Autism Spectrum DisorderNCT02046889
A Bicycle Training Intervention
A study testing Bicycle Training Intervention in people with Autism Spectrum Disorder and Down Syndrome, run by University of Michigan at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder, Down Syndrome
- What is being tested?
- Bicycle Training Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2010to Dec 2012
- Phase
- Interventional
- 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 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with Autism spectrum disorder or Down syndrome
- Aged 9-18 years at entry into study
- Cannot independently ride a two-wheeled bicycle
Who cannot join
- Not meeting the inclusion criteria
- Having a condition which would be a safety risk on a bicycle or performing physical activity, including but not limited to a seizure disorder or mobility issue.
- Weighing more than 250 lbs which is the maximum weight allowance for the equipment used during the intervention.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Ann Arbor, Michigan
Study site
Grand Rapids, Michigan
Study site
Southbend, Indiana
About this study
Official title: The Effects of a Bicycle Training Intervention on Health, Physical Activity, Sleep & Community Participation in Youth With Down Syndrome & Autism Spectrum Disorders
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 and ASD groups.
Read the detailed description
Two-wheel bicycle riding skills are considered a societal norm for children and youth in America as well as a life altering activity (Klein, 2004). Most children learn how to ride a bicycle by the age of 7 years. Children with disabilities often require more time to learn functional motor behavior skills and in order to successfully accomplish these skills, children with disabilities also require specialized instruction. Consequently, many children with disabilities never learn how to ride a two-wheel bicycle. If children with disabilities do learn how to ride a two-wheel bicycle, they tend to learn much later than children without disabilities. In the Down syndrome population, it is estimated that less than 10% ever learn to ride a two wheel bicycle. Learning to ride a two-wheel bicycle allows children to participate in this leisure activity with siblings and peers (Klein, 2004). This is true for children with Down syndrome (DS) and children with Autism Spectrum Disorder (ASD). In our previous research, a specialized adapted bicycle has been successfully used to teach children with Down syndrome how to master this important functional motor skill. In our previous research, we successfully trained 62% of children with DS to ride in 5 days (75 minutes per day for 5 days) and as a result, they displayed significantly less time in sedentary activity and significantly more time in moderate to vigorous activity 12 months following training compared to the control group. Of the 62% of children with DS who learned to ride, 54% were still riding 18-24 months after receiving the training.The children start learning how to ride the two-wheel bicycle on a very stable adapted bicycle (thick roller wheels attached to the rear wheel) and quickly progress towards a standard two-wheel bike. The results of our first bicycle study suggested that the 38% who did not reach mastery of riding a two wheel bike needed more follow up training. In our most recent study, we increased the standard used to classify the child as an independent rider from 30 feet to more than 100 feet, provided follow-up training on several weekends, and linked the rider with community bicycle riding clubs to help insure that they continue to ride following the formal individualized training. In our most recent study, we successfully trained 62% of children with DS and 94% of children with ASD to ride a two wheel bicycle 100 feet in five days, 75 minutes each day. Most of those who learned were able to ride much longer distances than 100 feet. Participants in our new randomized clinical study, will be in the 9-18 year age range. After random assignment, the experimental group will receive the bicycle intervention training. The control group will receive an incentive towards individualized instruction of their choice that will increase their physical activity. Through learning to ride a two wheel bike, it is expected that the intervention will induce positive changes in functional health related variables including: waist circumference, percent body fat, knee extensor strength, knee flexor strength, level of physical activity, standing balance, participation in the community activities, and psychosocial development. In addition children with ASD are expected to see an improvement in their pattern of sleeping behavior.
- Conditions
- Autism Spectrum Disorder, Down Syndrome
- Being tested
- Bicycle Training Intervention
- Medical subject headings
- Autism Spectrum Disorder, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicycle Training InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group or experimental group will receive the bicycle training intervention during the first year of the study. The intervention is a 5 day/75 minutes per day bicycle training intervention which used specialized instruction and adapted equipment to teach independent bicycle riding skills to youth aged 9-18 years with autism spectrum disorder and Down syndrome. Receives: Behavioral: Bicycle Training Intervention |
| Control group | No intervention | The control group will not receive the intervention during the first year of the study. Instead, this group will receive a delayed intervention during the second year of the study, after pre-post effects have been evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Independent bicycle riding ability
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.
Measured: End of 5 day intervention
Bicycle riding effects on physical activity
Participants will be monitored following learning to ride a two-wheeled bicycle to see if the skill impacts their daily habitual physical activity levels
Measured: 1 and 2 years following intervention
Bicycle riding effects on leg strength
Participants will have their isometric leg strength measured following learning to ride a two-wheels bicycle to see if the skill impacts muscular strength
Measured: 1 and 2 years following intervention
Bicycle riding effects on static balance ability
Participants will have their static balance ability assessed following learning to ride a two-wheeled bicycle to see if the skill impacts balance ability.
Measured: 1 and 2 years following intervention
Secondary outcomes (2)
Participation following learning to ride a two-wheeled bicycle
Participants will be assessed on their participation activities following learning to ride a two-wheeled bicycle.
