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

NCT05307523 | Completed Results FDA Device

• 1 other identifier: STUDY00014183
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome; Trisomy 21

Outcome Measures

Primary Outcomes (9)

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

  Right Ankle mounted accelerometer (Actigraph GT3X+) data were collected at each assessment point. The sensors were placed on the child's right side ankle and covered with wristbands. The sensors were set to capture data in 1-second epochs during all play sessions. Mean activity counts were calculated by categorizing change in vector magnitude movement counts across a 15-second interval, with higher counts representing more lower extremity movement.

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

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

  Right Ankle mounted accelerometer (Actigraph GT3X+) data were collected at each assessment point. The sensors were placed on the child's right side ankle and covered with wristbands. The sensors were set to capture data in 1-second epochs during all play sessions. Mean activity counts were calculated by categorizing change in vector magnitude movement counts across a 15-second interval, with higher counts representing more lower extremity movement.

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

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

  Right Ankle mounted accelerometer (Actigraph GT3X+) data were collected at each assessment point. The sensors were placed on the child's right side ankle and covered with wristbands. The sensors were set to capture data in 1-second epochs during all play sessions. Mean activity counts were calculated by categorizing change in vector magnitude movement counts across a 15-second interval, with higher counts representing more lower extremity movement.

  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)

  The Gross Motor Function Measure-88 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 in each domain indicate better outcomes. Item scores are summed to calculate raw and percent scores for each of the five GMFM-88 dimensions. Dimension scores are averaged to obtain an overall total score.

  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)

  The Gross Motor Function Measure-88 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 in each domain indicate better outcomes. Item scores are summed to calculate raw and percent scores for each of the five GMFM-88 dimensions. Dimension scores are averaged to obtain an overall total score.

  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)

  The Gross Motor Function Measure-88 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 in each domain indicate better outcomes. Item scores are summed to calculate raw and percent scores for each of the five GMFM-88 dimensions. Dimension scores are averaged to obtain an overall total score.

  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)

  The Revised Dimensions of Mastery Questionnaire has one general competence scale and six mastery motivation scales of persistence: cognitive/object, gross motor, social-adults, social- 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 observed for their child. The general competence score was calculated using the infant scoring formula \[General Competence= Summing the scores of items 4+10+20+27+31, then the total is divided by 5.

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

• 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)

  The Revised Dimensions of Mastery Questionnaire has one general competence scale and six mastery motivation scales of persistence: cognitive/object, gross motor, social-adults, social- 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 observed for their child. The general competence score was calculated using the infant scoring formula \[General Competence= Summing the scores of items 4+10+20+27+31, then the total is divided by 5.

  Mid study (week 5) to Final (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 Final (Week 9)

  The Revised Dimensions of Mastery Questionnaire has one general competence scale and six mastery motivation scales of persistence: cognitive/object, gross motor, social-adults, social- 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 observed for their child. The general competence score was calculated using the infant scoring formula \[General Competence= Summing the scores of items 4+10+20+27+31, then the total is divided by 5.

  Baseline (week 1) to Final (week 9)

Secondary Outcomes (3)

• Change in Percentage of Time Spent in Upright (on Feet) Between Baseline (Week 1) and Mid Study (Week 5)

  From baseline (week 1) to Mid study (week 5)

• Change in Percentage of Time Spent in Upright (on Feet) Between Mid Study (Week 5) and Final (Week 9)

  Mid Study (week 5) to Final (week 9)

• Change in Percentage of Time Spent in Upright (on Feet) Between Baseline (Week 1) and Final Study (Week 9)

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

Study Arms (2)

Enriched Environment Play With Harness Support

EXPERIMENTAL

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

Enriched Environment Play Without Harness Support

ACTIVE COMPARATOR

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

Other: Enriched Play Environment without Partial Body Weight Support Harness

Interventions

Enriched Play Environment with Partial Body Weight Support Harness DEVICE

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.

Enriched Environment Play With Harness Support

Enriched Play Environment without Partial Body Weight Support Harness OTHER

Child and caregiver will play freely in the 81 square foot play space without being connected to the partial body weight support harness.

Enriched Environment Play Without Harness Support

Eligibility Criteria

• Age: Up to 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Center on Human Development and Disability (CHDD)

Seattle, Washington, 98195-7920, United States

Location

Related Publications (12)

• Campos JJ, Anderson DI, Barbu-Roth MA, Hubbard EM, Hertenstein MJ, Witherington D. Travel Broadens the Mind. Infancy. 2000 Apr;1(2):149-219. doi: 10.1207/S15327078IN0102_1. Epub 2000 Apr 1.

