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Balance Bike Training in Down Syndrome

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ClinicalTrials.gov Identifier: NCT03677245
Recruitment Status : Active, not recruiting
First Posted : September 19, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Mississippi Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Down Syndrome Postural Balance Other: Strider Balance Bike Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
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
Official Title: The Effect of Balance Bike Training on Balance, Physical Activity Levels, and Participation in Children and Youth Down Down Syndrome: a Pilot Study
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Arms and Interventions
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Arm Intervention/treatment
Experimental: Balance Biking
Strider Balance Bike riding for 5 days following the Strider Learn to Ride Curriculum
 Other: Strider Balance Bike
Learning to ride a Strider balance bike


Outcome Measures
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Primary Outcome Measures :
  1. Pediatric Balance Scale (PBS) [ Time Frame: 5 days ]
    The Pediatric Balance Scale (PBS) is a valid, 14-item assessment, developed based on the Berg Balance Scale, to assess balance in children. The PBS is a criterion-based measure, with each item scored on a 0-4 scale. The minimum score possible on the PBS is 0 points. The highest total score possible on the PBS is 56 points.

  2. Distance biked [ Time Frame: 5 days ]
    How far, up to 100', that the child can independently ride their Strider bike

  3. Change in Participation Level based on the Participation and Environment Measure - Children and Youth (PEM-CY) [ Time Frame: 3 months, 6 months ]
    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 PEM-CY asks questions related to 25 types of activiites that take place in the home, school, and community environments. Parents report "how often" their child has participated in each activity over the last 4 months (daily; few times a week; once a week; few times a month; once a month; few times in the last four months; once in the last four months; never); "how involved" their child is when participating in 1 or 2 activities that she or he does most often (5-very involved, 4, 3-somewhat involved, 2, 1-minimally involved); whether or not they want their child's participation to change and how they want it to change. The PEM-CY does not have scale scores or a total score.

  4. Change in Physical Activity based on the Patient Reported Outcome Measure Information System (PROMIS) Physical Activity Measure - Proxy Report [ Time Frame: 3 months, 6 months ]
    PROMIS Physical Activity outcome measures assesses various aspects related to a child's participation in physical activity.The PROMIS measure has 10 items that parents rate on a 5-point likert scale. A 1 indicates that the child participated in the activity "no days", 2 indicates that the child participated in the activity 1 day, 3 indicates that the child participated in the activity 2-3 days, 4 indicates that the child participated in the activity 4-5 days, and 5 indicates that the child participated in the activity 6-7 days. The PROMIS does not contain a total score.


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677245


Locations
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United States, Mississippi
University of Mississippi Wellness Center
Flowood, Mississippi, United States, 39232
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
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Principal Investigator: Meredith Flowers, DPT University of Mississippi Medical Center, School of Physical Therapy
More Information
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Responsible Party: University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT03677245     History of Changes
Other Study ID Numbers: 2018-0070
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn