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Your journey
1What's a trial
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More info
You can access this
clinical trial
if you have
Down Syndrome
and you are
between 2 and 10
years old
The phase for this study is not defined.
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The purpose

On average, Down syndrome (DS) occurs once in every 700 live births and results in life-long disability and increased risk for comorbidities.1 Individuals with DS are also susceptible to secondary physical impairments and limitations as a result of complications associated with joint hypermobility, hypotonicity, and increased ligamentous laxity. Secondary impairments such as pes planus (flat feet), weakened muscles, bony abnormalities and arthritis may lead to painful joints and feet. Additionally, children with DS often manifest deviations in gait as a result of physical limitations imposed by orthopedic and muscular deficiencies that may lead to decreased postural stability. These secondary losses in function, which exacerbate disabilities, may be preventable with the use of appropriate early interventions aimed at correcting abnormal joint alignment. Research exploring effective physical therapy interventions for adults and children with DS is currently very limited. However, the use of orthotic devices to support lax ligaments and hypotonic muscles, which are common manifestations of DS, is one accepted method of intervention for children within this population. Orthoses are variable in structure and the degree of support provided to the foot and ankle also differ between foot orthoses (FOs) and supramalleolar orthoses (SMOs). Previous studies have supported the effectiveness of orthoses on improving ankle and foot alignment, as well as gait parameters. However, disagreement currently exists concerning which type of orthotic device is most beneficial for the population of children with DS. Children with DS express variable degrees of joint laxity and hypotonicity, as well as differences in the severity of specific alignment abnormalities such as excessive pronation or calcaneal eversion.6 Current literature is insufficient for explaining differences in the benefits provided by FOs and SMOs and the specific indications for their use in children with DS is unclear. Study Aims This study will demonstrate the differences in structural outcomes provided by FOs and SMOs and develop specific criterion for matching individuals of differing orthopedic impairments with the most beneficial orthotic device.

Provided treatments

  • Device: Supramalleolar Orthoses (Cascade)

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01598350. The sponsor of the trial is University of Puget Sound and it is looking for 6 volunteers for the current phase.
Official trial title:
Using Anthropometric Measurements to Predict Orthotic Influence on Gait Parameters in Children With Down Syndrome