Use of Partial Body Weight Support Play Environment to Encourage Mobility and Exploration in Infants With Down Syndrome

Study Overview
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Brief Summary
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To explore the effects of Partial Body Weight Support (PBWS) within an enriched play environment for infants with Down Syndrome (DS), who are not yet walking, to better understand how PWBS may impact their mobility; exploration; and overall activity level. Hypothesis1 A: Infants will demonstrate increased movement counts on an ActiGraph during intervention compared to a control phase. Hypothesis 1B: Infants will demonstrate a higher frequency of exploratory behaviors during the intervention as compared to a control phase. Hypothesis 2: Infants will demonstrate an increased rate of improvement in Gross Motor Function Measure scores after the intervention compared to a control phase. Hypothesis 3: Infants will demonstrate higher parent-reported mastery motivation on the Dimensions of Mastery Questionnaire after the intervention compared to a control phase.

Detailed Description
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The procedures will take place within a portable play area, which includes toys and a partial body weight mobile harness system to assist the child in moving and exploring safely within the play area. Infants will always play and explore in this same area during the study but sometimes they will wear the PBWS harness and sometimes they will not wear the harness. During the intervention play sessions, the child will have the harness on. During the control play sessions, the child will play in the play area without the harness on. The child will participate in the intervention play sessions (using the harness) for 3 weeks, and in the control play sessions for 3 weeks. Before the first visit, this will be done randomly which group (intervention or control) the child will start with. Children will switch groups after week 5 of the study. Week 1: assessment week, single session for 1 hour. At this first session, the investigators will do a developmental test for the child to see how they move around. This test will be videotaped. The investigators will also ask the caregiver to fill out a survey that asks caregivers questions about the motivation of their child and how they learn and play. Week 2-4: play sessions, three times/week for one hour each. At each play session, the investigators will videotape the child playing and also place a small activity monitor on one wrist and one ankle. The session will end when the child has played in the play area for 30 minutes or the child has been present for 60 minutes, whichever comes first. Week 5: assessment week, single session for 1 hour. The tests and surveys from the first week will be repeated. The child will then switch groups to or from the intervention group or the control group. Weeks 6-8: play sessions, 3 times/week for one hour each. The child will participate in the same activities as described above but in the opposite group. Week 9: assessment single session for 1 hour. The tests and surveys from week 1 and week 5 will be repeated a final time. The study will be over after this visit. During all play and testing sessions, children will be given breaks as needed or if the caregiver request one. Caregivers will be able to play and interact with the child as they usually do throughout the play session and will be present in the play area with their children at all times.

Official Title
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Up and Down: Use of Dynamic Partial Body Weight Support Play Environment to Encourage Upright Mobility and Exploration in Infants With Down Syndrome (DS)

Conditions
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Down Syndrome, Trisomy 21

Intervention / Treatment
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* Device: Enriched Play Environment with Partial Body Weight Support Harness
* Other: Enriched Play Environment without Partial Body Weight Support Harness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A medical diagnosis of DS (any form) Under 36 months old Able to sit independently One parent must be able to read proficiently enough in English to complete a written assessment. Exclusion Criteria: The child is already taking independent steps The child has uncontrolled seizures The child has known medical precautions that would prohibit them from wearing a harness The child has other developmental disability diagnoses.

Ages Eligible for Study
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Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This pilot study uses a randomized, crossover design with children serving as their own controls. Study activities for each child will take place over 9 weeks. Children and their families will come to one of the research labs to participate, one family at a time. On the first visit, parents will be asked to review and sign an informed consent document to participate and baseline assessments will be completed. The intervention will take place during weeks 2-4 and weeks 6-8, with a washout and reassessment period during week 5 prior to crossover. A final reassessment session will take place during week 9.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enriched Environment Play With Harness Support<br>Enriched environment play, movement, and exploration for children with Down Syndrome while using a portable partial body weight support harness to facilitate movement and exploration. | Device: Enriched Play Environment with Partial Body Weight Support Harness<br>* A low-tech portable canopy with a partial-body weight harness system that allows a child and their caregiver to play freely in an 81 square foot space, which provides partial body weight offset to support movement and exploration.<br>|
| Active Comparator: Enriched Environment Play Without Harness Support<br>Enriched environment play, movement, and exploration without additional partial body weight support provided. | Other: Enriched Play Environment without Partial Body Weight Support Harness<br>* Child and caregiver will play freely in the 81 square foot play space without being connected to the partial body weight support harness.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Movement Counts | Wrist and ankle mounted accelerometers (Actigraph GT3X+). The sensors will be placed on the child's right side wrist and ankle and covered with wrist bands. The sensors will be set to capture data in 1-second epochs during all play sessions. | Through study completion, an average of 9 weeks. | 
| Change in gross motor performance using the Gross Motor Function Measure (GMFM-88) scores | The Gross Motor Function Measure-88 (GMFM) is a standardized, validated outcome measure in children with Down Syndrome used to assess progress in gross motor development domains of lying and rolling (score range 0-51), sitting (score range 0-60), crawling and kneeling (score range 0-42), standing (score range 0-39) and walking, running, and jumping (score range 0-72). Higher scores indicate better outcomes. | Through study completion, an average of 9 weeks. | 
| Change in Caregiver Perception of their Child's Mastery motivation using the Revised Dimensions of Mastery Questionnaire (DMQ-18) infant version | The Revised DMQ-18 has one general competence scale and six mastery motivation scales including: cognitive/object persistence, gross motor persistence, social persistence with adults, social persistence with children/peers, mastery pleasure, and negative reactions to challenge in mastery situations. It is completed by caregivers and has a score range of 41-205, with higher scores indicating greater mastery motivation. | Through study completion, an average of 9 weeks. | 
| Behavioral Observation Coding Metric 1 | Frequency of exploratory behaviors will be documented via behavioral video coding from session video recordings. | Through study completion, an average of 9 weeks. | 
| Behavioral Observation Coding Metric 2 | Duration of exploratory behaviors will be documented via behavioral video coding from session video recordings. | Through study completion, an average of 9 weeks. | 
| Behavioral Observation Coding Metric 3 | Body position of exploratory behaviors will be documented via behavioral video coding from session video recordings. | Through study completion, an average of 9 weeks. |