Down Syndrome, Trisomy 21
Conditions
Brief summary
To explore the effects of Partial Body Weight Support (PBWS) within an enriched play environment for infants with Down Syndrome (DS), who are not yet walking, to better understand how PWBS may impact their mobility; exploration; and overall activity level. * Hypothesis1 A: Infants will demonstrate increased movement counts on an ActiGraph during intervention compared to a control phase. Hypothesis 1B: Infants will demonstrate a higher frequency of exploratory behaviors during the intervention as compared to a control phase. * Hypothesis 2: Infants will demonstrate an increased rate of improvement in Gross Motor Function Measure scores after the intervention compared to a control phase. * Hypothesis 3: Infants will demonstrate higher parent-reported mastery motivation on the Dimensions of Mastery Questionnaire after the intervention compared to a control phase.
Detailed description
The procedures will take place within a portable play area, which includes toys and a partial body weight mobile harness system to assist the child in moving and exploring safely within the play area. Infants will always play and explore in this same area during the study but sometimes they will wear the PBWS harness and sometimes they will not wear the harness. During the intervention play sessions, the child will have the harness on. During the control play sessions, the child will play in the play area without the harness on. The child will participate in the intervention play sessions (using the harness) for 3 weeks, and in the control play sessions for 3 weeks. Before the first visit, this will be done randomly which group (intervention or control) the child will start with. Children will switch groups after week 5 of the study. Week 1: assessment week, single session for 1 hour. At this first session, the investigators will do a developmental test for the child to see how they move around. This test will be videotaped. The investigators will also ask the caregiver to fill out a survey that asks caregivers questions about the motivation of their child and how they learn and play. Week 2-4: play sessions, three times/week for one hour each. At each play session, the investigators will videotape the child playing and also place a small activity monitor on one wrist and one ankle. The session will end when the child has played in the play area for 30 minutes or the child has been present for 60 minutes, whichever comes first. Week 5: assessment week, single session for 1 hour. The tests and surveys from the first week will be repeated. The child will then switch groups to or from the intervention group or the control group. Weeks 6-8: play sessions, 3 times/week for one hour each. The child will participate in the same activities as described above but in the opposite group. Week 9: assessment single session for 1 hour. The tests and surveys from week 1 and week 5 will be repeated a final time. The study will be over after this visit. During all play and testing sessions, children will be given breaks as needed or if the caregiver request one. Caregivers will be able to play and interact with the child as they usually do throughout the play session and will be present in the play area with their children at all times.
Interventions
DEVICEEnriched 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.
OTHEREnriched 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.
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 36 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Baseline (Week 1) to Final (Weeks 9) | 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) | 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) | 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 Movement Counts Per 15 Seconds From Baseline (Week 1) to Mid Study (Week 5) | 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) | 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) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage of Time Spent in Upright (on Feet) Between Mid Study (Week 5) and Final (Week 9) | Mid Study (week 5) to Final (week 9) | 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. |
| Change in Percentage of Time Spent in Upright (on Feet) Between Baseline (Week 1) and Final Study (Week 9) | Baseline (week 1) and Final Study (week 9) | 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. |
| Change in Percentage of Time Spent in Upright (on Feet) Between Baseline (Week 1) and Mid Study (Week 5) | From baseline (week 1) to Mid study (week 5) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| 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. | 6 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Condition (3 Weeks) | Lost to Follow-up | 1 | 0 |
| First Condition (3 Weeks) | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Group BA Enriched Environment Play (EEP) Without Harness First | Total | Group AB Enriched Environment Play (EEP) With Harness First |
|---|---|---|---|
| Age, Continuous | 17.4 Months STANDARD_DEVIATION 6.56 | 18.39 Months STANDARD_DEVIATION 6.04 | 19.10 Months STANDARD_DEVIATION 5.91 |
| DMQ-18 General Competency Scale | 1.8 score on a scale STANDARD_DEVIATION 0.61 | 1.8 score on a scale STANDARD_DEVIATION 0.54 | 1.8 score on a scale STANDARD_DEVIATION 0.52 |
| GMFM-88 | 37.1 Score on a scale STANDARD_DEVIATION 11.5 | 41.4 Score on a scale STANDARD_DEVIATION 8.6 | 45.7 Score on a scale STANDARD_DEVIATION 5.6 |
| Movement Counts Per 15 Seconds | 227.21 movement counts per 15 seconds STANDARD_DEVIATION 197.66 | 175.71 movement counts per 15 seconds STANDARD_DEVIATION 148.83 | 124.20 movement counts per 15 seconds STANDARD_DEVIATION 99.99 |
| Percentage of time spent upright | 23.44 percentage of time spent upright STANDARD_DEVIATION 16.16 | 26.21 percentage of time spent upright STANDARD_DEVIATION 17.9 | 28.98 percentage of time spent upright STANDARD_DEVIATION 19.63 |
| Race/Ethnicity, Customized American Indian or Alaska Native, White | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 8 Participants | 6 Participants |
| Race/Ethnicity, Customized White & Asian | 2 Participants | 4 Participants | 2 Participants |
| Region of Enrollment United States | 6 participants | 17 participants | 11 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 8 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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.
