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
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 27, 2011 | ||||||||
| Last Updated Date | July 8, 2011 | ||||||||
| Start Date ICMJE | June 2011 | ||||||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01390558 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Gait Parameters of Persons With Down Syndrome With and Without Orthotics Using GaitRite | ||||||||
| Official Title ICMJE | Gait Parameters of Persons With Down Syndrome With and Without Orthotics Using GaitRite | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Persons with Down Syndrome followed in Down Syndrome clinic Persons with Down Syndrome recruited in the community |
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| Condition ICMJE | Down Syndrome | ||||||||
| Intervention ICMJE | 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. |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||
| Estimated Completion Date | June 2020 | ||||||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 2 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01390558 | ||||||||
| Other Study ID Numbers ICMJE | Gait Parameters Down Syndrome | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | David Oleson, PT, PCS, Child Development and Rehabilitation Center, Oregon Health and Science University | ||||||||
| Study Sponsor ICMJE | Oregon Health and Science University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Oregon Health and Science University | ||||||||
| Verification Date | June 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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