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Gait in Children With Down Syndrome While Wearing Orthoses

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ClinicalTrials.gov Identifier: NCT01598350
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : December 30, 2013
Last Update Posted : December 30, 2013
Sponsor:
Information provided by (Responsible Party):
Julia Looper, University of Puget Sound

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Down Syndrome
Intervention Device: Supramalleolar Orthoses (Cascade)
Enrollment 6
Recruitment Details Subjects were recruited from local elementary schools from November 2009 until January 2009
Pre-assignment Details  
Arm/Group Title Orthotic
Hide Arm/Group Description

Orthotic Use

Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial

Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Orthotic
Hide Arm/Group Description

Orthotic Use

Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
6
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
4.5  (.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
2
  33.3%
Male
4
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Step Width
Hide Description [Not Specified]
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Orthotic
Hide Arm/Group Description:

Orthotic Use

Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: cm
10.4  (2.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Orthotic
Hide Arm/Group Description

Orthotic Use

Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial

All-Cause Mortality
Orthotic
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Orthotic
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Orthotic
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Julia Looper, PT PhD
Organization: University of Puget Sound
Phone: 253 879 2895
EMail: jlooper@pugetsound.edu
Layout table for additonal information
Responsible Party: Julia Looper, University of Puget Sound
ClinicalTrials.gov Identifier: NCT01598350     History of Changes
Other Study ID Numbers: 0910-003
First Submitted: January 20, 2010
First Posted: May 15, 2012
Results First Submitted: November 12, 2013
Results First Posted: December 30, 2013
Last Update Posted: December 30, 2013