Treadmill Training and Orthotic Use in Infants With Down Syndrome

October 27, 2017 updated by: Julia Looper, University of Michigan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
monthly; starting when child can pull to stand and ending when the test determined that the child was walking.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Julia Looper, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

January 15, 2009

First Submitted That Met QC Criteria

January 15, 2009

First Posted (ESTIMATE)

January 19, 2009

Study Record Updates

Last Update Posted (ACTUAL)

December 4, 2017

Last Update Submitted That Met QC Criteria

October 27, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00002466

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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