Time frame: Baseline (week 1) to Final (week 9)
Population: 2 dropped out
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group AB Enriched Environment Play (EEP) With Harness First | 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 |
| Group BA Enriched Environment Play (EEP) Without Harness First | 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) | 0.67 score on a scale | Standard Deviation 0.37 |
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.
Time frame: Baseline (week 1) and mid study (week 5)
Population: 2 dropped out
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group AB Enriched Environment Play (EEP) With Harness First | 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 |
| Group BA Enriched Environment Play (EEP) Without Harness First | 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) | 0.5 score on a scale | Standard Deviation 0.52 |
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.
Time frame: Mid study (week 5) to Final (week 9)
Population: 2 dropped out
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group AB Enriched Environment Play (EEP) With Harness First | 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 |
| Group BA Enriched Environment Play (EEP) Without Harness First | 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) | 0.43 score on a scale | Standard Deviation 0.23 |
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.
Time frame: Baseline (week 1) to Final study (week 9)
Population: 2 dropped out
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group AB Enriched Environment Play (EEP) With Harness First | 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 |
| Group BA Enriched Environment Play (EEP) Without Harness First | Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Baseline (Week 1) to Final (Weeks 9) | 8.81 score on a scale | Standard Deviation 4 |
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.
Time frame: Baseline (week 1) and mid study (week 5)
Population: 2 dropped out
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group AB Enriched Environment Play (EEP) With Harness First | 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 |
| Group BA Enriched Environment Play (EEP) Without Harness First | Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Baseline (Week 1) to Mid Study (Week 5) | 1.57 score on a scale | Standard Deviation 2.89 |
p-value: <0.05Both Paired T-test and Wilcoxon Rank
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.
Time frame: Mid study (Week 5) to Final (Week 9)
Population: 2 dropped out
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group AB Enriched Environment Play (EEP) With Harness First | 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 |
| Group BA Enriched Environment Play (EEP) Without Harness First | Change in Gross Motor Performance Using the Gross Motor Function Measure-88 Scores From Mid Study (Week 5) to Final (Week 9) | 6.28 score on a scale | Standard Deviation 3.04 |
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.
Time frame: Baseline (week 1) and Final Study (week 9)
Population: 2 dropped out
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group AB Enriched Environment Play (EEP) With Harness First | 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 |
| Group BA Enriched Environment Play (EEP) Without Harness First | Change in Movement Counts Per 15 Seconds From Baseline (Week 1) to Final (Week 9) | -98.75 movement counts per 15 seconds | Standard Deviation 122.31 |
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.
Time frame: Baseline (week 1) and mid study (week 5)
Population: 2 Dropped off
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group AB Enriched Environment Play (EEP) With Harness First | 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 |
| Group BA Enriched Environment Play (EEP) Without Harness First | Change in Movement Counts Per 15 Seconds From Baseline (Week 1) to Mid Study (Week 5) | -88.62 movement counts per 15 seconds | Standard Deviation 158.87 |
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.
Time frame: Mid study (week 5) and Final study (week 9)
Population: 2 dropped out
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group AB Enriched Environment Play (EEP) With Harness First | 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 |
| Group BA Enriched Environment Play (EEP) Without Harness First | Change in Movement Counts Per 15 Seconds From Mid Study (Week 5) to Final (Week 9) | -9.75 movement counts per 15 seconds | Standard Deviation 80.89 |
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.
Time frame: Baseline (week 1) and Final Study (week 9)
Population: 2 dropped out
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group AB Enriched Environment Play (EEP) With Harness First | 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 |
| Group BA Enriched Environment Play (EEP) Without Harness First | Change in Percentage of Time Spent in Upright (on Feet) Between Baseline (Week 1) and Final Study (Week 9) | 3.56 percentage of time spent in upright | Standard Deviation 23.3 |
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.
Time frame: From baseline (week 1) to Mid study (week 5)
Population: 2 dropped out
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group AB Enriched Environment Play (EEP) With Harness First | 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 |
| Group BA Enriched Environment Play (EEP) Without Harness First | Change in Percentage of Time Spent in Upright (on Feet) Between Baseline (Week 1) and Mid Study (Week 5) | -3.51 percentage of time spent in upright | Standard Deviation 15.1 |
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.
Time frame: Mid Study (week 5) to Final (week 9)
Population: 2 dropped out
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group AB Enriched Environment Play (EEP) With Harness First | 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 |
| Group BA Enriched Environment Play (EEP) Without Harness First | Change in Percentage of Time Spent in Upright (on Feet) Between Mid Study (Week 5) and Final (Week 9) | 5.8 percentage of time spent in upright | Standard Deviation 28.6 |