An Examination of the Evidence to Support Or Refute the Use of Foot Orthotics in Children

A Review of the Literature to Examine the Use of Foot Orthotics in Children with Down Syndrome.

PREPARED BY: Joan Glover, BSC PT, physiotherapist, Queen Alexandra Centre for Children’s Health Lynn Purves, BSR, physiotherapist, Queen Alexandra Centre for Children’s Health

DATE: May 22,2008

CLINICAL SCENARIO: Physiotherapists from QACCH usually follow children with Down syndrome, in the Victoria area during their infant and preschool years. We are seeking information regarding the efficacy of orthotic management of children with Down syndrome.

All children with Down syndrome have some degree of gross motor delay which may be related to varying degrees of low muscle tone, muscle weakness, joint hypermobility, poor postural stability with delayed postural responses, cognitive impairment, sensory impairments and often additional medical problems. (1,2)

Generally the posture and gait of a child with Down syndrome differs from that of a typical child. They tend to have a wider base of support, out-toeing, smaller step length, increased flexion at hips and knees during stance (1,2)

Persons with Down syndrome have an increased incidence of many orthopaedic concerns including: o Metatarsus primus varus and/or hallux varus with possible shoe fitting difficulties o Pes planovalgus, (19%) which may become painful and rigid during the third decade o Scoliosis (7 to 15%) o Patellar instability, genu valgum (10 to 20%) o Hip problems; instability or dislocation, slipped capital femoral epiphysis, Legg-Perthe’s disease (1to 5%) o Atlanto-axial and cervical spine instability (1.7 to 30%-symptomatic 1-2%) o Foot pain that may limit function in later life o Arthroplasty of Down syndrome (1.2%) o Arthritis - As the life expectancy of persons with Down syndrome is increasing, so is the incidence of painful arthritis, which has been found to limit ambulation in adulthood. (1,3,4)

Merrick et al, in a survey of 475 individuals with Down syndrome in Israel found statistical significance between generalized joint laxity and knee problems, pes planus as well as other medical conditions in persons with Down syndrome. (3)

Concolini performed complete podiatric exams on 50 children with Down syndrome, without major orthopaedic difficulties, aged 4 to 10 years and 100 typical children, aged 3 to 8, and compared the incidence of minor orthopaedic anomalies. He found incidence much higher than is generally reported in the children with Down syndrome: joint laxity in the foot 100% (mild 0% moderate 80%, severe 20%) flat foot 60%, isolated calcaneal valgus 24%, knee valgus 22%, and rigid flat foot 16%. An abnormal biomechanical function of the foot was found in 45% of children with DS. Concolini recommends that postural correction carried out at an early age “can remarkably improve the physical development of the subject.” He suggests that early treatment with orthotics and/or physiotherapy may prevent more serious pathology. (5) Many authors recommend orthotic management of children with mild to moderate flatfoot as well as shoes with appropriate width in the toe box. (4). Ganaze recommends higher orthotics: supramalleolar or ankle foot orthotics during the Down’s syndrome’s child’s progress from cruising to early walking but suggests that later, when muscle tone improves and they are adept at walking they may progress to a UCBL-type foot orthotic. He stresses that they require rigid passive control of pronation in order to prevent the abnormal joint surface remodeling that may follow long-standing malposition (5)

In the Early Intervention Programme physiotherapists are available to assist families in promoting the best possible development of functional movement, postural stability, strength, fitness and participation in recreational activities. Children with Down syndrome frequently have pronated feet and it is often a presenting concern of their parents. It is a common impression among EIP physiotherapists, that stabilizing the pronated foot in a better position may enhance balance, posture and progress in motor development, however, there is a great deal of variability in the management of pronated feet in children with Down syndrome..

