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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ mid study (week 5) to final (week 9)

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

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Who is running the clinical trial?

University of WashingtonLead Sponsor

1,747 Previous Clinical Trials

1,847,362 Total Patients Enrolled

Heather Feldner, PT, PhD, PCSPrincipal InvestigatorUniversity of Washingon

Frequently Asked Questions

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

How many participants are currently participating in the experiment?

"Affirmative. According to information posted on clinicaltrials.gov, this trial which commenced on February 14th 2022 is currently recruiting participants. A total of 15 people need to be signed up from a single site."

Answered by AI

Are any participants being accepted at this moment for the research project?

"Affirmative. Clinicaltrials.gov data indicates that this examination is actively seeking participants; the protocol was initially published on February 14th, 2022 and last modified on November 9th, 2022. The study requires 15 enrollees at a single research centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of Partial Body Weight Support Play Environment to Encourage Mobility and Exploration in Infants With Down Syndrome

Heather Feldner 2022. "Use of Partial Body Weight Support Play Environment to Encourage Mobility and Exploration in Infants With Down Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05307523.