NCT00825175

Treadmill Training and Orthotic Use in Infants With Down Syndrome

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 6 Months – 36 Months
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Down Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Treadmill Training	Parents hold their infants on an infant treadmill for 8 minutes a day, 5 days a week. The treadmill speed is set at 0.2 m/s.
DEVICE	Supramalleolar Orthoses	In addition to treadmill training the infants receive Supramalleolar orthoses. They wear the orthoses for 8 hours a day, 5 days a week.

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2009-01-19
• Last updated: 2017-12-04
• Results posted: 2014-01-24

Locations

1 site across 1 country: United States