Down SyndromeNCT01390558
Gait Parameters of Persons With Down Syndrome With and Without Orthotics Using GaitRite
An observational study of Down Syndrome, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 80 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- custom orthotics
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to 27 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Persons with Down Syndrome followed in Down Syndrome clinic Persons with Down Syndrome recruited in the community
Who may be able to join
- Down Syndrome, independent walkers
Who cannot join
- Down Syndrome, not independently walking
Trial locations and contacts
1 site in 1 country.
United States1 site
Child Development and Rehabilitation Center
Portland, Oregon, 97239
About this study
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.
- Conditions
- Down Syndrome
- Being tested
- custom orthotics
- Keywords
- Down Syndrome, Orthotics, Gait Analysis
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
custom orthoticsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Persons with Down Syndrome who use orthotics | Orthotic users Receives: Procedure: custom orthotics | |
| Persons with Down Syndrome who do not use orthotics | Non orthotic users |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJun 2011
- Primary completion27 Aug 2018
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Oleson, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390558
- Sponsor's protocol ID
- Gait Parameters Down Syndrome
- Status last verified
- Feb 2019
- First submitted
- 27 Jun 2011
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Parameters of Persons With Down Syndrome With and Without Orthotics Using GaitRite
- ClinicalTrials.gov ID
- NCT01390558
- Acronym / sponsor ID
- Gait Parameters Down Syndrome
- Conditions
- Down Syndrome
- Keywords
- Down Syndrome, Orthotics, Gait Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persons with Down Syndrome who use orthotics | – | Procedure: custom orthoticsOrthotic users |
| Persons with Down Syndrome who do not use orthotics | – | –Non orthotic users |
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Persons with Down Syndrome followed in Down Syndrome clinic Persons with Down Syndrome recruited in the community
Key inclusion criteria (1 listed)
- Down Syndrome, independent walkers
Key exclusion criteria (1 listed)
- Down Syndrome, not independently walking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| custom orthoticsOrthotics 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. | Procedure or surgery | Persons with Down Syndrome who use orthotics |
Primary outcome
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.
1 secondary outcome
Elucidate patterns in the development of walking in persons with Down Syndrome using GaitRite®.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait will be measured with the GaitRite gait evaluation system. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.