Investigating Trunk Control in Young Children With Down Syndrome

Completed · Not applicable

Conditions studied: Down Syndrome, Gross Motor Development Delay

In brief

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.

Key facts

Study ID

NCT03544840

Run by

Texas Woman's University

People needed

18

Starts

2018-07-01

Expected to finish

2019-01-31

Last updated by the study team

2019-08-22

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of DS. This is the diagnosis that is being investigated
• Speak English. This is the language spoken by the PI.
• Medically stable, without physician- ordered restrictions. Some children with DS have cardiac surgery or other complications that would contraindicate handling or movement. These children would not be considered medically stable.
• Between the age of 6 to 24 months. This captures the full range of the outcome measure being investigated.

You may not qualify if…

• Meet inclusion and exclusion criteria for part 1 of the study. Children for part 2 of the study will be a sub-sample of those in part 1 of the study.
• Between the age of 9 to 18 months. This captures the age when most children with DS are able to bear weight through their lower extremities, but before they can walk independently. This is necessary to be able to use the home programs and demonstrate gross motor changes.
• Unable to ambulate independently. Children who can walk independently cannot use the home program devices.

Where it is running

• University of St. Augustine for Health Sciences — Austin, Texas, United States

Full record on ClinicalTrials.gov

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