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Completed

NCT Number: NCT00825175

Treadmill Training and Orthotic Use in Infants With Down Syndrome

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treadmill training

Behavioral

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.

Supramalleolar Orthoses

Device

In addition to treadmill training the infants receive Supramalleolar orthoses. They wear the orthoses for 8 hours a day, 5 days a week.

Other names: Orthoses, Orthotics

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 19, 2009
Registry last updated
Dec 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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