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

Primary Purpose

Down Syndrome, Trisomy 21

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enriched Play Environment with Partial Body Weight Support Harness
Enriched Play Environment without Partial Body Weight Support Harness
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Down Syndrome

Eligibility Criteria

undefined - 36 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center on Human Development and Disability (CHDD)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enriched Environment Play With Harness Support

Enriched Environment Play Without Harness Support

Arm Description

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.

Enriched environment play, movement, and exploration without additional partial body weight support provided.

Outcomes

Primary Outcome Measures

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.
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.
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.
Behavioral Observation Coding Metric 1
Frequency of exploratory behaviors will be documented via behavioral video coding from session video recordings.
Behavioral Observation Coding Metric 2
Duration of exploratory behaviors will be documented via behavioral video coding from session video recordings.
Behavioral Observation Coding Metric 3
Body position of exploratory behaviors will be documented via behavioral video coding from session video recordings.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2022
Last Updated
April 29, 2023
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT05307523
Brief Title
Use of Partial Body Weight Support Play Environment to Encourage Mobility and Exploration in Infants With Down Syndrome
Official Title
Up and Down: Use of Dynamic Partial Body Weight Support Play Environment to Encourage Upright Mobility and Exploration in Infants With Down Syndrome (DS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome, Trisomy 21

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enriched Environment Play With Harness Support
Arm Type
Experimental
Arm Description
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.
Arm Title
Enriched Environment Play Without Harness Support
Arm Type
Active Comparator
Arm Description
Enriched environment play, movement, and exploration without additional partial body weight support provided.
Intervention Type
Device
Intervention Name(s)
Enriched Play Environment with Partial Body Weight Support Harness
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enriched Play Environment without Partial Body Weight Support Harness
Intervention Description
Child and caregiver will play freely in the 81 square foot play space without being connected to the partial body weight support harness.
Primary Outcome Measure Information:
Title
Change in Movement Counts
Description
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.
Time Frame
Through study completion, an average of 9 weeks.
Title
Change in gross motor performance using the Gross Motor Function Measure (GMFM-88) scores
Description
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.
Time Frame
Through study completion, an average of 9 weeks.
Title
Change in Caregiver Perception of their Child's Mastery motivation using the Revised Dimensions of Mastery Questionnaire (DMQ-18) infant version
Description
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.
Time Frame
Through study completion, an average of 9 weeks.
Title
Behavioral Observation Coding Metric 1
Description
Frequency of exploratory behaviors will be documented via behavioral video coding from session video recordings.
Time Frame
Through study completion, an average of 9 weeks.
Title
Behavioral Observation Coding Metric 2
Description
Duration of exploratory behaviors will be documented via behavioral video coding from session video recordings.
Time Frame
Through study completion, an average of 9 weeks.
Title
Behavioral Observation Coding Metric 3
Description
Body position of exploratory behaviors will be documented via behavioral video coding from session video recordings.
Time Frame
Through study completion, an average of 9 weeks.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reham Abuatiq
Phone
619-830-9638
Email
rabuat@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Feldner, PT, PhD, PCS
Organizational Affiliation
University of Washingon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center on Human Development and Disability (CHDD)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-7920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reham A Abuatiq, Master
Phone
619-830-9638
Email
rabuat@uw.edu
First Name & Middle Initial & Last Name & Degree
Mia Hoffman, Master
Email
miahoff@uw.edu
First Name & Middle Initial & Last Name & Degree
Heather Feldner, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate data may be shared upon reasonable request to the research team.
Citations:
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Use of Partial Body Weight Support Play Environment to Encourage Mobility and Exploration in Infants With Down Syndrome

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