Clinical Trial: Gait in Children With Down Syndrome While Wearing Orthoses

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Using Anthropometric Measurements to Predict Orthotic Influence on Gait Parameters in Children With Down Syndrome

Brief 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 indication

Detailed Summary:

The purpose of this study is to demonstrate the differences in functional outcomes provided by supramalleolar orthoses and foot orthoses, as well as develop specific criterion for matching individuals with Down syndrome (DS) of differing orthopedic impairments with the most beneficial orthotic device.

Participants must be able to walk independently or with an assistive device, such as a walker, 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. Both males and females will be included in this study, and children of any race may participate as long as they meet the inclusion criteria and are between three and ten years of age at the time of data collection. Exclusion criteria include a history of uncorrected visual and inner ear impairments, and lower extremity orthopedic surgical corrections.

There are no costs associated with participation in this study, and subjects will not be paid for their participation.

Participants in this study will be fitted for the appropriate size orthoses either by physical therapists in the participants' school district, or by one of the researchers prior to data collection. The correct fitting orthotic will be sized using the sizing guides provided by Cascade. These are footplates of various sizes that provide the length of the child's foot in inches and the orthosis width that will fit the child. Measurements of height, weight, leg length, medial longitudinal arch height, tibial torsion, and calcaneal eversion will be taken for each subject. Weight will be measured in kilograms using a scale, while height, leg length, and medial longitudinal arch height will be measured using a metric tape measure. Tibial torsion will be measured with the participant
Sponsor: University of Puget Sound

Current Primary Outcome: Step Width [ Time Frame: 60 minutes ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Puget Sound

Dates:
Date Received: January 20, 2010
Date Started: January 2010
Date Completion:
Last Updated: November 12, 2013
Last Verified: November 2013