A Bicycle Training Intervention
Condition: Autism Spectrum Disorder; Down Syndrome
MeSH terms: Down Syndrome; Syndrome; Autism Spectrum Disorder
Study type: Interventional

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.
    

Intervention name(s): Bicycle Training Intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment