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.

Study Overview

• Status: Completed
• Conditions: Down Syndrome
• Intervention / Treatment: Procedure: custom orthotics

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Child Development and Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Down Syndrome, independent walkers

Exclusion Criteria:

• Down Syndrome, not independently walking

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Persons with Down Syndrome who use orthotics; Orthotic users	Procedure: custom orthotics; 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 do not use orthotics; Non orthotic users

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elucidate patterns in the development of walking in persons with Down Syndrome using GaitRite®.	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.	3 years

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): August 27, 2018
• Study Completion (Actual): August 27, 2018

Study Registration Dates

• First Submitted: June 27, 2011
• First Submitted That Met QC Criteria: July 8, 2011
• First Posted (Estimate): July 11, 2011

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Down Syndrome; Gait Analysis; Orthotics
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: Gait Parameters Down Syndrome