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Treadmill Training and Orthotic Use in Infants With Down Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julia Looper, University of Michigan
ClinicalTrials.gov Identifier:
NCT00825175
First received: January 15, 2009
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Down Syndrome
Behavioral: Treadmill Training
Device: Supramalleolar Orthoses

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Treadmill Training and Orthotic Use on the Development of Walking and Upright Play in Infants With Down Syndrome

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Time Performing Upright Play Skills [ Time Frame: bi-monthly; starting when child can pull to stand and ending at walking onset ] [ Designated as safety issue: No ]
    20 minute session of playing in upright. This is video recorded and behavior coded


Enrollment: 22
Study Start Date: March 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Treadmill Training only
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.
Experimental: 2
Treadmill Training and Orthotic use
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.
Other Names:
  • Orthoses
  • Orthotics

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.

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825175

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Julia Looper University of Michigan
  More Information

No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Julia Looper, Graduate Student, University of Michigan
ClinicalTrials.gov Identifier: NCT00825175     History of Changes
Other Study ID Numbers: HUM00002466
Study First Received: January 15, 2009
Results First Received: August 5, 2011
Last Updated: January 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Down syndrome
Gait
Motor Development
Orthoses

Additional relevant MeSH terms:
Down Syndrome
Syndrome
Abnormalities, Multiple
Chromosome Disorders
Congenital Abnormalities
Disease
Genetic Diseases, Inborn
Intellectual Disability
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes

ClinicalTrials.gov processed this record on November 19, 2014