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Treadmill Training and Orthotic Use in Infants With Down Syndrome

This study has been completed.
Sponsor:
Collaborator:
Foundation for Physical Therapy
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00825175
First received: January 15, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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:

MedlinePlus related topics: Down Syndrome
U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Pattern of gross motor development [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • Age at walking onset [ Designated as safety issue: No ]
  • Gait Parameters [ Time Frame: 1 month after walking onset ] [ Designated as safety issue: No ]
  • Time performing upright play skills [ Time Frame: bi-monthly ] [ Designated as safety issue: No ]

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
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
Foundation for Physical Therapy
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, University of Michgan
ClinicalTrials.gov Identifier: NCT00825175     History of Changes
Other Study ID Numbers: HUM00002466
Study First Received: January 15, 2009
Last Updated: January 15, 2009
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
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 22, 2013