Treadmill Training and Orthotic Use in Infants With Down Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julia Looper, University of Michigan
ClinicalTrials.gov Identifier:
NCT00825175
First received: January 15, 2009
Last updated: January 24, 2014
Last verified: January 2014
Results First Received: August 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Down Syndrome
Interventions: Behavioral: Treadmill Training
Device: Supramalleolar Orthoses

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment in Winter 2007 for in home intervention.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were excluded if they previously had worn foot orthoses

Reporting Groups
  Description
Treadmill Training Only 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.
Treadmill Training and Orthotic Use 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.

Participant Flow:   Overall Study
    Treadmill Training Only     Treadmill Training and Orthotic Use  
STARTED     10     12  
COMPLETED     10     7  
NOT COMPLETED     0     5  
Withdrawal by Subject                 0                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treadmill Training Only 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.
Treadmill Training and Orthotic Use 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 Total of all reporting groups

Baseline Measures
    Treadmill Training Only     Treadmill Training and Orthotic Use     Total  
Number of Participants  
[units: participants]
  10     12     22  
Age  
[units: participants]
     
<=18 years     10     12     22  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  12  ± 2     12  ± 2     12  ± 2  
Gender  
[units: participants]
     
Female     4     5     9  
Male     6     7     13  
Region of Enrollment  
[units: participants]
     
United States     10     12     22  



  Outcome Measures

1.  Primary:   Pattern 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. ]

2.  Primary:   Gait Parameters   [ Time Frame: 1 month after walking onset ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Primary:   Time Performing Upright Play Skills   [ Time Frame: bi-monthly; starting when child can pull to stand and ending at walking onset ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
small sample size


  More Information
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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
e-mail: jlooper@umich.edu


No publications provided by University of Michigan

Publications automatically indexed to this study:

Responsible Party: Julia Looper, University of Michigan
ClinicalTrials.gov Identifier: NCT00825175     History of Changes
Other Study ID Numbers: HUM00002466
Study First Received: January 15, 2009
Results First Received: August 5, 2011
Last Updated: January 24, 2014
Health Authority: United States: Institutional Review Board