Mode
Text Size
Log in / Sign up
N/A N=6 Single-blind Treatment

Gait in Children With Down Syndrome While Wearing Orthoses

Down Syndrome

Enrolled (actual)
6
Serious AEs
Results posted
Dec 2013
Primary outcome: Primary: Step Width — 10.4 cm

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Supramalleolar Orthoses (Cascade) (Device)
Age
Pediatric · 2+ yrs
Sex
All
Sponsor
University of Puget Sound
Primary completion
Jun 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Step Width
10.4

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • Participants must be able to walk independently or with an assistive device, for 50 feet at one time, and have at least six months of walking experience. Participants must also be able to follow simple verbal instructions.

Exclusion Criteria

  • Exclusion criteria include a history of uncorrected visual and inner ear impairments, and lower extremity orthopedic surgical corrections.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01598350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search