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

NCT01390558 | Completed DMC

• 1 other identifier: Gait Parameters Down Syndrome
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Down Syndrome

Keywords

Down Syndrome; Orthotics; Gait Analysis

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 years

Secondary Outcomes (1)

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

  3 years

Study Arms (2)

Persons with Down Syndrome who use orthotics

Orthotic users

Procedure: custom orthotics

Persons with Down Syndrome who do not use orthotics

Non orthotic users

Interventions

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.

Persons with Down Syndrome who use orthotics

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons with Down Syndrome followed in Down Syndrome clinic Persons with Down Syndrome recruited in the community

You may qualify if:

• Down Syndrome, independent walkers

You may not qualify if:

• Down Syndrome, not independently walking

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Child Development and Rehabilitation Center

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: July 11, 2011
• Study Start: June 1, 2011
• Primary Completion: August 27, 2018
• Study Completion: August 27, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

US (1)