The Effect of Balance Bike Training on Balance, Physical Activity Levels, and Participation in Children and Youth Down Down Syndrome: a Pilot Study
Phase: NA
Conditions: Down Syndrome, Postural Balance
Sponsor: University of Mississippi Medical Center

 
 
The Effect of Balance Bike Training on Balance, Physical Activity Levels, and 
Participation in Children and Youth with Down Syndrome: A Pilot Study 
 
NCT #: NCT03677245 
 
Date: 9.4.2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

RESEARCH PROTOCOL AND STATISTICAL ANALYSIS PLAN 
 
TITLE 
The Effect of Balance Bike Training on Balance, Physical Activity 
Levels, and Participation in Children and Youth with Down 
Syndrome: A Pilot Study 
ABSTRACT 
Background: Children with Down syndrome (DS) present with 
hypotonia, impaired balance and poor gross motor proficiency 
which lead to difficulty learning new motor skills, decreased 
engagement in physical activity, and limited participation in home, 
school, and community activities. Bicycle riding is a popular 
childhood activity with multiple health benefits; however, children 
with DS often have difficulty learning to ride a standard two-wheel 
bike. Purpose: The purpose of this pilot study is to determine the 
effectiveness of the Strider “Learn to Ride” intervention when 
used to teach children with DS to ride a two-wheel balance bike. 
Additional purposes include examining the immediate effects of 
the five-day “Learn to Ride” intervention on the balance of 
children with DS and the long-term effects of completion of the 
intervention on the participation and physical activity levels of 
children with DS. Methods: An estimated 20 children between the 
ages of 5 and 17 years old will be recruited to participate in the 
quasi-experimental, pre-post-test group design study. The 
participants will complete the five-day Strider “Learn to Ride” 
intervention under the instruction of a pediatric physical therapist. 
The immediate effects of the intervention on distance cycled and 
balance, using the Pediatric Balance Scale (PBS), will be 
assessed. Participation and physical activity levels will be 
assessed at long term follow-up using the Participation and 
Environment Measure for Children and Youth (PEM-CY) and a 
parent-report questionnaire. 
BACKGROUND 
Bicycle riding is a popular childhood activity; however, individuals 
with Down syndrome (DS)often have difficulty mastering this skill. 
Down syndrome, a common chromosomal disorder identified in 
approximately 1 in 700 live births, carries the certainty of 
developmental delay and altered gross motor movement 
proficiency.1Individuals with DS present with cerebellar 
hypoplasia which contributes to delayed motor skills, problems 
with axial control, and impaired coordination.2Additionally, a 
reported 58% of children and adolescents with DS do not meet 
the Office of Disease Prevention and Health Promotion’s PA 
guidelines, and evidence suggests that PA levels continue to 
decrease as children move into adolescence.3Additional 
characteristics of children with DS contributing to physical 
inactivity and difficulty learning to ride two-wheel bikes include 
cognitive impairments, hypotonia, balance impairments, and 
reduced exercise capacity.4,5Societal and environmental barriers 
to PA, including limited opportunities for participation in inclusive 
sports and high costs of adaptive equipment also contribute to 

low fitness levels of this population. Identification of enjoyable, 
sustainable, accessible, and effective forms of PA for this 
population is necessary in order to promote improved overall 
health and participation across the lifespan. Bicycle riding has 
been identified as a source of moderate to vigorous PA for 
children and adolescents and is a noncompetitive, highly 
accessible activity that can be enjoyed across the 
lifespan.6,7However, research examining bike riding as an 
enjoyable and effective PA intervention for adolescents with 
developmental disabilities, particularly DS, is limited. One study 
examined the benefits of children with DS learning to ride an 
adaptive two-wheel bicycle.8The children participated in “Lose the 
Training Wheels”, an intensive, five-day program aimed at 
teaching the skill of riding a two-wheel bike 
independently.8Specially designed two-wheel adaptive bikes were 
used for initial training. The bikes were modified to include a push 
handle on the back, to be used by the instructor, and rear roller 
wheels to increase the bike’s base of support.8Forty-four percent 
of the participants were unable to learn to ride a two-wheel bike 
during the training period.8However, children who did complete 
the training program decreased their time spent in sedentary 
behavior by 75 minutes per day, indicating that new motor skill 
development might positively impact PA levels for up to 12 
months following the initial intervention period.8A similar study 
also examined the effectiveness of the “Lose the Training 
Wheels” program, previously described, for children and 
adolescents with DS and Autism Spectrum Disorder.6The results 
indicated that 61% of children with DS continued to ride their bike 
at home after the intervention period ended, supporting transfer of 
an enjoyable PA to the natural environment.6However, the 
adaptive bikes used for the “Lose the Training Wheels” program 
are specially made and not commercially available, making 
widespread access to this intervention difficult. Strider Bikes, a 
brand of commercially available balance bikes, are specifically 
designed to be lightweight, easy to handle, and safe for use with 
children with disabilities. One study using Strider bikes reported 
that children with autism spectrum disorder demonstrated 
significant improvements in postural control following completion 
of 15 minutes of riding, three days per week for five 
weeks.9However, there is currently no research available that has 
utilized Strider bikes with youth with DS. In order to impact a large 
population of children with DS and create lasting, positive 
outcomes, a relatively inexpensive, commercially available 
adaptive bike and effective instructional intervention must be 
identified.  
PURPOSE 
The purpose of this pilot study is to determine the effectiveness of 
the Strider “Learn to Ride” intervention on the balance of children 
with Down syndrome and the long-term effects of completion of 

