Down SyndromeNCT05307523
Use of Partial Body Weight Support Play Environment to Encourage Mobility and Exploration in Infants With Down Syndrome
A study testing Enriched Play Environment with Partial Body Weight Support Harness and Enriched Play Environment without Partial Body Weight Support Harness in people with Down Syndrome and Trisomy 21, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 36 months
- Conditions the study is for
- Down Syndrome, Trisomy 21
- What is being tested?
- Enriched Play Environment with Partial Body Weight Support Harness and Enriched Play Environment without Partial Body Weight Support Harness
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2022to 13 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center on Human Development and Disability (CHDD)
Seattle, Washington, 98195-7920
About this study
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)
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.
Read the 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.
- Conditions
- Down Syndrome, Trisomy 21
- Being tested
- Enriched Play Environment with Partial Body Weight Support Harness, Enriched Play Environment without Partial Body Weight Support Harness
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enriched Play Environment with Partial Body Weight Support HarnessDevice
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 Play Environment without Partial Body Weight Support HarnessOther
Child and caregiver will play freely in the 81 square foot play space without being connected to the partial body weight support harness.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Enriched Play Environment without Partial Body Weight Support Harness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline (week 1) and Final Study (week 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start14 Feb 2022
- Primary completion13 May 2023
- Study completion13 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Feldner, University of Washington
- Investigators
- Heather Feldner, PT, PhD, PCS, Principal investigator, University of Washingon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307523
- Sponsor's protocol ID
- STUDY00014183
- Status last verified
- Apr 2024
- First submitted
- 21 Jan 2022
- Last updated
- 2 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Aggregate data may be shared upon reasonable request to the research team.
Publications
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.
PubMed 32680291Lobo 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.
PubMed 23001524Adolph 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.
PubMed 30256718Waldman-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.
PubMed 25308165Kenyon 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.
PubMed 28853621Huang 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.
PubMed 30098454Gilmore 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.
PubMed 28452583Glenn 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.
PubMed 11721530Almeida 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.
PubMed 7972361Kokkoni 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.
PubMed 29924078Kokkoni 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.
PubMed 32041623Hoffman ME, Abuatiq R, Bokowy K, Fiss AL, Looper J, Steele KM, Feldner HA. Up and down: analyzing physical activity and posture with wearable sensors during partial bodyweight supported play for young children with down syndrome. Dev Neurorehabil. 2026 Aug 1:1-10. doi: 10.1080/17518423.2026.2711427. Online ahead of print.
PubMed 42538843Abuatiq 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.
PubMed 39073058
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05307523
- Acronym / sponsor ID
- STUDY00014183
- Conditions
- Down Syndrome, Trisomy 21
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 13 May 2023 (actual)
- Study completion
- 13 May 2023 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Posted 2 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Enriched Environment Play With Harness Support | Experimental | Device: Enriched Play Environment with Partial Body Weight Support HarnessEnriched 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 Without Harness Support | Active comparator | Other: Enriched Play Environment without Partial Body Weight Support HarnessEnriched environment play, movement, and exploration without additional partial body weight support provided. |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enriched Play Environment with Partial Body Weight Support HarnessA 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. | Device | Enriched Environment Play With Harness Support |
| Enriched Play Environment without Partial Body Weight Support HarnessChild and caregiver will play freely in the 81 square foot play space without being connected to the partial body weight support harness. | Other | Enriched Environment Play Without Harness Support |
Primary outcome
Change in Movement Counts Per 15 Seconds From Baseline (Week 1) to Mid Study (Week 5)
Time frame: Baseline (week 1) and 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.
Change in Movement Counts Per 15 Seconds From Mid Study (Week 5) to Final (Week 9)
Time frame: Mid study (week 5) and Final study (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.
Change in Movement Counts Per 15 Seconds From Baseline (Week 1) to Final (Week 9)
Time frame: Baseline (week 1) and Final Study (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.
Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Baseline (Week 1) to Mid Study (Week 5)
Time frame: Baseline (week 1) and 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.
Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Mid Study (Week 5) to Final (Week 9)
Time frame: 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.
Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Baseline (Week 1) to Final (Weeks 9)
Time frame: Baseline (week 1) to Final study (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.
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)
Time frame: Baseline (week 1) and 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.
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)
Time frame: 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.
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)
Time frame: 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.
3 secondary outcomes
Change in Percentage of Time Spent in Upright (on Feet) Between Baseline (Week 1) and Mid Study (Week 5)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (week 1) and Final Study (week 9)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32680291Campos 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.
- Background: PubMed 23001524Lobo 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.
- Background: PubMed 30256718Adolph 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.
- Background: PubMed 25308165Waldman-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.
- Background: PubMed 28853621Kenyon 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.
- Background: PubMed 30098454Huang 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.
- Background: PubMed 28452583Gilmore 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.
- Background: PubMed 11721530Glenn 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.
- Background: PubMed 7972361Almeida 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.
- Background: PubMed 29924078Kokkoni 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.
- Background: PubMed 32041623Kokkoni 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.
- Derived from this study: PubMed 42538843Hoffman ME, Abuatiq R, Bokowy K, Fiss AL, Looper J, Steele KM, Feldner HA. Up and down: analyzing physical activity and posture with wearable sensors during partial bodyweight supported play for young children with down syndrome. Dev Neurorehabil. 2026 Aug 1:1-10. doi: 10.1080/17518423.2026.2711427. Online ahead of print.
- Individual participant dataSharing planned: No. Aggregate data may be shared upon reasonable request to the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Feldner, PT, PhD, PCS principal investigator
University of Washingon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriched Play Environment with Partial Body Weight Support Harness and Enriched Play Environment without Partial Body Weight Support Harness in people with Down Syndrome and Trisomy 21, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Movement Counts Per 15 Seconds From Baseline (Week 1) to Mid Study (Week 5) (time frame: Baseline (week 1) and mid study (week 5)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05307523, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.