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Enriched Environment Play With Harness Support for Down Syndrome

N/A
Waitlist Available
Led By Heather Feldner, PT, PhD, PCS
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up mid study (week 5) to final (week 9)
Awards & highlights

Study Summary

This trialis testing if Partial Body Weight Support in a play environment can help infants with Down Syndrome move better, explore more, and have higher levels of activity.

Eligible Conditions
  • Down Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~mid study (week 5) to final (week 9)
This trial's timeline: 3 weeks for screening, Varies for treatment, and mid study (week 5) to final (week 9) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Caregiver Perception of Their Child's Mastery Motivation Using the Revised Dimensions of Mastery Questionnaire-18 Infant Version From Baseline (Week 1) to Final (Week 9)
Change in Caregiver Perception of Their Child's Mastery Motivation Using the Revised Dimensions of Mastery Questionnaire-18 Infant Version From Baseline (Week 1) to Mid Study (Week 5)
Change in Caregiver Perception of Their Child's Mastery Motivation Using the Revised Dimensions of Mastery Questionnaire-18 Infant Version From Mid Study (Week 5) to Final (Week 9)
+6 more
Secondary outcome measures
Change in Percentage of Time Spent in Upright (on Feet) Between Baseline (Week 1) and Final Study (Week 9)
Change in Percentage of Time Spent in Upright (on Feet) Between Baseline (Week 1) and Mid Study (Week 5)
Change in Percentage of Time Spent in Upright (on Feet) Between Mid Study (Week 5) and Final (Week 9)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Enriched Environment Play With Harness SupportExperimental Treatment1 Intervention
Enriched environment play, movement, and exploration for children with Down Syndrome while using a portable partial body weight support harness to facilitate movement and exploration.
Group II: Enriched Environment Play Without Harness SupportActive Control1 Intervention
Enriched environment play, movement, and exploration without additional partial body weight support provided.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enriched Play Environment with Partial Body Weight Support Harness
2022
N/A
~20

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,749 Previous Clinical Trials
1,838,627 Total Patients Enrolled
Heather Feldner, PT, PhD, PCSPrincipal InvestigatorUniversity of Washingon
~5 spots leftby Jun 2025
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