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

January 15, 2009
January 24, 2014
March 2006
June 2008   (final data collection date for primary outcome measure)
  • 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
  • Pattern of gross motor development [ Time Frame: monthly ] [ 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 ]
  • Age at walking onset [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00825175 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Treadmill Training and Orthotic Use in Infants With Down Syndrome
The Effect of Treadmill Training and Orthotic Use on the Development of Walking and Upright Play 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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
  • Active Comparator: 1
    Treadmill Training only
    Intervention: Behavioral: Treadmill Training
  • Experimental: 2
    Treadmill Training and Orthotic use
    Interventions:
    • Behavioral: Treadmill Training
    • Device: Supramalleolar Orthoses
Looper J, Ulrich DA. Effect of treadmill training and supramalleolar orthosis use on motor skill development in infants with Down syndrome: a randomized clinical trial. Phys Ther. 2010 Mar;90(3):382-90. doi: 10.2522/ptj.20090021. Epub 2010 Jan 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
6 Months to 36 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00825175
HUM00002466
Yes
Julia Looper, University of Michigan
University of Michigan
Not Provided
Principal Investigator: Julia Looper University of Michigan
University of Michigan
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP