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A Bicycle Training Intervention

Primary Purpose

Autism Spectrum Disorder, Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bicycle Training Intervention
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with Autism spectrum disorder or Down syndrome
  • Aged 9-18 years at entry into study
  • Cannot independently ride a two-wheeled bicycle

Exclusion Criteria:

  • 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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
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
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.

Secondary Outcome Measures

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.
Bicycle riding effects on sleep behavior
Participants will be assessed on their sleeping behavior following learning to ride a two-wheeled bicycle

Full Information

First Posted
February 18, 2013
Last Updated
January 24, 2014
Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02046889
Brief Title
A Bicycle Training Intervention
Official Title
The Effects of a Bicycle Training Intervention on Health, Physical Activity, Sleep & Community Participation in Youth With Down Syndrome & Autism Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Down Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Bicycle Training Intervention
Primary Outcome Measure Information:
Title
Independent bicycle riding ability
Description
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.
Time Frame
End of 5 day intervention
Title
Bicycle riding effects on physical activity
Description
Participants will be monitored following learning to ride a two-wheeled bicycle to see if the skill impacts their daily habitual physical activity levels
Time Frame
1 and 2 years following intervention
Title
Bicycle riding effects on leg strength
Description
Participants will have their isometric leg strength measured following learning to ride a two-wheels bicycle to see if the skill impacts muscular strength
Time Frame
1 and 2 years following intervention
Title
Bicycle riding effects on static balance ability
Description
Participants will have their static balance ability assessed following learning to ride a two-wheeled bicycle to see if the skill impacts balance ability.
Time Frame
1 and 2 years following intervention
Secondary Outcome Measure Information:
Title
Participation following learning to ride a two-wheeled bicycle
Description
Participants will be assessed on their participation activities following learning to ride a two-wheeled bicycle.
Time Frame
1 and 2 years following intervention
Title
Bicycle riding effects on sleep behavior
Description
Participants will be assessed on their sleeping behavior following learning to ride a two-wheeled bicycle
Time Frame
1 and 2 years following the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with Autism spectrum disorder or Down syndrome Aged 9-18 years at entry into study Cannot independently ride a two-wheeled bicycle Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dale A Ulrich, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
City
Southbend
State/Province
Indiana
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Grand Rapids
State/Province
Michigan
Country
United States

12. IPD Sharing Statement

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A Bicycle Training Intervention

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