Treadmill Training and Orthotic Use in Infants With Down Syndrome

Study Overview
=================
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.

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.

Official Title
-----------------
The Effect of Treadmill Training and Orthotic Use on the Development of Walking and Upright Play in Infants With Down Syndrome

Conditions
-----------------
Down Syndrome

Intervention / Treatment
-----------------
* Behavioral: Treadmill Training
* Device: Supramalleolar Orthoses


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 36 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Treadmill Training in infants with Down syndrome only | Behavioral: Treadmill Training<br>* 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.<br>|
| Experimental: 2<br>Treadmill Training and supramalleolar orthoses use for infants with Down syndrome | Behavioral: Treadmill Training<br>* 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.<br>Device: Supramalleolar Orthoses<br>* In addition to treadmill training the infants receive Supramalleolar orthoses. They wear the orthoses for 8 hours a day, 5 days a week.<br>* Other names: Orthotics;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Down syndrome, Gait, Motor Development, Orthoses