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Early Motor Experience for Down Syndrome

N/A

Recruiting

Research Sponsored by Georgia State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

An appropriate age range of 7-24 months

Be younger than 18 years old

Must not have

The presence of seizure disorders

Non-correctable vision, hearing and heart problems

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 25 months for all three groups

Awards & highlights

No Placebo-Only Group

Summary

This trial will examine if motor, cognitive, and language development in infants with Down syndrome can be improved with gross and fine motor experience.

Who is the study for?

This trial is for infants aged 7-24 months who have been diagnosed with Down syndrome. It's not suitable for those with seizure disorders, uncorrectable vision or hearing issues, heart problems, or any severe medical conditions that would limit their participation.

What is being tested?

The study is testing the impact of specific motor experiences on development in infants with Down syndrome. It will explore how gross motor (like crawling) and fine motor (like grasping) interventions can influence cognitive and language skills.

What are the potential side effects?

Since this trial involves developmental interventions rather than medications, traditional side effects are not applicable. However, there may be risks associated with physical activity which will be monitored by the researchers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 7 and 24 months old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a seizure disorder.

Select...

I have vision, hearing, or heart issues that cannot be fixed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 25 months for all three groups

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~25 months for all three groups

This trial's timeline: 3 weeks for screening, Varies for treatment, and 25 months for all three groups for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bayley cognitive scores

Bayley language scores

Gesture production

Secondary study objectives

Bayley motor scores

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Gross motor interventionExperimental Treatment1 Intervention

Participants will receive a home-based, parent-administered body-weight supported treadmill intervention from about 10 months of age until walking onset.

Group II: Gross and fine motor interventionExperimental Treatment1 Intervention

Besides the body-weight supported treadmill intervention as illustrated above, participants will receive additional fine motor intervention using "sticky mittens" from about 10 months of age for five months.

Group III: ControlActive Control1 Intervention

Participants will not receive specific intervention.

0 / 3Eligibility criteria met