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NCT05307523 · ClinicalTrials.gov registry record · NA
Use of Partial Body Weight Support Play Environment to Encourage Mobility and Exploration in Infants With Down Syndrome
A NA study, sponsored by University of Washington.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT05307523: Completed NA study, sponsored by University of Washington.
NCT05307523 is a NA study that has completed, run by University of Washington. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05307523, a NA study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study Summary
To explore the effects of Partial Body Weight Support (PBWS) within an enriched play environment for infants with Down Syndrome (DS), who are not yet walking, to better understand how PWBS may impact their mobility; exploration; and overall activity level. * Hypothesis1 A: Infants will demonstrate increased movement counts on an ActiGraph during intervention compared to a control phase. Hypothesis 1B: Infants will demonstrate a higher frequency of exploratory behaviors during the intervention as compared to a control phase. * Hypothesis 2: Infants will demonstrate an increased rate of improvement in Gross Motor Function Measure scores after the intervention compared to a control phase. * Hypothesis 3: Infants will demonstrate higher parent-reported mastery motivation on the Dimensions of Mastery Questionnaire after the intervention compared to a control phase.
Primary Outcome
Right Ankle mounted accelerometer (Actigraph GT3X+) data were collected at each assessment point. The sensors were placed on the child's right side ankle and covered with wristbands. The sensors were set to capture data in 1-second epochs during all play sessions. Mean activity counts were calculated by categorizing change in vector magnitude movement counts across a 15-second interval, with higher counts representing more lower extremity movement.
Interventions
- DEVICE Enriched Play Environment with Partial Body Weight Support Harness
- OTHER Enriched Play Environment without Partial Body Weight Support Harness
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2022-02-14 |
| Est. Completion | 2023-05-13 |
| Phase | NA |
What the finished NCT05307523 record still lists
NCT05307523 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Enriched Play Environment with Partial Body Weight Support Harness is the first listed.
NCT05307523 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05307523 about?
NCT05307523 is a clinical study titled "Use of Partial Body Weight Support Play Environment to Encourage Mobility and Exploration in Infants With Down Syndrome". To explore the effects of Partial Body Weight Support (PBWS) within an enriched play environment for infants with Down Syndrome (DS), who are not yet walking, to better understand how PWBS may impact their mobility; exploration; and overall activity level. * Hypothesis1 A: Infants will demonstrate ...
What is the current status of trial NCT05307523?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2022-02-14. Estimated completion is 2023-05-13.
What interventions are being tested in trial NCT05307523?
The interventions under investigation include: Enriched Play Environment with Partial Body Weight Support Harness (DEVICE), Enriched Play Environment without Partial Body Weight Support Harness (OTHER).
Who is sponsoring clinical trial NCT05307523?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05307523's enrollment target sits among peer trials
17 1871st of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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