Investigating Trunk Control in Young Children With Down Syndrome
Condition: Down Syndrome; Gross Motor Development Delay
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

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.
    

Detailed description: 
      Literature suggests there is a need to identify effective home programs to supplement
      physical therapy and improve gross motor function in children with Down syndrome (DS). To
      study the impact of home programs, effective tools must be employed to measure the
      incremental changes that occur in young children with DS, both at the body structure and
      function level and the activity level of the World Health Organization's International
      Classification of Functioning, Disability and Health (ICF). The Gross Motor Function Measure
      (GMFM-66) is an effective measure of motor skills at the activity level of the ICF for
      children with DS; however, there is a lack of sound outcome measures of trunk control for
      young children with DS. The Segmental Assessment of Trunk Control (SATCo) may be an effective
      tool for this purpose but has not been studied in this population.

      In addition to assessing trunk control in children with DS, intervention strategies for
      improving trunk control in this population must be investigated. A home program using upright
      mobility through treadmill training has proven to be effective in accelerating the
      acquisition of motor skills in infants with DS; however, alternative forms of upright
      mobility that are more affordable and less cumbersome are needed. The Upsee (Firefly by
      Leckey, Lisburn, Northern Ireland) shows promise as a dynamic standing device that can be
      used at home by the parent and child to promote upright mobility. This device has not been
      studied in young children with DS.

      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.
    

Intervention name(s): Physical Therapy Home Program
Intervention type(s): Other
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment