Balance Bike Training in Down Syndrome
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 5 - 17 |
| Updated: | 12/13/2018 |
| Start Date: | November 26, 2018 |
| End Date: | June 1, 2019 |
The Effect of Balance Bike Training on Balance, Physical Activity Levels, and Participation in Children and Youth Down Down Syndrome: a Pilot Study
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.
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.
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.
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.
Inclusion Criteria:
- be between the ages of 5 and 17 years old with a diagnosis of Down syndrome
- have the core strength and balance necessary to maintain sitting on a two-wheel
balance bike with their feet on the ground
- be able to follow simple commands.
Exclusion Criteria:
- significant cardiovascular event or illness in the past 6 months
- another medical diagnosis, besides Down syndrome, that would limit participation in
the exercise programs.
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