Trial Outcomes & Findings for Use of Partial Body Weight Support Play Environment to Encourage Mobility and Exploration in Infants With Down Syndrome (NCT NCT05307523)
NCT ID: NCT05307523
Last Updated: 2024-05-02
Results Overview
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.
COMPLETED
NA
17 participants
Baseline (week 1) and mid study (week 5)
2024-05-02
Participant Flow
Recruitment started on February 14, 2022, at a research office in the Center on Human Development and Disability (now called Institute on Human Development and Disability) and finished on May 13, 2023.
The initial assignment was random using the Excel randomization Function, then there was a washout period of one week after the first arm is completed
Participant milestones
| Measure |
Group AB Enriched Environment Play (EEP) With Harness First
Enriched environment play, movement, and exploration for children with Down Syndrome while using a harness that provides portable partial body weight support to facilitate movement and exploration. This harness is 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 and provides partial body weight offset to support movement and exploration.
Then, Enriched Play Environment without the harness (Partial Body Weight Support).
The child and caregiver will play freely in the 81-square-foot play space without being connected to the partial body weight support harness.
|
Group BA Enriched Environment Play (EEP) Without Harness First
Enriched environment play, movement, and exploration for children with Down Syndrome while Not using the harness that provides a portable partial body weight support.
Then, Enriched Play Environment with the use of the harness (Partial Body Weight Support). This harness is 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 and provides partial body weight offset to support movement and exploration.
The child and caregiver will play freely in the 81-square-foot play space without being connected to the partial body weight support harness.
|
|---|---|---|
|
First Condition (3 Weeks)
STARTED
|
11
|
6
|
|
First Condition (3 Weeks)
COMPLETED
|
9
|
6
|
|
First Condition (3 Weeks)
NOT COMPLETED
|
2
|
0
|
|
Washout (1 Week)
STARTED
|
9
|
6
|
|
Washout (1 Week)
COMPLETED
|
9
|
6
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Condition (3 Weeks)
STARTED
|
9
|
6
|
|
Second Condition (3 Weeks)
COMPLETED
|
9
|
6
|
|
Second Condition (3 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group AB Enriched Environment Play (EEP) With Harness First
Enriched environment play, movement, and exploration for children with Down Syndrome while using a harness that provides portable partial body weight support to facilitate movement and exploration. This harness is 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 and provides partial body weight offset to support movement and exploration.
Then, Enriched Play Environment without the harness (Partial Body Weight Support).
The child and caregiver will play freely in the 81-square-foot play space without being connected to the partial body weight support harness.
|
Group BA Enriched Environment Play (EEP) Without Harness First
Enriched environment play, movement, and exploration for children with Down Syndrome while Not using the harness that provides a portable partial body weight support.
Then, Enriched Play Environment with the use of the harness (Partial Body Weight Support). This harness is 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 and provides partial body weight offset to support movement and exploration.
The child and caregiver will play freely in the 81-square-foot play space without being connected to the partial body weight support harness.
|
|---|---|---|
|
First Condition (3 Weeks)
Lost to Follow-up
|
1
|
0
|
|
First Condition (3 Weeks)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
These measurements are excluding the 2 participants who dropped out of the AB group.
Baseline characteristics by cohort
| Measure |
Group AB Enriched Environment Play (EEP) With Harness First
n=11 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while using a harness that provides portable partial body weight support to facilitate movement and exploration. This harness is 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 and provides partial body weight offset to support movement and exploration.
Then,Enriched Play Environment without the harness (Partial Body Weight Support).
The child and caregiver will play freely in the 81-square-foot play space without being connected to the partial body weight support harness.
|
Group BA Enriched Environment Play (EEP) Without Harness First
n=6 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while Not using the harness that provides a portable partial body weight support.
Then, Enriched Play Environment with the use of the harness (Partial Body Weight Support). This harness is 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 and provides partial body weight offset to support movement and exploration.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.10 Months
STANDARD_DEVIATION 5.91 • n=11 Participants
|
17.4 Months
STANDARD_DEVIATION 6.56 • n=6 Participants
|
18.39 Months
STANDARD_DEVIATION 6.04 • n=17 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=11 Participants
|
5 Participants
n=6 Participants
|
9 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=11 Participants
|
1 Participants
n=6 Participants
|
8 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=11 Participants
|
2 Participants
n=6 Participants
|
8 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
White & Asian
|
2 Participants
n=11 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native, White
|
1 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=11 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=11 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=17 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=11 Participants
|
6 participants
n=6 Participants
|
17 participants
n=17 Participants
|
|
Movement Counts Per 15 Seconds
|
124.20 movement counts per 15 seconds
STANDARD_DEVIATION 99.99 • n=9 Participants • These measurements are excluding the 2 participants who dropped out of the AB group.
|
227.21 movement counts per 15 seconds
STANDARD_DEVIATION 197.66 • n=6 Participants • These measurements are excluding the 2 participants who dropped out of the AB group.
|
175.71 movement counts per 15 seconds
STANDARD_DEVIATION 148.83 • n=15 Participants • These measurements are excluding the 2 participants who dropped out of the AB group.
|
|
GMFM-88
|
45.7 Score on a scale
STANDARD_DEVIATION 5.6 • n=9 Participants • These measurements exclude the 2 participants who dropped out of the AB group.
|
37.1 Score on a scale
STANDARD_DEVIATION 11.5 • n=6 Participants • These measurements exclude the 2 participants who dropped out of the AB group.
|
41.4 Score on a scale
STANDARD_DEVIATION 8.6 • n=15 Participants • These measurements exclude the 2 participants who dropped out of the AB group.
|
|
DMQ-18 General Competency Scale
|
1.8 score on a scale
STANDARD_DEVIATION 0.52 • n=9 Participants • These measurements are excluding the 2 participants who dropped out of the AB group.
|
1.8 score on a scale
STANDARD_DEVIATION 0.61 • n=6 Participants • These measurements are excluding the 2 participants who dropped out of the AB group.
|
1.8 score on a scale
STANDARD_DEVIATION 0.54 • n=15 Participants • These measurements are excluding the 2 participants who dropped out of the AB group.
|
|
Percentage of time spent upright
|
28.98 percentage of time spent upright
STANDARD_DEVIATION 19.63 • n=9 Participants • These measurements do not include the 2 participants who dropped out of the AB group.
|
23.44 percentage of time spent upright
STANDARD_DEVIATION 16.16 • n=6 Participants • These measurements do not include the 2 participants who dropped out of the AB group.
|
26.21 percentage of time spent upright
STANDARD_DEVIATION 17.90 • n=15 Participants • These measurements do not include the 2 participants who dropped out of the AB group.
|
PRIMARY outcome
Timeframe: Baseline (week 1) and mid study (week 5)Population: 2 Dropped off
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.
Outcome measures
| Measure |
Group AB Enriched Environment Play (EEP) With Harness First
n=9 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while using a harness that provides portable partial body weight support to facilitate movement and exploration. This harness is 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 and provides partial body weight offset to support movement and exploration.
Then, Enriched Play Environment without the harness (Partial Body Weight Support).
The child and caregiver will play freely in the 81-square-foot play space without being connected to the partial body weight support harness.
|
Group BA Enriched Environment Play (EEP) Without Harness First
n=6 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while not using the harness that provides a portable partial body weight support.
Then, Enriched Play Environment with the use of the harness (Partial Body Weight Support). This harness is 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 and provides partial body weight offset to support movement and exploration.
|
|---|---|---|
|
Change in Movement Counts Per 15 Seconds From Baseline (Week 1) to Mid Study (Week 5)
|
-34.46 movement counts per 15 seconds
Standard Deviation 66.93
|
-88.62 movement counts per 15 seconds
Standard Deviation 158.87
|
PRIMARY outcome
Timeframe: Mid study (week 5) and Final study (week 9)Population: 2 dropped out
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.
