Balance Bike Training in Down Syndrome
Condition: Down Syndrome; Postural Balance
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      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 10 children between the ages of 5 and 17 years old will be recruited to
      participate in this 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 PROMIS physical activity questionnaire.
    

Detailed description: 
      The proposed pilot study is a pre- post-test design with each participant serving as his or
      her own control. Children and adolescents with Down syndrome will be recruited from pediatric
      physical therapy clinics, local school districts, and the Central Mississippi Down Syndrome
      Association. Flyers will be provided to local pediatric therapy clinics and school districts.
      The director of the Central Mississippi Down Syndrome Association will be contacted by the PI
      (see email attached) and asked to send out a target recruitment email to all families of
      children with Down syndrome that are on the Central Mississippi Down Syndrome Association
      email list. 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. 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 exercise programs. The
      Institutional Review Board at the University of Mississippi Medical Center will approve all
      procedures. Each participant will complete an assent form to participate. Each participant
      will complete an assent and each parent/caregiver will complete an informed consent prior to
      enrolling their child in the study. If the child is unable to provide assent, due to age
      and/or cognitive deficits, only parental permission will be obtained. Additionally, each
      participant's parent/caregiver will be asked to complete the "registration packet" (attached
      to the IRB) in order to provide the researchers with health-related information that may be
      needed to ensure participant safety during the intervention sessions. The registration packet
      will only be viewed by the PI and co-investigator and will not be directly linked with any
      PHI to be created during the study. The Strider "Learn to Ride" intervention is designed to
      accommodate up to 10 children per intervention class, therefore no more than 10 participants
      will be recruited for the initial pilot study.

      Outcome measures used will include the Pediatric Balance Scale (PBS), distance cycled,
      Participation and Environment Measure-Children and Youth (PEM-CY), and the PROMIS Physical
      Activity 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.
      Previous research has used 100' as the distance criteria to identify mastery. The PEM-CY is
      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 DS. The
      parent/proxy PROMIS Physical Activity outcome measures assesses various aspects related to a
      child's participation in physical activity. Follow-up questionnaires (PEM-CY and PROMIS) will
      be sent by mail from the PI to the parent/caregiver to assess long-term changes in
      participation, time spent engaged in physical activity, and sustainability of the Strider
      bike intervention.

      One the first day of the intervention, each participant will be assessed with the PBS to
      determine baseline balance ability. The initial straight-line distance, up to 100 feet, that
      each child can independently and safely ride their Strider balance bike will also be
      recorded. Additionally, each participants' parent/caregiver will be asked to complete the
      PEM-CY and the PROMIS questionnaire. This initial data collected will serve as each
      participants' baseline data. Each child will participate in five, consecutive, two-hour
      adaptive bike training sessions with instruction guided by the Strider "Learn to Ride"
      intervention. Each session will have no more than 10 participants. The biking sessions will
      be under the direct instruction of a pediatric physical therapist (the PI, Meredith Flowers)
      who has completed the certification to teach Strider "Learn to Ride" classes. Each session
      will take place in an indoor gym or paved, outdoor facility. Each participant will be fitted
      with an adaptive Strider bike to use for the duration of the 5-day intervention and to take
      home as their own, to encourage carry over, at the end of the training period. Each
      participant will also be required to provide and wear an appropriately fitted bike helmet
      when engaged in bike riding. Each session will begin with a 5-10-minute warm up, followed by
      at least 60 total minutes of riding activities based on the proven Strider "Learn to Ride"
      intervention. Individual participants will be allowed to take rest breaks as needed. Each
      session will conclude with 5-10 minutes of cool down activities. On the final day of the
      intervention, each participant will again be assessed with the PBS. The distance that each
      participant can safely and independently propel their Strider bike will be assessed and
      recorded. Each child's parent/caregiver will be contacted by mail from the PI to complete
      follow-up assessments at 3-, 6 months following completion of the initial intervention
      period. Outcome measures used for long-term follow up include the PEM-CY and PROMIS
      questionnaire. The PI and co-PI, both licensed physical therapists, will be assessing all
      participants.

      IBM SPSS Statistics program will be used for all data analysis. Dependent t-tests will be
      used to analyze pre- and post-test scores of the PBS, PEM-CY, PROMIS and distance cycled. If
      the assumptions for the dependent t-test are not met, a Wilcoxon signed ranks test will be
      used to analyze the data.
    

Intervention name(s): Strider Balance Bike
Intervention type(s): Other
Intervention description(s): Learning to ride a Strider balance bike
Intervention model: Single Group Assignment
Intervention model description: pre- post-test design with each participant serving as his or her own control
Masking: None (Open Label)
Primary purpose: Treatment