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OpenTrials
Completed

NCT Number: NCT01390558

Gait Parameters of Persons With Down Syndrome With and Without Orthotics Using GaitRite

This is a research study of persons with Down Syndrome between 2 and 80 years old who are independently walking. The purpose of this study is to see what effect orthotics have on how people with Down Syndrome walk.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

2 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Child Development and Rehabilitation Center

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Down Syndrome, independent walkers

Exclusion criteria

  • Down Syndrome, not independently walking

Treatment and study plan

custom orthotics

Procedure

Orthotics are fabricated uniquely for each patient and use molds or casts of their foot as the template. They are fabricated by a licensed orthotist. There is no device or brand name other than custom orthotics.

Primary outcomes

  1. Gait will be measured with the GaitRite gait evaluation system.

    Time frame: 3 years

    Specific temporal and spatial parameters of gait will be measured with the GaitRite gait evaluation system. Subjects will walk with and without their orthotics. Measurement will be by changes in the previously noted gait parameters between the orthotics and non-orthotics groups.

Secondary outcomes

  1. Elucidate patterns in the development of walking in persons with Down Syndrome using GaitRite®.

    Time frame: 3 years

    The previously described parameters of gait as measured by the GaitRite system will be used to establish an overview of the development of gait in persons with Down Syndrome.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jul 11, 2011
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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