Outcome measures
| Measure |
Group AB Enriched Environment Play (EEP) With Harness First
n=9 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while using a harness that provides portable partial body weight support to facilitate movement and exploration. This harness is 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 and provides partial body weight offset to support movement and exploration.
Then, Enriched Play Environment without the harness (Partial Body Weight Support).
The child and caregiver will play freely in the 81-square-foot play space without being connected to the partial body weight support harness.
|
Group BA Enriched Environment Play (EEP) Without Harness First
n=6 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while not using the harness that provides a portable partial body weight support.
Then, Enriched Play Environment with the use of the harness (Partial Body Weight Support). This harness is 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 and provides partial body weight offset to support movement and exploration.
|
|---|---|---|
|
Change in Movement Counts Per 15 Seconds From Mid Study (Week 5) to Final (Week 9)
|
28.91 movement counts per 15 seconds
Standard Deviation 61.49
|
-9.75 movement counts per 15 seconds
Standard Deviation 80.89
|
PRIMARY outcome
Timeframe: Baseline (week 1) and Final Study (week 9)Population: 2 dropped out
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.
Outcome measures
| Measure |
Group AB Enriched Environment Play (EEP) With Harness First
n=9 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while using a harness that provides portable partial body weight support to facilitate movement and exploration. This harness is 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 and provides partial body weight offset to support movement and exploration.
Then, Enriched Play Environment without the harness (Partial Body Weight Support).
The child and caregiver will play freely in the 81-square-foot play space without being connected to the partial body weight support harness.
|
Group BA Enriched Environment Play (EEP) Without Harness First
n=6 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while not using the harness that provides a portable partial body weight support.
Then, Enriched Play Environment with the use of the harness (Partial Body Weight Support). This harness is 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 and provides partial body weight offset to support movement and exploration.
|
|---|---|---|
|
Change in Movement Counts Per 15 Seconds From Baseline (Week 1) to Final (Week 9)
|
1.86 movement counts per 15 seconds
Standard Deviation 68.99
|
-98.75 movement counts per 15 seconds
Standard Deviation 122.31
|
PRIMARY outcome
Timeframe: Baseline (week 1) and mid study (week 5)Population: 2 dropped out
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.
Outcome measures
| Measure |
Group AB Enriched Environment Play (EEP) With Harness First
n=9 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while using a harness that provides portable partial body weight support to facilitate movement and exploration. This harness is 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 and provides partial body weight offset to support movement and exploration.
Then, Enriched Play Environment without the harness (Partial Body Weight Support).
The child and caregiver will play freely in the 81-square-foot play space without being connected to the partial body weight support harness.
|
Group BA Enriched Environment Play (EEP) Without Harness First
n=6 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while not using the harness that provides a portable partial body weight support.
Then, Enriched Play Environment with the use of the harness (Partial Body Weight Support). This harness is 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 and provides partial body weight offset to support movement and exploration.
|
|---|---|---|
|
Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Baseline (Week 1) to Mid Study (Week 5)
|
7.01 score on a scale
Standard Deviation 3.09
|
1.57 score on a scale
Standard Deviation 2.89
|
PRIMARY outcome
Timeframe: Mid study (Week 5) to Final (Week 9)Population: 2 dropped out
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.
Outcome measures
| Measure |
Group AB Enriched Environment Play (EEP) With Harness First
n=9 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while using a harness that provides portable partial body weight support to facilitate movement and exploration. This harness is 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 and provides partial body weight offset to support movement and exploration.
Then, Enriched Play Environment without the harness (Partial Body Weight Support).
The child and caregiver will play freely in the 81-square-foot play space without being connected to the partial body weight support harness.
|
Group BA Enriched Environment Play (EEP) Without Harness First
n=6 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while not using the harness that provides a portable partial body weight support.
