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Trial record 36 of 312 for:    down syndrome

Treadmill Training and Orthotic Use in Infants With Down Syndrome

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ClinicalTrials.gov Identifier: NCT00825175
Recruitment Status : Completed
First Posted : January 19, 2009
Results First Posted : January 24, 2014
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
Julia Looper, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Down Syndrome
Interventions Behavioral: Treadmill Training
Device: Supramalleolar Orthoses
Enrollment 22
Recruitment Details Recruitment in Winter 2007 for in home intervention.
Pre-assignment Details Subjects were excluded if they previously had worn foot orthoses
Arm/Group Title Treadmill Training Only Treadmill Training and Orthotic Use
Hide Arm/Group Description This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps. This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
Period Title: Overall Study
Started 10 12
Completed 10 7
Not Completed 0 5
Reason Not Completed
Withdrawal by Subject             0             5
Arm/Group Title Treadmill Training Only Treadmill Training and Orthotic Use Total
Hide Arm/Group Description This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps. This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame. Total of all reporting groups
Overall Number of Baseline Participants 10 12 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
<=18 years
10
 100.0%
12
 100.0%
22
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 12 participants 22 participants
12  (2) 12  (2) 12  (2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
Female
4
  40.0%
5
  41.7%
9
  40.9%
Male
6
  60.0%
7
  58.3%
13
  59.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 12 participants 22 participants
10 12 22
1.Primary Outcome
Title Pattern of Gross Motor Development
Hide Description Age in months at walking development as indicated by the Gross Motor Function Measure, a standardized test of gross motor development.
Time Frame monthly; starting when child can pull to stand and ending when the test determined that the child was walking.
Hide Outcome Measure Data
Hide Analysis Population Description
analysis was on protocol
Arm/Group Title Treadmill Training Only Treadmill Training and Orthotic Use
Hide Arm/Group Description:
This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
Overall Number of Participants Analyzed 10 7
Mean (Standard Deviation)
Unit of Measure: months
28.2  (8.3) 28.3  (5.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treadmill Training Only Treadmill Training and Orthotic Use
Hide Arm/Group Description This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps. This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
All-Cause Mortality
Treadmill Training Only Treadmill Training and Orthotic Use
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treadmill Training Only Treadmill Training and Orthotic Use
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Treadmill Training Only Treadmill Training and Orthotic Use
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Julia Looper
Organization: University of Michigan
Phone: 253 534 8499
Responsible Party: Julia Looper, University of Michigan
ClinicalTrials.gov Identifier: NCT00825175     History of Changes
Other Study ID Numbers: HUM00002466
First Submitted: January 15, 2009
First Posted: January 19, 2009
Results First Submitted: August 5, 2011
Results First Posted: January 24, 2014
Last Update Posted: December 4, 2017