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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 25 months for all three groups
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bayley cognitive scores
Bayley language scores
Gesture production
Secondary outcome measures
Bayley motor scores

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.

Find a Location

Who is running the clinical trial?

Georgia State UniversityLead Sponsor
57 Previous Clinical Trials
25,384 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,752 Total Patients Enrolled
16 Trials studying Down Syndrome
145,379 Patients Enrolled for Down Syndrome

Media Library

Gross and fine motor intervention Clinical Trial Eligibility Overview. Trial Name: NCT05144373 — N/A
Down Syndrome Research Study Groups: Gross motor intervention, Gross and fine motor intervention, Control
Down Syndrome Clinical Trial 2023: Gross and fine motor intervention Highlights & Side Effects. Trial Name: NCT05144373 — N/A
Gross and fine motor intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05144373 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being enrolled in this trial?

"Affirmative. Clinicaltrials.gov verifies that this research project, which was posted on August 2nd 2022, is actively recruiting participants currently. A total of 45 individuals need to be sourced from 1 centre."

Answered by AI

What is the eligibility criteria for participation in this clinical experiment?

"This clinical trial is accepting applications from candidates of 7 months to 24 months old with Down syndrome; a total of 45 patients are needed."

Answered by AI

Does this experiment accept participants beneath the age of 45?

"According to the trial's entry requirements, infants at least 7 months old and up to 2 years of age can be enrolled in this clinical experiment."

Answered by AI

Is enrollment still available for this study?

"Clinicaltrials.gov reveals that this study, first published on August 2nd 2022 and edited as recently as September 8th 2022, is currently calling for volunteers to join the trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Role of Early Motor Experience in Infants With Down Syndrome
Jianhua Wu 2022. "Role of Early Motor Experience in Infants With Down Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05144373.
All > Down Syndrome
~6 spots leftby Aug 2024
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