  PMID: 32680291 BACKGROUND

• Lobo MA, Harbourne RT, Dusing SC, McCoy SW. Grounding early intervention: physical therapy cannot just be about motor skills anymore. Phys Ther. 2013 Jan;93(1):94-103. doi: 10.2522/ptj.20120158. Epub 2012 Sep 20.

  PMID: 23001524 BACKGROUND

• Adolph KE, Hoch JE. Motor Development: Embodied, Embedded, Enculturated, and Enabling. Annu Rev Psychol. 2019 Jan 4;70:141-164. doi: 10.1146/annurev-psych-010418-102836. Epub 2018 Sep 26.

  PMID: 30256718 BACKGROUND

• Waldman-Levi A, Erez AB. Will environmental interventions affect the level of mastery motivation among children with disabilities? A preliminary study. Occup Ther Int. 2015 Mar;22(1):19-27. doi: 10.1002/oti.1380. Epub 2014 Oct 13.

  PMID: 25308165 BACKGROUND

• Kenyon LK, Farris JP, Aldrich NJ, Rhodes S. Does power mobility training impact a child's mastery motivation and spectrum of EEG activity? An exploratory project. Disabil Rehabil Assist Technol. 2018 Oct;13(7):665-673. doi: 10.1080/17483107.2017.1369587. Epub 2017 Aug 30.

  PMID: 28853621 BACKGROUND

• Huang HH, Huang HW, Chen YM, Hsieh YH, Shih MK, Chen CL. Modified ride-on cars and mastery motivation in young children with disabilities: Effects of environmental modifications. Res Dev Disabil. 2018 Dec;83:37-46. doi: 10.1016/j.ridd.2018.08.001. Epub 2018 Aug 8.

  PMID: 30098454 BACKGROUND

• Gilmore L, Cuskelly M. Associations of Child and Adolescent Mastery Motivation and Self-Regulation With Adult Outcomes: A Longitudinal Study of Individuals With Down Syndrome. Am J Intellect Dev Disabil. 2017 May;122(3):235-246. doi: 10.1352/1944-7558-122.3.235.

  PMID: 28452583 BACKGROUND

• Glenn S, Dayus B, Cunningham C, Horgan M. Mastery motivation in children with Down syndrome. Downs Syndr Res Pract. 2001 Oct;7(2):52-9. doi: 10.3104/reports.114.

  PMID: 11721530 BACKGROUND

• Almeida GL, Corcos DM, Latash ML. Practice and transfer effects during fast single-joint elbow movements in individuals with Down syndrome. Phys Ther. 1994 Nov;74(11):1000-12; discussion 1012-6. doi: 10.1093/ptj/74.11.1000.

  PMID: 7972361 BACKGROUND

• Kokkoni E, Logan SW, Stoner T, Peffley T, Galloway JC. Use of an In-Home Body Weight Support System by a Child With Spina Bifida. Pediatr Phys Ther. 2018 Jul;30(3):E1-E6. doi: 10.1097/PEP.0000000000000516.

  PMID: 29924078 BACKGROUND

• Kokkoni E, Mavroudi E, Zehfroosh A, Galloway JC, Vidal R, Heinz J, Tanner HG. GEARing smart environments for pediatric motor rehabilitation. J Neuroeng Rehabil. 2020 Feb 10;17(1):16. doi: 10.1186/s12984-020-0647-0.

  PMID: 32041623 BACKGROUND

• Abuatiq RA, Hoffman ME, LaForme Fiss A, Looper J, Feldner HA. Exploring the Efficacy of a Dynamic Harness System on Gross Motor Development and Motivation for Infants With Down Syndrome: A Pilot Study. Pediatr Phys Ther. 2024 Oct 1;36(4):468-476. doi: 10.1097/PEP.0000000000001130. Epub 2024 Oct 1.

  PMID: 39073058 DERIVED

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Results Point of Contact

• Title: Reham A. Abuatiq, Research coordinator and a PhD candidate
• Organization: University of Washington

rabuat@uw.edu

6198309638

Study Officials

• Heather Feldner, PT, PhD, PCS

  University of Washingon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine Rehabilitation Medicine

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: April 1, 2022
• Study Start: February 14, 2022
• Primary Completion: May 13, 2023
• Study Completion: May 13, 2023
• Last Updated: May 2, 2024
• Results First Posted: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)