the intervention on the participation and physical activity levels of 
children with Down syndrome. Our central hypothesis is that 
successful completion of the Strider “Learn to Ride” intervention 
will provide children with Down syndrome the ability to ride a two-
wheel balance bike safely and independently. We also 
hypothesize that balance biking will be a sustainable activity that 
has the potential to greatly increase the functional balance, 
participation, and physical activity levels of youth with Down 
syndrome because we propose riding Strider bikes to be 
enjoyable and motivating for this population. 
SPECIFIC AIM(S) 
Page 4of 74/5/2019Specific Aim(s)We plan to test our central 
hypothesis and meet our overall objective for this project by 
pursuing the following specific aims:1. Determine the ability of 
youth with DS to learn to ride a Strider balance bike, within one 
week, utilizing the Strider “Learn to Ride” curriculum. Our working 
hypothesis is that youth with DS who complete the five “Learn to 
Ride” classes will be able to successfully and safely ride their 
Strider bike 100’ or more without loss of balance. 2. Determine 
the efficacy of balance biking on improving balance in youth with 
DS, as measured by the Pediatric Balance Scale (PBS). Our 
working hypothesis that balance will be improved in youth with 
DS who complete the balance biking intervention because biking 
is an enjoyable childhood PA that requires high levels of postural 
control. 3.Determine the long-term sustainability of balance biking 
for youth with DS, as estimated by a 3-, 6-, 9-, and 12-month 
follow up surveys. Our working hypothesis here is that balance 
biking will be a sustainable form of PA for individuals with DS that 
can be continued throughout the lifespan, leading to increased 
PA levels and decreased time spent engaged in sedentary 
behaviors.4. Determine the impact of long-term participation in 
balance biking on home, school, and community participation 
levels, as measured by the Participation and Environment 
Measure for Children and Youth (PEM-CY).Our working 
hypothesis that long-term involvement in a balance biking 
program will lead to increased participation in home, school, and 
community environments. 
STUDY DESIGN 
The proposed pilot study is a pre-post-test design with each 
participant serving as his or her own control. The proposed study 
design will provide preliminary data towards answering the 
hypothesis and specific aims. Children ages 5-17 years old with a 
diagnosis of Down syndrome will be recruited to participate from 
pediatric therapy clinics, schools, and the Central Mississippi 
Down Syndrome Association. Each participant will be provided 
with a Strider balance bike to use for the intervention. On the first 
day of the intervention, each participant will complete the 
Pediatric Balance scale and the distance that each child can 
cycle will be recorded. Participants’ parents will be asked to 
complete the Participation and Environment Measure for Children 

and Youth (PEM-CY) and the PROMIS physical activity 
questionnaire on the first day of the intervention. Each participant 
will complete the 5-day Strider Learn to Ride Intervention under 
the supervision of a physical therapist. On the last day, each child 
will be reassessed with the Pediatric Balance Scale and the 
distance that each participant can cycle will again be recorded. 
Participants’ caregivers will be contacted by mail from the PI to 
complete follow up outcome measures (PEM-CY and PROMIS 
questionnaire) at 3-and6-months. 
INCLUSION 
CRITERIA 
To be included in the study, the individuals must 1) be between 
the ages of 5 and 17 years old with a diagnosis of Down 
syndrome, 2) have the core strength and balance necessary to 
maintain sitting on a two-wheel bike with their feet on the ground, 
and 3) be able to follow simple commands. 
EXCLUSION 
CRITERIA 
The exclusion criteria for the study are 1) significant 
cardiovascular event or illness in the past 6 months and 2) 
another medical diagnosis, besides Down syndrome, that would 
limit participation in the biking intervention. 
NUMBER OF 
SUBJECTS 
Approximately 10 participants will be recruited to participate in the 
pilot study, based on the recommended number of participants for 
each Strider “Learn to Ride” intervention. 
OUTCOME 
MEASURES 
Outcome measures used will include the Pediatric Balance Scale 
(PBS), distance cycled, Participation and Environment Measure 
for Children and Youth (PEM-CY), and PROMIS questionnaire. 
The PBS is a valid, 14-item assessment, developed based on the 
Berg Balance Scale. The PBS is a criterion-based measure, with 
each item scored on a 0-4 scale. Distance cycled will be 
measured based on the longest straight-line distance, out of three 
trials, that the participant is able to safely and independently 
propel their Strider bike. The PEM-CY is a participation level 
outcome measure used to assess a child’s engagement in 
activities in the home, school, and community environments. The 
PEM-CY is a valid and reliable measure and is completed by 
parent/caregiver report, making it appropriate to use with children 
with Down syndrome. The final outcome measure, a parent report 
PROMIS questionnaire to assess PA levels of participants, will 
also be used. Long-term follow up at 3-and 6 months, through 
mail, will be completed to assess long-term changes in 
participation and physical activity levels as well as the 
sustainability of the Strider bike intervention for this population. 
STUDY ENDPOINTS 
All outcomes measures will be administered on the first day of the 
intervention to collect pre-intervention data. Upon completion of 
the five-day “Learn to Ride” intervention, the Pediatric Balance 
Scale and distance cycled will again be administered for post-
intervention data. The Participation and Environment Measure for 
Children and Youth and the PROMIS physical activity 
questionnaire will be administered, my mail, to each participants’ 
caregiver/parent at 3-and-6-months following completion of the 

intervention to assess long-term outcomes associated with the 
intervention. 
STATISTICAL 
METHODOLOGY 
IMB SPSS Statistics will be used to analyze all data. Dependent t-
tests will be used to analyze pre-and post-test scores of the 
Pediatric Balance Scale, Participation and Environment Measure 
for Children and Youth, and distance cycled. If assumptions are 
not met, a Wilcoxon Signed Ranks test will be used to analyze 
the data. 
REFERENCES  
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perform sufficient physical activity to maintain good health? A 
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http://health.gov/paguidelines/guidelines/chapter3.aspx. 
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