Clinical Trial: Treadmill Training and Orthotic Use in Infants With Down Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effect of Treadmill Training and Orthotic Use on the Development of Walking and Upright Play in Infants With Down Syndrome

Brief Summary: This study determines the effect of orthotic use in combination with treadmill training on the development of gross motor skills and walking onset in infants with Down syndrome.

Detailed Summary: The goal of this study is to determine if orthotic use impacts the development of walking and upright play skills over and above the impact that treadmill training alone has. Infants with Down syndrome who can pull to stand but not walk will be recruited and assigned to a group that receives treadmill training and orthoses or just treadmill training. The infants are followed monthly until they have one month of walking experience. During the monthly visits, the infants' gross motor development is tested and their upright play behavior is observed. At the end of the study each infants gait is evaluated. We believe that the orthoses will lead to a decreased age at walking onset, an improvement in gait patterns, and an improvement in upright play ability.
Sponsor: University of Michigan

Current Primary Outcome:

  • 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. ]
    Age in months at walking development as indicated by the Gross Motor Function Measure, a standardized test of gross motor development.
  • Gait Parameters [ Time Frame: 1 month after walking onset ]
  • Time Performing Upright Play Skills [ Time Frame: bi-monthly; starting when child can pull to stand and ending at walking onset ]
    20 minute session of playing in upright. This is video recorded and behavior coded


Original Primary Outcome:

  • Pattern of Gross Motor Development [ Time Frame: monthly ]
  • Age at walking onset
  • Gait Parameters [ Time Frame: 1 month after walking onset ]
  • Time Performing Upright Play Skills [ Time Frame: bi-monthly ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Michigan

Dates:
Date Received: January 15, 2009
Date Started: March 2006
Date Completion:
Last Updated: January 24, 2014
Last Verified: January 2014