Trial Outcomes & Findings for Gait in Children With Down Syndrome While Wearing Orthoses (NCT NCT01598350)
NCT ID: NCT01598350
Last Updated: 2013-12-30
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
60 minutes
Results posted on
2013-12-30
Participant Flow
Subjects were recruited from local elementary schools from November 2009 until January 2009
Participant milestones
| Measure |
Orthotic
Orthotic Use
Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gait in Children With Down Syndrome While Wearing Orthoses
Baseline characteristics by cohort
| Measure |
Orthotic
n=6 Participants
Orthotic Use
Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial
|
|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
4.5 years
STANDARD_DEVIATION .71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 minutesOutcome measures
| Measure |
Orthotic
n=6 Participants
Orthotic Use
Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial
|
|---|---|
|
Step Width
|
10.4 cm
Standard Deviation 2.8
|
Adverse Events
Orthotic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place