Search Strategy Databases (PEDro, Pubmed, Cinahl, Cochrane Library, OTseeker) were searched for all publications with the following key words in the abstract: Down syndrome, children, “foot orthotics”, orthopaedic, physiotherapy. We are planning further work on other aspects of PT management of children with DS and so some publications or their abstracts were filed for future topics. Three EIP physiotherapists reviewed the abstracts of publications retrieved and together decided on whether it appeared that the publication might provide information that could guide our practice. If there was disagreement, we requested the article. The reference lists of articles found were also hand searched for additional relevant references. We have included in our results three clinical trials of orthotics with children with Down syndrome. Clinical information was gleaned from other articles on Down syndrome that were expert opinion or surveys of incidence and this information has been shared with physiotherapists in a presentation on ”Down syndrome: Factors Influencing Motor Development” which is available on our clinical drive or in the clinical scenario of this paper. NHMRC level Basis of Evidence

I Evidence obtained from a systematic review of all relevant randomised controlled trials II Evidence obtained from at least one properly designed randomised controlled trial III - 1 Evidence obtained from well-designed pseudorandomised controlled trials (alternate allocation or some other method) III - 2 Evidence obtained from comparative studies (including systematic reviews of such studies) with concurrent controls and allocation not randomised, cohort studies, case-control studies, or interrupted time series with a control group III - 3 Evidence obtained from comparative studies with historical control, two or more single arm studies, or interrupted time series without a parallel group IV Evidence obtained from case series, either post-test or pretest/ post-test

CLINICAL TRIALS REVIEWED:

Martin K. Effects of supramalleolar orthoses on postural stability in children with Down syndrome. Developmental Medicine and Child Neurology; Jun; 46(6): 406-11. 2004

AIM: To explore the effects of a flexible supramalleolar orthoses on the postural stability of children with Down syndrome

STUDY DESIGN: case series

PARTICIPANTS: 14 Children with Down syndrome; -between 3 1/2 and 8 years of age -can walk 30 yards independently - no history of inner ear impairment, uncorrected visual impairment or seizures, -ability to follow simple commands. The subjects were divided into 2 groups, “more lax” and “less lax”, based on measurements of joint laxity in order to examine whether laxity might influence outcomes

INTERVENTION: Flexible supramalleolar orthoses were provided. Specific fabrication details were included in the reference.

OUTCOME MEASURES:  Gross Motor Function Measure (GMFM) (standing, walking, running, jumping dimensions).  Bruninks-Oseretsky Test of Motor Performance (BOTMP) (balance subtest) Three assessment periods:  First visit-tested with shoes only  2 to 3 weeks later: tested with shoes only then tested with SMOs and shoes  After 6 weeks of wearing SMOs- tested with SMOs and shoes, then tested with shoes only.

MAIN FINDINGS: GMFM: There was a significant difference between the orthotic and shoes only conditions but no significant difference between sessions. BOTMP: The SMOs offered a mean improvement of 0.64 over shoes only at the second session and a larger effect (2.64) by the third session. When the “less lax” and “more lax” groups were compared, the “more lax” group scored lower on all dependent measures but the mean differences between orthotic and non orthotic use were not significantly different

ORIGINAL AUTHORS’ CONCLUSIONS: This study supports the hypothesis that flexible supramalleolar orthoses have a positive impact on postural stability.

CRITICAL APPRAISAL: Low level of evidence (Sackett’s IV) case series No blinding of examiners so potential bias The data from 3 children was eliminated (21%)

SUMMARY: This study provides weak evidence that supramalleolar orthotics may have a positive impact on postural stability in children with Down syndrome .

CLINICAL NOTES OF INTEREST:  Children with more laxity generally performed more poorly on tests of postural stability.  No precedent to grade severity of joint laxity in children with Down syndrome Provides rationale and specific information re the SMOs used in the study (flexible, thinner, shorter footplates, which did not require cast impression.

The effect of foot orthoses on standing foot posture and gait of young children with Down syndrome (2001) Selby-Silverstein L, Hillstrom HJ, Palisano R J, NeuroRehabilitation; 16(3): 183-93. 2001

AIM: To determine if foot orthoses immediately affected the gait of children with Down syndrome and excessively pronated feet STUDY DESIGN: case series

