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Treadmill Training and Orthotic Use in Infants With Down Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00825175
First Posted: January 19, 2009
Last Update Posted: December 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Julia Looper, University of Michigan
  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
Intervention Model: Parallel Assignment
Masking: None (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 Julia Looper, 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. ]
    Age in months at walking development as indicated by the Gross Motor Function Measure, a standardized test of gross motor development.


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 in infants with Down syndrome 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 supramalleolar orthoses use for infants with Down syndrome
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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 15, 2009
First Posted: January 19, 2009
Results First Submitted: August 5, 2011
Results First Posted: January 24, 2014
Last Update Posted: December 4, 2017
Last Verified: October 2017

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

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