Measured: 1 and 2 years following intervention
Bicycle riding effects on sleep behavior
Participants will be assessed on their sleeping behavior following learning to ride a two-wheeled bicycle
Measured: 1 and 2 years following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJun 2010
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Dale A Ulrich, University of Michigan
- Investigators
- Dale A Ulrich, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046889
- Sponsor's protocol ID
- CMBDS2012
- Other IDs
- H133G090006
- Status last verified
- Jan 2014
- First submitted
- 18 Feb 2013
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Bicycle Training Intervention on Health, Physical Activity, Sleep & Community Participation in Youth With Down Syndrome & Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02046889
- Acronym / sponsor ID
- CMBDS2012
- Conditions
- Autism Spectrum Disorder, Down Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jan 2014 (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.
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 and ASD groups.
Detailed description
Two-wheel bicycle riding skills are considered a societal norm for children and youth in America as well as a life altering activity (Klein, 2004). Most children learn how to ride a bicycle by the age of 7 years. Children with disabilities often require more time to learn functional motor behavior skills and in order to successfully accomplish these skills, children with disabilities also require specialized instruction. Consequently, many children with disabilities never learn how to ride a two-wheel bicycle. If children with disabilities do learn how to ride a two-wheel bicycle, they tend to learn much later than children without disabilities. In the Down syndrome population, it is estimated that less than 10% ever learn to ride a two wheel bicycle. Learning to ride a two-wheel bicycle allows children to participate in this leisure activity with siblings and peers (Klein, 2004). This is true for children with Down syndrome (DS) and children with Autism Spectrum Disorder (ASD). In our previous research, a specialized adapted bicycle has been successfully used to teach children with Down syndrome how to master this important functional motor skill. In our previous research, we successfully trained 62% of children with DS to ride in 5 days (75 minutes per day for 5 days) and as a result, they displayed significantly less time in sedentary activity and significantly more time in moderate to vigorous activity 12 months following training compared to the control group. Of the 62% of children with DS who learned to ride, 54% were still riding 18-24 months after receiving the training.The children start learning how to ride the two-wheel bicycle on a very stable adapted bicycle (thick roller wheels attached to the rear wheel) and quickly progress towards a standard two-wheel bike. The results of our first bicycle study suggested that the 38% who did not reach mastery of riding a two wheel bike needed more follow up training. In our most recent study, we increased the standard used to classify the child as an independent rider from 30 feet to more than 100 feet, provided follow-up training on several weekends, and linked the rider with community bicycle riding clubs to help insure that they continue to ride following the formal individualized training. In our most recent study, we successfully trained 62% of children with DS and 94% of children with ASD to ride a two wheel bicycle 100 feet in five days, 75 minutes each day. Most of those who learned were able to ride much longer distances than 100 feet. Participants in our new randomized clinical study, will be in the 9-18 year age range. After random assignment, the experimental group will receive the bicycle intervention training. The control group will receive an incentive towards individualized instruction of their choice that will increase their physical activity. Through learning to ride a two wheel bike, it is expected that the intervention will induce positive changes in functional health related variables including: waist circumference, percent body fat, knee extensor strength, knee flexor strength, level of physical activity, standing balance, participation in the community activities, and psychosocial development. In addition children with ASD are expected to see an improvement in their pattern of sleeping behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Bicycle Training InterventionThe intervention group or experimental group will receive the bicycle training intervention during the first year of the study. The intervention is a 5 day/75 minutes per day bicycle training intervention which used specialized instruction and adapted equipment to teach independent bicycle riding skills to youth aged 9-18 years with autism spectrum disorder and Down syndrome. |
| Control group | No intervention | –The control group will not receive the intervention during the first year of the study. Instead, this group will receive a delayed intervention during the second year of the study, after pre-post effects have been evaluated. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosed with Autism spectrum disorder or Down syndrome
- Aged 9-18 years at entry into study
- Cannot independently ride a two-wheeled bicycle
Key exclusion criteria (3 listed)
- Not meeting the inclusion criteria
- Having a condition which would be a safety risk on a bicycle or performing physical activity, including but not limited to a seizure disorder or mobility issue.
- Weighing more than 250 lbs which is the maximum weight allowance for the equipment used during the intervention.
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 |
|---|---|---|
| Bicycle Training Intervention | Behavioural | Intervention group |
Primary outcome
Independent bicycle riding ability
Time frame: End of 5 day intervention
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.
Bicycle riding effects on physical activity
Time frame: 1 and 2 years following intervention
Participants will be monitored following learning to ride a two-wheeled bicycle to see if the skill impacts their daily habitual physical activity levels
Bicycle riding effects on leg strength
Time frame: 1 and 2 years following intervention
Participants will have their isometric leg strength measured following learning to ride a two-wheels bicycle to see if the skill impacts muscular strength
Bicycle riding effects on static balance ability
Time frame: 1 and 2 years following intervention
Participants will have their static balance ability assessed following learning to ride a two-wheeled bicycle to see if the skill impacts balance ability.
2 secondary outcomes
Participation following learning to ride a two-wheeled bicycle
Time frame: 1 and 2 years following intervention
Bicycle riding effects on sleep behavior
Time frame: 1 and 2 years following the intervention
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 28 Jan 2014.
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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.
Dale A Ulrich, PhD principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bicycle Training Intervention in people with Autism Spectrum Disorder and Down Syndrome, run by University of Michigan at 3 sites 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 3 inclusion and 3 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 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Independent bicycle riding ability (time frame: End of 5 day intervention). The study lists 4 primary outcomes in all. 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 28 Jan 2014; AzTrials last refreshed its copy on 27 Oct 2026.