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Investigating Trunk Control in Young Children With Down Syndrome

NCT03544840 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-08-22

No results posted yet for this 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.

Conditions

  • Down Syndrome
  • Gross Motor Development Delay

Interventions

OTHER

Physical Therapy Home Program

On the first day of the intervention phase (B), the PI will deliver the dynamic standing home program device (Upsee) to the parent and child. The PI will provide training and education to the parent on the device and home program. At the weekly visit to score outcome measures, the PI will check the fit of the devices, ensure compliance, and answer any questions about the home program. Parents will be encouraged to use the device with their child 5 days per week, 30 minutes per day. Parents will keep a daily log sheet to record duration of device use, activities performed, and subjective observations of the child during the intervention (Appendix K). The PI will collect these log sheets each week. The baseline phases (A1 and A2) will last 4 weeks and the intervention phase (B) will last 6 weeks. Part 2 of the study is expected to last 14 weeks.

Sponsors & Collaborators

  • American Physical Therapy Association

    collaborator OTHER

  • Texas Woman's University

    lead OTHER

Principal Investigators

  • Megan Flores, MPT · Student

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03544840 on ClinicalTrials.gov