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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):

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

  Participant Flow

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

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 
Overall Participants Analyzed 
[Units: Participants]
 10   12   22 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 12  (2)   12  (2)   12  (2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  40.0%      5  41.7%      9  40.9% 
Male      6  60.0%      7  58.3%      13  59.1% 
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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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