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

Down Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390558
• Other study ID #: Gait Parameters Down Syndrome
• Status: Completed
• Start date: June 2011
• Est. completion date: August 27, 2018

Study information

• Verified date: February 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 27, 2018
• Est. primary completion date: August 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 80 Years

Eligibility

Inclusion Criteria:

• Down Syndrome, independent walkers

Exclusion Criteria:

• Down Syndrome, not independently walking

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Child Development and Rehabilitation Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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