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NCT02046889 · ClinicalTrials.gov registry record · NA
A Bicycle Training Intervention
A NA study of Autism Spectrum Disorder and Down Syndrome, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 155
- Enrollment target
- 3
- Study locations
NCT02046889: Completed NA study of Autism Spectrum Disorder and Down Syndrome, sponsored by University of Michigan.
NCT02046889 is a NA study of Autism Spectrum Disorder and Down Syndrome that has completed, run by University of Michigan. The registered enrollment target is 155 participants, above the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (15% higher). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02046889, a NA study of Autism Spectrum Disorder and Down Syndrome, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 155 participants
- Enrollment target
- 3
- Study locations
Study Summary
The objectives of this study are to 1) demonstrate the effectiveness of the innovative bicycle training program in teaching youth with DS and ASD how to ride a standard two wheel bike, and 2) determine the effects of the treatment on health related performance measures, physical activity level, patterns of sleep behavior, psychosocial outcomes, and community participation. The hypotheses to be tested in this study are: 1) there will be a significant treatment group difference (EXP vs CON) in the number of participants who demonstrate the ability to ride a two wheel bicycle in favor of the EXP group following the first year of training. 2) At the end of the second year of training when the CON group receives the bicycle training program, there will not be a group difference in the number of riders who learned to ride. 3) At the end of the first year, there will be a significant treatment group difference (EXP vs CON) on the health related performance measures, average time spent in moderate and moderate to vigorous physical activity, patterns of sleep behavior (sleep onset, frequency of night waking), self and parent perceptions of bicycle riding ability, and community participation (number of community activities engaged in, frequency of community participation, number of people they participate with outside of the parents, the number of community locations in which they participate), in favor of the EXP group. 4) At the end of the second and third year, the CON group will demonstrate a significant improvement in all of these measures (a significant improvement from the pre-training measures to the 12 and 24 month measures). 5) At the end of the third year, the EXP group will demonstrate a significant group difference on all measures compared to the CON group but the magnitude of the difference will be less than was observed in hypothesis 3 at the 12 month measurement before the CON group received their training. These hypotheses will be tested separately for the DS
Primary Outcome
Participants will be assessed on their ability to independently ride a two-wheeled bicycle at least 100 feet at the conclusion of the 5 day/75 minutes per day intervention.
Conditions Studied
Interventions
- BEHAVIORAL Bicycle Training Intervention
Study Locations (3)
Michigan
- - Ann Arbor
- - Grand Rapids
Indiana
- - Southbend
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2010-06 |
| Est. Completion | 2012-12 |
| Phase | NA |
What the finished NCT02046889 record still lists
NCT02046889 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, above the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (15% higher).
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which Bicycle Training Intervention is the first listed.
NCT02046889 reports a single indexed study location in Michigan, Indiana.
Frequently Asked Questions
What is clinical trial NCT02046889 about?
NCT02046889 is a clinical study titled "A Bicycle Training Intervention". The objectives of this study are to 1) demonstrate the effectiveness of the innovative bicycle training program in teaching youth with DS and ASD how to ride a standard two wheel bike, and 2) determine the effects of the treatment on health related performance measures, physical activity level, patt...
What is the current status of trial NCT02046889?
This trial is currently completed. It is a NA study. The enrollment target is 155 participants. The study started on 2010-06. Estimated completion is 2012-12.
What conditions does trial NCT02046889 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Down Syndrome.
What interventions are being tested in trial NCT02046889?
The interventions under investigation include: Bicycle Training Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT02046889?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02046889 being conducted?
This trial has 3 study locations across Indiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02046889's enrollment target sits among peer trials
155 52nd of 224 higher than 173 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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