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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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02046889
The ClinicalTrials.gov registry entry for NCT02046889 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (15% higher). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 2 distinct geographic areas - top geographies include 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.
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