PARTICIPANTS: 16 children with Down syndrome (Trisomy 21 type only) between 3 and 6 years of age who; had been walking for one year or more had excessive foot pronation (calcaneal stance angle greater than 7ºminus the child’s age) had hindfeet flexible enough to be positioned in neutral had not worn foot orthotics for 3 months INTERVENTION: provided custom foot orthotics. Specific information was provided regarding fabrication, fitting and adjustment. CONTROL: There was no control group though 10 children without disabilities were assessed using the same tests to provide a normal comparison group OUTCOME MEASURES:  Calcaneal stance position photographed in bare feet and FOs through a plexiglass grid .  Gait analysis and pressure data was collected using using a force plate, motion analysis system, footprint pressure platforms, split screen videography, a tachometer and computer facilities. Reliability and accuracy of data was reported.  Data was reduced by individuals blinded to the subject or trial number. Calcaneal stance angle measured by assistants blind to the hypothesis or subject Subjects were assessed twice; first with shoes only, and one week later in FOs and shoes MAIN FINDINGS:  The mean resting calcaneal stance position was 11ºin barefeet and 3ºin orthotics, a 73%change (p< 0.001)  Mean transverse plane foot angle was 7ºin sneakers and 0ºin sneakers and orthotics (p<0.001)  Less trial-to-trial variability for transverse plane foot angle, pronation-supination index, foot length contact and stance phase walking speed when wearing orthotics.  Greater trial-to-trial variability of peak ankle torque and phase peak torque.  Feet were more supinated with orthotics on.  Stance phase walking speed was 6% slower with orthotics on ORIGINAL AUTHORS’ CONCLUSIONS:  Foot orthotics immediately decreased excessive heel eversion.  With orthotics, transverse plane foot angle became more internally rotated (and significantly more internally rotated that the normal group  Hypothesis that children with Down syndrome under age 7 may have delayed external tibial  Possibly the longer stance phase might be interpreted as improved single leg support  Reduced variability in gait might indicate greater control and consistency of foot movements and walking speed

CRITICAL APPRAISAL: Low level of evidence-Sackett’s IV- case series

SUMMARY: This study provides some preliminary evidence that custom made foot orthotics may promote an improved calcaneal position, less out-toeing, a longer stance phase, and less variability in gait in young children with Down syndrome

CLINICAL NOTES OF INTEREST:  Simple measurement of calcaneal stance angle page 185.  Orthotics frequently required adjustment to ensure correction and fit.  Important to ensure that insole of shoe does not alter foot alignment.  FOs may cause torsional forces up the leg. In children with laxity it could result in knee torsion rather that tibial torsion. Evaluate knee ligament laxity and muscular support around the knee when providing FOs. If necessary this should be augmented with knee supports or knee strengthening  Specific physiotherapy recommendations to consider when providing FOs include: o Strengthening of lower extremities aimed at increasing push off and muscular support at the knee o Heelcord stretching with the heel in neutral alignment if limitation exists o Encourage dynamic balance activities (running or descending stairs) in which weight shifts during late swing rather than waiting for heel contact.

Dynamic Foot Orthotics and Motor Skills of Delayed Children. (Pitetti KH, Wondra VC, Journal of Prosthetics and Orthotics, Volume 17, number1, 2005

AIM: To determine the effect of a minimum dynamic foot orthoses on the locomotor skills of children with gross motor delays.

STUDY DESIGN: case series

PARTICIPANTS: 25 children, below 60 months of age with the diagnosis of a gross motor delay and: -a z score of _1.33 or lower on the locomotor scales Peabody Developmental Motor Scales, 2nd edition (PDMS-2) -enrolled in early intervention program that includes physiotherapy at least weekly -medically stable (no uncontrolled seizures, progressive neurological diseases, FAS. Acquired immunodeficiency syndrome or blindness) Two of the selected children had Down syndrome and 3 had cerebral palsy Eight children were lost to follow up due to summer recess (32%)

INTERVENTION: Minimum controlled dynamic foot orthoses (Cascade Pattibobs) were provided. Procedure was specifically described

OUTCOME MEASURES: Locomotor scales of PDMS-2 were administered 4 times:  initially with shoes only  one week later in DFOs , after wearing DFOs for 1 week  After 2 months of wearing DFOs subject were tested both with and without DFOs. The order of testing was determined randomly

Reliability, validity, interrater reliability and test-retest reliability were reported

RESULTS: Significantly higher scores on the Peabody locomotor scale were seen with inserts compared to without inserts. Scores were significantly higher following two months with orthotics compared to assessment at 2 months without orthotics and also when compared to initial assessment with and without DFOs AUTHORS’ CONCLUSIONS: This study suggests that DFOs improved locomotor capacities of children with gross motor delays

