Balance Bike Training in Down Syndrome

NCT03677245 | Completed Results

• 1 other identifier: 2018-0070
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome; Postural Balance

Outcome Measures

Primary Outcomes (4)

• Pediatric Balance Scale (PBS) Mean Group Score

  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. Higher scores indicates better balance performance.The score reported is the mean PBS score of the group on day 5, the last day of the intervention.

  Day 1 and Day 5

• Distance Biked

  How far, up to 100', that the child can independently ride their Strider bike

  Day 1 and day 5

• Change in Participation Level Based on the Participation and Environment Measure - Children and Youth (PEM-CY)

  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.

  3 months, 6 months

• Change in Physical Activity Based on the Patient Reported Outcome Measure Information System (PROMIS) Physical Activity Measure - Proxy Report

  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.

  3 months, 6 months

Study Arms (1)

Balance Biking

EXPERIMENTAL

Strider Balance Bike riding for 5 days following the Strider Learn to Ride Curriculum

Other: Strider Balance Bike

Interventions

Strider Balance Bike OTHER

Learning to ride a Strider balance bike

Balance Biking

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• significant cardiovascular event or illness in the past 6 months
• another medical diagnosis, besides Down syndrome, that would limit participation in the exercise programs.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Wellness Center

Flowood, Mississippi, 39232, United States

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Results Point of Contact

• Title: Dr. Meredith Flowers
• Organization: University of Mississippi Medical Center

mmflowers@umc.edu

662-386-5926

Study Officials

• Meredith Flowers, DPT

  University of Mississippi Medical Center, School of Physical Therapy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pre- post-test design with each participant serving as his or her own control

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 19, 2018
• Study Start: November 26, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 21, 2020
• Results First Posted: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)