N/A
N=36
SmarToyGym: Smart Detection of Atypical Toy-oriented Actions in At-risk Infants
Cerebral Palsy · Developmental Delay · Stroke · Fine Motor Delay · Infant Development
Bottom Line
View on ClinicalTrials.gov: NCT02813889 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Center of Pressure, Path Length Per Second - No Toy (Birth Status) — 0.0282; 0.0428 centimeters per second (cm/sec) — p=0.0054
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SmarToyGym (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Center of Pressure, Path Length Per Second - No Toy (Birth Status) |
0.0282; 0.0428 | 0.0054 sig |
| PRIMARY Center of Pressure, Path Length Per Second - Elephant Toy (Birth Status) |
0.0311; 0.0508 | 0.0005 sig |
| PRIMARY Center of Pressure, Path Length Per Second - Orangutan Toy (Birth Status) |
0.0251; 0.0417 | 0.0088 sig |
| PRIMARY Center of Pressure, Path Length Per Second - Lion Toy (Birth Status) |
0.0342; 0.0421 | 0.7624 |
| PRIMARY Center of Pressure, Path Length Per Second - No Toy (Motor Control Outcome) |
0.0287; 0.0416 | 0.0326 sig |
| PRIMARY Center of Pressure, Path Length Per Second - Elephant Toy (Motor Control Outcome) |
0.0312; 0.0617 | <0.0001 sig |
| PRIMARY Center of Pressure, Path Length Per Second - Orangutan Toy (Motor Control Outcome) |
0.0260; 0.0445 | 0.0025 sig |
| PRIMARY Center of Pressure, Path Length Per Second - Lion Toy (Motor Control Outcome) |
0.0335; 0.0416 | 0.6782 |
| PRIMARY Center of Pressure, Standard Deviation (Y) - No Toy (Birth Status) |
1.863; 0.799 | 0.0479 sig |
| PRIMARY Center of Pressure, Standard Deviation (Y) - Elephant Toy (Birth Status) |
1.520; 1.159 | 0.9947 |
| PRIMARY Center of Pressure, Standard Deviation (Y) - Orangutan Toy (Birth Status) |
1.857; 0.890 | 0.2614 |
| PRIMARY Center of Pressure, Standard Deviation (Y) - Lion Toy (Birth Status) |
2.046; 0.738 | 0.0314 sig |
| PRIMARY Center of Pressure, Standard Deviation (Y) - No Toy (Motor Control Outcome) |
1.6920; 0.6177 | 0.0958 |
| PRIMARY Center of Pressure, Standard Deviation (Y) - Elephant Toy (Motor Control Outcome) |
1.3491; 1.6428 | 0.9660 |
| PRIMARY Center of Pressure, Standard Deviation (Y) - Orangutan Toy (Motor Control Outcome) |
1.5857; 1.0820 | 0.9462 |
| PRIMARY Center of Pressure, Standard Deviation (Y) - Lion Toy (Motor Control Outcome) |
1.8048; 0.6503 | 0.1129 |
| PRIMARY Toy Interaction (Elephant Toy) - Grasp/Touch/Kick/Mouth Time |
90.7; 0 | — |
| PRIMARY Toy Interaction (Orangutan Toy) - Grasp/Touch/Kick/Mouth Time |
69.3; 27.9 | — |
| PRIMARY Toy Interaction (Lion Toy) - Grasp/Touch/Kick/Mouth Time |
2.2; 0 | — |
| PRIMARY Toy Interaction (Elephant Toy) - Gaze Time |
59.6; 0 | — |
| PRIMARY Toy Interaction (Orangutan Toy) - Gaze Time |
83.5; 44.8 | — |
| PRIMARY Toy Interaction (Lion Toy) - Gaze Time |
21.7; 0 | — |
| PRIMARY Number of Occurrences of Elephant Toy Interactions |
22.5; 0 | — |
| PRIMARY Number of Occurrences of Orangutan Toy Interactions |
7; 7 | — |
| PRIMARY Number of Occurrences of Lion Toy Interactions |
1; 0 | — |
| SECONDARY Wrist Position |
0.008; 0.088; -0.044; 0.370; 0.268; 0.224 | — |
| SECONDARY Ankle Position |
-0.018; 0.017; -0.056; 1.580; 1.472; 1.348 | — |
| SECONDARY Wrist Velocity |
0.034; 0.048; 0.048; 0.035; 0.045; 0.054 | — |
| SECONDARY Ankle Velocity |
0.052; 0.072; 0.067; 0.041; 0.067; 0.062 | — |
Summary
The study aims to develop a SmarToyGym where sensitized, wireless toys are strategically hung and placed within reach of infants to elicit toy-oriented body and arm/hand movements. Each toy will be equipped with sensors capable of measuring the infant's grasping actions such as squeezing, pinching, tilting, etc.
A low-cost 3D motion capture system will be used to collect video data and the infants' reaching and body kinematics in response to the toys. A pressure mat will be used to measure postural changes to detect weight shifts, rolling, crawling and other movements away from the initial posture. By capitalizing on these wireless and low-cost technologies, it will permit the regular and non-invasive monitoring of infants, which can lead to detailed, non-obtrusive, quantitative evaluation of motor development. In this vein, the investigators also aim to conduct proof-of-concept testing of the SmarToyGym with atypical and typical developing infants. The investigators will include infants' ages 3 to 11 months who are categorized as high-risk or low-risk using the Bayley Infant Neurodevelopmental Screener.
Eligibility Criteria
Inclusion Criteria
- Infants exhibiting typical development between 3 months and 11 months of age who score in the low-risk category on the Bayley Infant Neurodevelopment Screener (BINS), score greater than 85 on all sub-scales of the Bayley Scale of Infant Development (BSID-II), have no history of significant cardiac, orthopedic or neurological condition and have a gestational age at least 37 weeks.
- Infants exhibiting atypical development (at-risk for neuromotor delay) between 3 months and 11 months of age, score in the moderate or high risk categories on the BINS, and score an 85 or less on the motor sub-scales of the BSID-II.
- Exclusion Criteria:
- Infants outside age range of 3-11 months
Data sourced from ClinicalTrials.gov (NCT02813889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.