Treadmill Training and Orthotic Use in Infants With Down Syndrome

Down Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825175
• Other study ID #: HUM00002466
• Status: Completed
• Phase: N/A
• First received: January 15, 2009
• Last updated: October 27, 2017
• Start date: March 2006
• Est. completion date: June 2008

Study information

• Verified date: October 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

Inclusion Criteria:

• Trisomy 21

• Able to pull to stand but not walk

Exclusion Criteria:

• Additional developmental diagnoses

• Uncorrected vision or hearing impairments

• Previous orthotic intervention

• Previous treadmill intervention

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pattern of Gross Motor Development	Age in months at walking development as indicated by the Gross Motor Function Measure, a standardized test of gross motor development.	monthly; starting when child can pull to stand and ending when the test determined that the child was walking.