Investigating Trunk Control in Young Children With Down Syndrome

NCT03544840 | Completed

• 1 other identifier: 20067
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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

Outcome Measures

Primary Outcomes (2)

• Segmental Assessment of Trunk Control

  Assesses seated trunk control in children with neuromotor disorders.

  20 minutes

• Gross Motor Function Measure

  Assesses gross motor skills in children with Down syndrome

  40 minutes

Study Arms (1)

Dynamic Standing Device

EXPERIMENTAL

Home program using the Upsee

Other: Physical Therapy Home Program

Interventions

Physical Therapy Home Program OTHER

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.

Dynamic Standing Device

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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:

• 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.

Sponsors & Collaborators

• Texas Woman's University: lead
• American Physical Therapy Association: collaborator

Study Sites (1)

University of St. Augustine for Health Sciences

Austin, Texas, 78739, United States

Location

Related Publications (4)

• Ulrich DA, Ulrich BD, Angulo-Kinzler RM, Yun J. Treadmill training of infants with Down syndrome: evidence-based developmental outcomes. Pediatrics. 2001 Nov;108(5):E84. doi: 10.1542/peds.108.5.e84.

  PMID: 11694668 BACKGROUND

• Russell D, Palisano R, Walter S, Rosenbaum P, Gemus M, Gowland C, Galuppi B, Lane M. Evaluating motor function in children with Down syndrome: validity of the GMFM. Dev Med Child Neurol. 1998 Oct;40(10):693-701. doi: 10.1111/j.1469-8749.1998.tb12330.x.

  PMID: 9851239 BACKGROUND

• Butler PB, Saavedra S, Sofranac M, Jarvis SE, Woollacott MH. Refinement, reliability, and validity of the segmental assessment of trunk control. Pediatr Phys Ther. 2010 Fall;22(3):246-57. doi: 10.1097/PEP.0b013e3181e69490.

  PMID: 20699770 BACKGROUND

• Ulrich BD. Opportunities for early intervention based on theory, basic neuroscience, and clinical science. Phys Ther. 2010 Dec;90(12):1868-80. doi: 10.2522/ptj.20100040. Epub 2010 Oct 21.

  PMID: 20966210 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Megan Flores, MPT

  Student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: June 4, 2018
• Study Start: July 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)