N/A N=17 Randomized Other

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

Down Syndrome · Trisomy 21

Bottom Line

View on ClinicalTrials.gov: NCT05307523 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2024

Primary outcome: Primary: Change in Movement Counts Per 15 Seconds From Baseline (Week 1) to Mid Study (Week 5) — -34.46; -88.62 movement counts per 15 seconds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Enriched Play Environment with Partial Body Weight Support Harness (Device); Enriched Play Environment without Partial Body Weight Support Harness (Other)
Age: Pediatric
Sex: All
Sponsor: University of Washington
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Movement Counts Per 15 Seconds From Baseline (Week 1) to Mid Study (Week 5)	-34.46; -88.62	—
PRIMARY Change in Movement Counts Per 15 Seconds From Mid Study (Week 5) to Final (Week 9)	28.91; -9.75	—
PRIMARY Change in Movement Counts Per 15 Seconds From Baseline (Week 1) to Final (Week 9)	1.86; -98.75	—
PRIMARY Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Baseline (Week 1) to Mid Study (Week 5)	7.01; 1.57	<0.05 sig
PRIMARY Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Mid Study (Week 5) to Final (Week 9)	4.17; 6.28	—
PRIMARY Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Baseline (Week 1) to Final (Weeks 9)	12.38; 8.81	—
PRIMARY Change in Caregiver Perception of Their Child's Mastery Motivation Using the Revised Dimensions of Mastery Questionnaire-18 Infant Version From Baseline (Week 1) to Mid Study (Week 5)	0.47; 0.5	—
PRIMARY Change in Caregiver Perception of Their Child's Mastery Motivation Using the Revised Dimensions of Mastery Questionnaire-18 Infant Version From Mid Study (Week 5) to Final (Week 9)	0.27; 0.43	—
PRIMARY Change in Caregiver Perception of Their Child's Mastery Motivation Using the Revised Dimensions of Mastery Questionnaire-18 Infant Version From Baseline (Week 1) to Final (Week 9)	0.33; 0.67	—
SECONDARY Change in Percentage of Time Spent in Upright (on Feet) Between Baseline (Week 1) and Mid Study (Week 5)	9.61; -3.51	—
SECONDARY Change in Percentage of Time Spent in Upright (on Feet) Between Mid Study (Week 5) and Final (Week 9)	1.7; 5.8	—
SECONDARY Change in Percentage of Time Spent in Upright (on Feet) Between Baseline (Week 1) and Final Study (Week 9)	14.9; 3.56	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05307523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.