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

Down Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05307523
• Other study ID #: STUDY00014183
• Status: Completed
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: May 13, 2023

Study information

• Verified date: April 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 13, 2023
• Est. primary completion date: May 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Down Syndrome
• Syndrome
• Trisomy 21

Intervention

Device:
• Enriched Play Environment with Partial Body Weight Support Harness
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.

Other:
• Enriched Play Environment without Partial Body Weight Support Harness
Child and caregiver will play freely in the 81 square foot play space without being connected to the partial body weight support harness.

Locations

Country	Name	City	State
United States	Center on Human Development and Disability (CHDD)	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
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)	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)
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)	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)
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)	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	Change in Percentage of Time Spent in Upright (on Feet) Between Baseline (Week 1) and Mid Study (Week 5)	Percentage of time spent in upright positions (supported or unsupported standing, supported stepping, cruising), were assessed from R ankle-worn accelerometer data. Position was calculated using tri-axial orientation values of the accelerometer relative to the ground, and were verified using a behavioral video coding scheme that document child positioning every 6 seconds during a 30 minute play session. Percentage of time spent in each position was calculated at each assessment point, with higher percentages equating to more time spent upright and on feet.	From baseline (week 1) to Mid study (week 5)
Secondary	Change in Percentage of Time Spent in Upright (on Feet) Between Mid Study (Week 5) and Final (Week 9)	Percentage of time spent in upright positions (supported or unsupported standing, supported stepping, cruising), were assessed from R ankle-worn accelerometer data. Position was calculated using tri-axial orientation values of the accelerometer relative to the ground, and were verified using a behavioral video coding scheme that document child positioning every 6 seconds during a 30 minute play session. Percentage of time spent in each position was calculated at each assessment point, with higher percentages equating to more time spent upright and on feet.	Mid Study (week 5) to Final (week 9)
Secondary	Change in Percentage of Time Spent in Upright (on Feet) Between Baseline (Week 1) and Final Study (Week 9)	Percentage of time spent in upright positions (supported or unsupported standing, supported stepping, cruising), were assessed from R ankle-worn accelerometer data. Position was calculated using tri-axial orientation values of the accelerometer relative to the ground, and were verified using a behavioral video coding scheme that document child positioning every 6 seconds during a 30 minute play session. Percentage of time spent in each position was calculated at each assessment point, with higher percentages equating to more time spent upright and on feet.	Baseline (week 1) and Final Study (week 9)