Then, Enriched Play Environment with the use of the harness (Partial Body Weight Support). This harness is 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 and provides partial body weight offset to support movement and exploration.
|
|---|---|---|
|
Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Mid Study (Week 5) to Final (Week 9)
|
4.17 score on a scale
Standard Deviation 2.85
|
6.28 score on a scale
Standard Deviation 3.04
|
PRIMARY outcome
Timeframe: Baseline (week 1) to Final study (week 9)Population: 2 dropped out
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.
Outcome measures
| Measure |
Group AB Enriched Environment Play (EEP) With Harness First
n=9 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while using a harness that provides portable partial body weight support to facilitate movement and exploration. This harness is 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 and provides partial body weight offset to support movement and exploration.
Then, Enriched Play Environment without the harness (Partial Body Weight Support).
The child and caregiver will play freely in the 81-square-foot play space without being connected to the partial body weight support harness.
|
Group BA Enriched Environment Play (EEP) Without Harness First
n=6 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while not using the harness that provides a portable partial body weight support.
Then, Enriched Play Environment with the use of the harness (Partial Body Weight Support). This harness is 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 and provides partial body weight offset to support movement and exploration.
|
|---|---|---|
|
Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Baseline (Week 1) to Final (Weeks 9)
|
12.38 score on a scale
Standard Deviation 3.84
|
8.81 score on a scale
Standard Deviation 4.0
|
PRIMARY outcome
Timeframe: Baseline (week 1) and mid study (week 5)Population: 2 dropped out
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.
Outcome measures
| Measure |
Group AB Enriched Environment Play (EEP) With Harness First
n=9 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while using a harness that provides portable partial body weight support to facilitate movement and exploration. This harness is 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 and provides partial body weight offset to support movement and exploration.
Then, Enriched Play Environment without the harness (Partial Body Weight Support).
The child and caregiver will play freely in the 81-square-foot play space without being connected to the partial body weight support harness.
|
Group BA Enriched Environment Play (EEP) Without Harness First
n=6 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while not using the harness that provides a portable partial body weight support.
Then, Enriched Play Environment with the use of the harness (Partial Body Weight Support). This harness is 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 and provides partial body weight offset to support movement and exploration.
|
|---|---|---|
|
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)
|
0.47 score on a scale
Standard Deviation 0.32
|
0.5 score on a scale
Standard Deviation 0.52
|
PRIMARY outcome
Timeframe: Mid study (week 5) to Final (week 9)Population: 2 dropped out
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.
Outcome measures
| Measure |
Group AB Enriched Environment Play (EEP) With Harness First
n=9 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while using a harness that provides portable partial body weight support to facilitate movement and exploration. This harness is 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 and provides partial body weight offset to support movement and exploration.
Then, Enriched Play Environment without the harness (Partial Body Weight Support).
The child and caregiver will play freely in the 81-square-foot play space without being connected to the partial body weight support harness.
|
Group BA Enriched Environment Play (EEP) Without Harness First
n=6 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while not using the harness that provides a portable partial body weight support.
Then, Enriched Play Environment with the use of the harness (Partial Body Weight Support). This harness is 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 and provides partial body weight offset to support movement and exploration.
|
|---|---|---|
|
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)
|
0.27 score on a scale
Standard Deviation 0.35
|
0.43 score on a scale
Standard Deviation 0.23
|
PRIMARY outcome
Timeframe: Baseline (week 1) to Final (week 9)Population: 2 dropped out
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.
Outcome measures
| Measure |
Group AB Enriched Environment Play (EEP) With Harness First
n=9 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while using a harness that provides portable partial body weight support to facilitate movement and exploration. This harness is 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 and provides partial body weight offset to support movement and exploration.
Then, Enriched Play Environment without the harness (Partial Body Weight Support).
The child and caregiver will play freely in the 81-square-foot play space without being connected to the partial body weight support harness.
|
Group BA Enriched Environment Play (EEP) Without Harness First
n=6 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while not using the harness that provides a portable partial body weight support.