Although the authors had not intended to compare improvements among disability categories, they were able to separate out the results of the 2 children with Down syndrome and 3 children with cerebral palsy. In these cases they found small but not significant improvement after 2 months with DFOs. They hypothesize that the DFOs may not provide high enough support for the amount of joint instability and motor control problems in children with Down syndrome and cerebral palsy. They acknowledge that the small number of participants with these conditions prevents any definite conclusion and suggest more research in Down syndrome and cerebral palsy COMMENTS RE STUDY DESIGN Sackett’s level of evidence IV- considered weak evidence Physiotherapists conducting the assessment were not blind to whether or not the child was wearing orthotics, so there is potential for bias

Eight children were lost to follow up due to summer recess (32%) CONCLUSION: Although this study provides some weak preliminary evidence that minimal control DFOs may improve locomotor function in children with gross motor delay, there is not sufficient evidence to conclude whether flexible minimum control dynamic foot orthoses can effect the locomotor skills of children with Down syndrome.

CLINICAL NOTES OF INTEREST: The authors suggest that possibly DFOs may not provide high enough support to provide joint stability and improve motor control in children with Down syndrome or cerebral palsy, though their numbers were too small to draw conclusions.

Initial assessments were done on 8 children with motor delays (z scores were above -1.33, who were eliminated from the study, as they did not meet the criteria for inclusion. These children did not show significant improvements with orthotics in the first assessments. The authors suggest there may be a threshold for the degree of motor impairment that might respond to DFOs

It was interesting to note no mention of pronation or foot posture in this study

OVERALL CONCLUSIONS: Three clinical trials of use of orthotics for children with Down syndrome were found. These were reviewed by at least 2 physiotherapists using the Guideline for Critical Review-Quantitative Studies developed by Law et al. (6). Two of the three studies offer some preliminary evidence (all Sackett’s level of evidence IV) that foot orthotics or supramalleolar orthotics may improve gait and/or balance. The types of bracing used (dynamic foot orthotics, supramalleolar orthotics and foot orthotics) varied between studies as did the outcomes measured (posture and gait analysis, balance, or loco motor progress) and so no conclusions can be drawn about the best orthotics management. Further studies are required. These studies do suggest that orthotics should be considered as a component of the management of motor development of children with Down syndrome with pronated feet, and the effect on balance, alignment and motor function assessed individually.

REFERENCES: 1. Shea Alice, Motor Attainments in Down Syndrome, in Contemporary management of Motor Control Problems, Proceedings of the II STEP Conference, ed Lister M 1991

2. Lauteslager P, Vermmer A, Helders P, Disturbances in the Motor Behaviour of Children with Down Syndrome: The need for a theoretical framework, Physiotherapy, January 1998, vol 84, no1. 3. Merrick J, Ezra E, Josef B, , Hendel D, Steinberg D, Wientroub S, Musculoskeletal Problems in Down Syndrome European Paediatric Orthopaedic Society Survey: The Israeli Sample. Journal of Paediatric Orthopaedics Part B, (: 185-192, 2000

4. Caird NS, Wills MD, Dormans J, Down Syndrome in Children: The Role of the Orthopaedic Surgeon, Journal of the American Academy of Orthopaedic Surgeons, Volume 14, Number 11, October 2006

5. Concolino D, Pasquzzi G, Capalpbo G, Sinopoli S,, Strsciuglio P, Early detection of podiatric anomalies in children with Down Syndrome, Acta Paediatrica,:95: 17-20,2006

6. Genaze Robert, Pronation, The Orthotist’s View, Clinical podiatric Medicine and Surgery 17:481-503, 200

7. Law M, Stewart D, Pollicj N, Letts L, Bosch J, Westmorland M, (1998) Critical Review Form-Quantitative Studies (McMaster University). Accessed on www May 2000

8. Martin K. Effects of supramalleolar orthoses on postural stability in children with Down syndrome. Dev Med Child Neurol. Jun; 46(6):406-11. 2004

9. Selby-Silverstein L, Hillstrom HJ, Palisano RJ. The effect of foot orthoses on standing foot posture and gait of young children with Down syndrome. NeuroRehabilitation; 16(3): 183-93. 2001

10. Pitetti K, Wondra V, Dynamic Foot Orthosis and Motor Skills of Delayed Children, Journal of Prosthetics and Orthotics, Vol17, Number1, 2005