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:
Oregon Health and Science University
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01390558
First received: June 27, 2011
Last updated: July 8, 2011
Last verified: June 2011
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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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 2014 (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| Ages Eligible for Study: | 2 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| 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 |
| Study First Received: | June 27, 2011 |
| Last Updated: | July 8, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Oregon Health and Science University:
|
Down Syndrome Orthotics Gait Analysis |
Additional relevant MeSH terms:
|
Down Syndrome Mental Retardation Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |
Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 21, 2013