Then, Enriched Play Environment with the use of the harness (Partial Body Weight Support). This harness is 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 and provides partial body weight offset to support movement and exploration.
|
|---|---|---|
|
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)
|
0.33 score on a scale
Standard Deviation 0.32
|
0.67 score on a scale
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: From baseline (week 1) to Mid study (week 5)Population: 2 dropped out
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.
Outcome measures
| Measure |
Group AB Enriched Environment Play (EEP) With Harness First
n=9 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while using a harness that provides portable partial body weight support to facilitate movement and exploration. This harness is 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 and provides partial body weight offset to support movement and exploration.
Then, Enriched Play Environment without the harness (Partial Body Weight Support).
The child and caregiver will play freely in the 81-square-foot play space without being connected to the partial body weight support harness.
|
Group BA Enriched Environment Play (EEP) Without Harness First
n=6 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while not using the harness that provides a portable partial body weight support.
Then, Enriched Play Environment with the use of the harness (Partial Body Weight Support). This harness is 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 and provides partial body weight offset to support movement and exploration.
|
|---|---|---|
|
Change in Percentage of Time Spent in Upright (on Feet) Between Baseline (Week 1) and Mid Study (Week 5)
|
9.61 percentage of time spent in upright
Standard Deviation 31.83
|
-3.51 percentage of time spent in upright
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: Mid Study (week 5) to Final (week 9)Population: 2 dropped out
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.
Outcome measures
| Measure |
Group AB Enriched Environment Play (EEP) With Harness First
n=9 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while using a harness that provides portable partial body weight support to facilitate movement and exploration. This harness is 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 and provides partial body weight offset to support movement and exploration.
Then, Enriched Play Environment without the harness (Partial Body Weight Support).
The child and caregiver will play freely in the 81-square-foot play space without being connected to the partial body weight support harness.
|
Group BA Enriched Environment Play (EEP) Without Harness First
n=6 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while not using the harness that provides a portable partial body weight support.
Then, Enriched Play Environment with the use of the harness (Partial Body Weight Support). This harness is 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 and provides partial body weight offset to support movement and exploration.
|
|---|---|---|
|
Change in Percentage of Time Spent in Upright (on Feet) Between Mid Study (Week 5) and Final (Week 9)
|
1.7 percentage of time spent in upright
Standard Deviation 15.7
|
5.8 percentage of time spent in upright
Standard Deviation 28.6
|
SECONDARY outcome
Timeframe: Baseline (week 1) and Final Study (week 9)Population: 2 dropped out
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.
Outcome measures
| Measure |
Group AB Enriched Environment Play (EEP) With Harness First
n=9 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while using a harness that provides portable partial body weight support to facilitate movement and exploration. This harness is 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 and provides partial body weight offset to support movement and exploration.
Then, Enriched Play Environment without the harness (Partial Body Weight Support).
The child and caregiver will play freely in the 81-square-foot play space without being connected to the partial body weight support harness.
|
Group BA Enriched Environment Play (EEP) Without Harness First
n=6 Participants
Enriched environment play, movement, and exploration for children with Down Syndrome while not using the harness that provides a portable partial body weight support.
Then, Enriched Play Environment with the use of the harness (Partial Body Weight Support). This harness is 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 and provides partial body weight offset to support movement and exploration.
|
|---|---|---|
|
Change in Percentage of Time Spent in Upright (on Feet) Between Baseline (Week 1) and Final Study (Week 9)
|
14.9 percentage of time spent in upright
Standard Deviation 20.8
|
3.56 percentage of time spent in upright
Standard Deviation 23.3
|
Adverse Events
Group AB Enriched Environment Play (EEP) With Harness
Group BA Enriched Environment Play (EEP) Without Harness
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Reham A. Abuatiq, Research coordinator and a PhD candidate
University of Washington
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place