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
1 other identifier
interventional
22
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 15, 2009
CompletedFirst Posted
Study publicly available on registry
January 19, 2009
CompletedResults Posted
Study results publicly available
January 24, 2014
CompletedDecember 4, 2017
October 1, 2017
2.3 years
January 15, 2009
August 5, 2011
October 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pattern of Gross Motor Development
Age in months at walking development as indicated by the Gross Motor Function Measure, a standardized test of gross motor development.
monthly; starting when child can pull to stand and ending when the test determined that the child was walking.
Study Arms (2)
1
ACTIVE COMPARATORTreadmill Training in infants with Down syndrome only
2
EXPERIMENTALTreadmill Training and supramalleolar orthoses use for infants with Down syndrome
Interventions
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.
In addition to treadmill training the infants receive Supramalleolar orthoses. They wear the orthoses for 8 hours a day, 5 days a week.
Eligibility Criteria
You may qualify if:
- Trisomy 21
- Able to pull to stand but not walk
You may not qualify if:
- Additional developmental diagnoses
- Uncorrected vision or hearing impairments
- Previous orthotic intervention
- Previous treadmill intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
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.
PMID: 20075148DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
small sample size
Results Point of Contact
- Title
- Julia Looper
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Julia Looper
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Graduate Student
Study Record Dates
First Submitted
January 15, 2009
First Posted
January 19, 2009
Study Start
March 1, 2006
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
December 4, 2017
Results First Posted
January 24, 2014
Record last verified: 2017-10