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Treadmill Training and Orthotic Use in Infants With Down Syndrome

NCT ID: NCT00825175

Last Updated: 2017-12-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Down Syndrome

Keywords

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Down syndrome Gait Motor Development Orthoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Treadmill Training in infants with Down syndrome only

Group Type ACTIVE_COMPARATOR

Treadmill Training

Intervention Type BEHAVIORAL

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.

2

Treadmill Training and supramalleolar orthoses use for infants with Down syndrome

Group Type EXPERIMENTAL

Treadmill Training

Intervention Type BEHAVIORAL

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.

Supramalleolar Orthoses

Intervention Type DEVICE

In addition to treadmill training the infants receive Supramalleolar orthoses. They wear the orthoses for 8 hours a day, 5 days a week.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type DEVICE

Other Intervention Names

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Orthoses Orthotics

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Julia Looper

Graduate Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julia Looper

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20075148 (View on PubMed)

Other Identifiers

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HUM00002466

Identifier Type: -

Identifier Source: org_study_id