CompletedNot Applicable

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

United States17 participantsStarted 2022-02-14

Plain-language 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.

Who can participate

Age range36 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Movement Counts Per 15 Seconds From Baseline (Week 1) to Mid Study (Week 5)

Timeframe: Baseline (week 1) and mid study (week 5)

Change in Movement Counts Per 15 Seconds From Mid Study (Week 5) to Final (Week 9)

Timeframe: Mid study (week 5) and Final study (week 9)

Change in Movement Counts Per 15 Seconds From Baseline (Week 1) to Final (Week 9)

Timeframe: Baseline (week 1) and Final Study (week 9)

Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Baseline (Week 1) to Mid Study (Week 5)

Timeframe: Baseline (week 1) and mid study (week 5)

Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Mid Study (Week 5) to Final (Week 9)

Timeframe: Mid study (Week 5) to Final (Week 9)

Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Baseline (Week 1) to Final (Weeks 9)

Timeframe: Baseline (week 1) to Final study (week 9)

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)

Trial details

NCT IDNCT05307523

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-13

Results submitted2024-01-15

View on ClinicalTrials.gov More Down Syndrome trials

Plain-language summary

Who can participate

Age range36 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Movement Counts Per 15 Seconds From Baseline (Week 1) to Mid Study (Week 5)

Timeframe: Baseline (week 1) and mid study (week 5)

Change in Movement Counts Per 15 Seconds From Mid Study (Week 5) to Final (Week 9)

Timeframe: Mid study (week 5) and Final study (week 9)

Change in Movement Counts Per 15 Seconds From Baseline (Week 1) to Final (Week 9)

Timeframe: Baseline (week 1) and Final Study (week 9)

Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Baseline (Week 1) to Mid Study (Week 5)

Timeframe: Baseline (week 1) and mid study (week 5)

Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Mid Study (Week 5) to Final (Week 9)

Timeframe: Mid study (Week 5) to Final (Week 9)

Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Baseline (Week 1) to Final (Weeks 9)

Timeframe: Baseline (week 1) to Final study (week 9)

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)