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COMPLETED NA

Investigating Trunk Control in Young Children With Down Syndrome

NCT03544840 · View on ClinicalTrials.gov ↗

Study Summary

Overall, the purpose of this dissertation research is to investigate trunk control in young children with DS. This will be done in three studies: 1. The purpose of the first study is to determine the reliability of the SATCo in young children with DS. The hypothesis is that the SATCo will demonstrate good (κ \> 0.8) interrater and intrarater reliability. 2. The purpose of the second study is to examine the validity of the SATCo with the GMFM-66 and determine whether age and SATCo score predict GMFM-66 score in young children with DS. The hypotheses are that 1) the SATCo will show concurrent validity with the GMFM-66, and 2) both age and SATCo scores will be significant predictors of GMFM-66 scores. 3. The purpose of the third study is to explore the impact of a dynamic standing device (Upsee) on trunk control and motor skills in young children with DS. The hypothesis is that participants will demonstrate a greater change in scores on the SATCo and the GMFM during the dynamic standing home program phase than during the baseline phases.

Interventions

  • OTHER Physical Therapy Home Program

Study Locations (1)

Texas

  • University of St. Augustine for Health Sciences — Austin

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2018-07-01
Est. Completion 2019-01-31
Phase NA

Sponsor

Texas Woman's University

47 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03544840

The ClinicalTrials.gov registry entry for NCT03544840 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Texas Woman's University, which has 47 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Down Syndrome appearing as the primary indexed condition, and to 1 intervention — of which Physical Therapy Home Program is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03544840 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03544840 about?

NCT03544840 is a clinical study titled "Investigating Trunk Control in Young Children With Down Syndrome". Overall, the purpose of this dissertation research is to investigate trunk control in young children with DS. This will be done in three studies: 1. The purpose of the first study is to determine the reliability of the SATCo in young children with DS. The hypothesis is that the SATCo will demonstra...

What is the current status of trial NCT03544840?

This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2018-07-01. Estimated completion is 2019-01-31.

What conditions does trial NCT03544840 study?

This clinical trial studies the following conditions: Down Syndrome, Gross Motor Development Delay. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03544840?

The interventions under investigation include: Physical Therapy Home Program (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03544840?

This trial is sponsored by Texas Woman's University, which has 47 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03544840 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial