Treadmill Training and Orthotic Use in Infants With Down Syndrome

Not Applicable

Completed

• Conditions: Down Syndrome
• Interventions: Behavioral: Treadmill Training; Device: Supramalleolar Orthoses

• Registration Number: NCT00825175
• Lead Sponsor: University of Michigan

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 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.

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-01-15
• Study First Posted: 2009-01-19
• Results First Submitted: 2011-08-05
• Results First Submitted QC: 2013-12-09
• Results First Posted: 2014-01-24
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-27
• Last Update Posted: 2017-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Treadmill Training	Treadmill Training in infants with Down syndrome only
2	Treadmill Training	Treadmill Training and supramalleolar orthoses use for infants with Down syndrome
2	Supramalleolar Orthoses	Treadmill Training and supramalleolar orthoses use for infants with Down syndrome

Primary Outcome Measures

Name	Time	Method
Pattern of Gross Motor Development	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States