Trial Outcomes & Findings for Balance Bike Training in Down Syndrome (NCT NCT03677245)
NCT ID: NCT03677245
Last Updated: 2020-04-21
Results Overview
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.
COMPLETED
NA
8 participants
Day 1 and Day 5
2020-04-21
Participant Flow
Participant milestones
| Measure |
Balance Biking
Strider Balance Bike riding for 5 days following the Strider Learn to Ride Curriculum
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Balance Biking
n=8 Participants
Strider Balance Bike riding for 5 days following the Strider Learn to Ride Curriculum
|
|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 5The 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.
Outcome measures
| Measure |
Balance Biking
n=7 Participants
Strider Balance Bike riding for 5 days following the Strider Learn to Ride Curriculum
Strider Balance Bike: Learning to ride a Strider balance bike
|
|---|---|
|
Pediatric Balance Scale (PBS) Mean Group Score
Pre-Intervention (Day 1)
|
48.43 score on a scale
Standard Deviation 4.467
|
|
Pediatric Balance Scale (PBS) Mean Group Score
Post-Intervention (Day 5)
|
49.43 score on a scale
Standard Deviation 3.552
|
PRIMARY outcome
Timeframe: Day 1 and day 5Population: Outcome of distance cycled assessed based on individual change scores (difference between distance cycled on day 1 and day 5). Group mean change scores also reported. No statistical analysis performed.
How far, up to 100', that the child can independently ride their Strider bike
Outcome measures
| Measure |
Balance Biking
n=8 Participants
Strider Balance Bike riding for 5 days following the Strider Learn to Ride Curriculum
Strider Balance Bike: Learning to ride a Strider balance bike
|
|---|---|
|
Distance Biked
Pre-Intervention (Day 1)
|
84 feet
Standard Deviation 30.69
|
|
Distance Biked
Post-Intervention (Day 5)
|
100 feet
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 3 months, 6 monthsPopulation: Data not reported due to not being collected secondary to participants submitting completed PEM-CYs.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 months, 6 monthsPopulation: Data not reported due to participants not submitting completed PROMIS measure reports.
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.
Outcome measures
Outcome data not reported
Adverse Events
Balance Biking
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Meredith Flowers
University of Mississippi Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place