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Treadmill Training and Orthotic Use in Infants With Down Syndrome

University of Michigan logo

University of Michigan

Status

Completed

Conditions

Down Syndrome

Treatments

Behavioral: Treadmill Training
Device: Supramalleolar Orthoses

Study type

Interventional

Funder types

Other

Identifiers

NCT00825175
HUM00002466

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

6 to 36 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

22 participants in 2 patient groups

1
Active Comparator group
Description:
Treadmill Training in infants with Down syndrome only
Treatment:
Behavioral: Treadmill Training
2
Experimental group
Description:
Treadmill Training and supramalleolar orthoses use for infants with Down syndrome
Treatment:
Behavioral: Treadmill Training
Device: Supramalleolar Orthoses

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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