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

This study is currently recruiting participants.
Verified June 2011 by Oregon Health and Science University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01390558
First Posted: July 11, 2011
Last Update Posted: November 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by:
Oregon Health and Science University
  Purpose
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.

Condition Intervention
Down Syndrome Procedure: custom orthotics

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Gait Parameters of Persons With Down Syndrome With and Without Orthotics Using GaitRite

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: June 2011
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Persons with Down Syndrome followed in Down Syndrome clinic Persons with Down Syndrome recruited in the community
Criteria

Inclusion Criteria:

  • Down Syndrome, independent walkers

Exclusion Criteria:

  • Down Syndrome, not independently walking
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390558


Contacts
Contact: Kerry Michaelis, DPT 503-494-7864 michaeli@ohsu.edu
Contact: David L Oleson, BSPT 503-494--2718 olesond@ohsu.edu

Locations
United States, Oregon
Child Development and Rehabilitation Center Recruiting
Portland, Oregon, United States, 97239
Contact: Kerry Michaelis, DPT    503-494-7864    michaeli@ohsu.edu   
Contact: David L Oleson, BSPT    503-494-2718    olesnd@ohsu.edu   
Principal Investigator: Michaelis Kerry, DPT         
Sub-Investigator: Oleson L David, BSPT         
Sponsors and Collaborators
Oregon Health and Science University
  More Information

Responsible Party: David Oleson, PT, PCS, Child Development and Rehabilitation Center, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01390558     History of Changes
Other Study ID Numbers: Gait Parameters Down Syndrome
First Submitted: June 27, 2011
First Posted: July 11, 2011
Last Update Posted: November 7, 2014
Last Verified: June 2011

Keywords provided by Oregon Health and Science University:
Down Syndrome
Orthotics
Gait Analysis

Additional relevant MeSH terms:
Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn


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