurol 48(5): 325-30.Bax, M., M. Goldstein, et al. (2005). "Proposed definition and classification of cerebral palsy, April 2005." Dev Med Child Neurol 47(8): 571-6.Blank, R., R. von Kries, et al. (2008). "Conductive education for children with cerebral palsy: effects on hand motor functions relevant to activities of daily living." Arch Phys Med Rehabil 89(2): 251-9.Blundell, S. W., R. B. Shepherd, et al. (2003). "Functional strength training in cerebral palsy: a pilot study of a group circuit training class for children aged 4-8 years." Clin Rehabil 17(1): 48-57.Bower, E. and D. L. McLellan (1994). "Evaluating therapy in cerebral palsy." Child Care Health Dev 20(6): 409-19.Bower, E., D. L. McLellan, et al. (1996). "A randomised controlled trial of different intensities of physiotherapy and different goal-setting procedures in 44 children with cerebral palsy." Dev Med Child Neurol 38(3): 226-37.

REFERENCESDamiano, D. L., K. Dodd, et al. (2002). "Should we be testing and training muscle strength in cerebral palsy?" Dev Med Child Neurol 44(1): 68-72.Darrah, J., B. Watkins, et al. (2004). "Conductive education intervention for children with cerebral palsy: an AACPDM evidence report." Dev Med Child Neurol46(3): 187-203.Dodd, K. J., N. F. Taylor, et al. (2002). "A systematic review of the effectiveness of strength-training programs for people with cerebral palsy." Arch Phys Med Rehabil83(8): 1157-64.Goldstein, M. (2004). "The treatment of cerebral palsy: What we know, what we don't know." J Pediatr 145(2 Suppl): S42-6.Liptak, G. S. (2005). "Complementary and alternative therapies for cerebral palsy." Ment Retard Dev Disabil Res Rev 11(2): 156-63.

REFERENCESMcDonagh, M. S., D. Morgan, et al. (2007). "Systematic review of hyperbaric oxygen therapy for cerebral palsy: the state of the evidence." Dev Med Child Neurol 49(12): 942-7.Mutch, L., E. Alberman, et al. (1992). "Cerebral palsy epidemiology: where are we now and where are we going?" Dev Med Child Neurol 34(6): 547-51.Odman, P. and B. Oberg (2005). "Effectiveness of intensive training for children with cerebral palsy--a comparison between child and youth rehabilitation and conductive education." J Rehabil Med 37(4): 263-70.Odman, P. E. and B. E. Oberg (2006). "Effectiveness and expectations of intensive training: a comparison between child and youth rehabilitation and conductive education." Disabil Rehabil 28(9): 561-70.Sterba, J. A. (2007). "Does horseback riding therapy or therapist-directed hippotherapy rehabilitate children with cerebral palsy?" Dev Med Child Neurol49(1): 68-73.Ziring, P. R., D. brazdziunas, et al. (1999). "American Academy of Pediatrics. Committee on Children with Disabilities. The treatment of neurologically impaired children using patterning." Pediatrics 104(5 Pt 1): 1149-51.