Balance Bike Training in Down Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03677245|
Recruitment Status : Active, not recruiting
First Posted : September 19, 2018
Last Update Posted : December 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Down Syndrome Postural Balance||Other: Strider Balance Bike||Not Applicable|
Show Detailed Description
|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)|
|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|
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
- 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.
- Distance biked [ Time Frame: 5 days ]How far, up to 100', that the child can independently ride their Strider bike
- 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.
- 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.
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
|United States, Mississippi|
|University of Mississippi Wellness Center|
|Flowood, Mississippi, United States, 39232|
|Principal Investigator:||Meredith Flowers, DPT||University of Mississippi Medical Center, School of Physical Therapy|